[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Notices]
[Pages 64074-64100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31741]
[[Page 64073]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
Final Guidance on Industry-Supported Scientific and Educational
Activities; Notice
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 /
Notices
[[Page 64074]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92N-0434]
Final Guidance on Industry-Supported Scientific and Educational
Activities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a final
guidance entitled ``Final Guidance on Industry-Supported Scientific and
Educational Activities'' (hereinafter referred to as the final
guidance). The agency sought public comment on a draft version of this
final guidance entitled ``Draft Policy Statement on Industry-Supported
Scientific and Educational Activities'' (hereinafter referred to as the
draft policy statement), which was published in the Federal Register on
November 27, 1992; and on November 18, 1994, on a related citizen
petition. The agency considered the comments received and, where
appropriate, revised the draft policy statement to create the final
guidance. The final guidance describes how industry may support
scientific and educational activities without being subject to
regulation under the Federal Food, Drug, and Cosmetic Act (the act).
The full text of the guidance is published in this document.
DATES: Written comments on the guidance may be submitted at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
For general questions about the guidance: Ilisa B. G. Bernstein,
Office of Policy (HF-23), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-3380, or via e-mail at
IBernste@oc.fda.gov;
Regarding biological products: Toni M. Stifano, Center for
Biologics Evaluation and Research (HFM-200), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via e-mail at stifano@cber.fda.gov;
Regarding medical device products: Byron L. Tart, Center for Device
Evaluation and Radiologic Health (HFZ-302), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4639, or
via e-mail at bxt@cdrh.fda.gov;
Regarding human prescription drugs: Norman A. Drezin, Center for
Drug Evaluation and Research (HFD-40), Food and Drug Administration,
5600 Fishers Lane, rm. 17B-17, Rockville, MD 20857, 301-827-2831, or
via e-mail at drezinn@cder.fda.gov;
Regarding prescription animal drugs: Edward L. Spenser, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722, or via e-mail at
espenser@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 27, 1992
(57 FR 56412), FDA published the draft policy statement. As the agency
noted in the introduction to the draft policy statement, these
activities may be subject to regulation under the labeling and
advertising provisions of the act when they provide information on FDA-
regulated products marketed by the supporting companies.
As the introduction also noted, FDA traditionally has not sought to
regulate industry-supported scientific and educational activities that
are otherwise independent and nonpromotional. Industry-supported
scientific and educational activities that are not independent and
nonpromotional are not per se illegal, but they are subject to
regulation.
FDA published the draft policy statement in response to requests
from industry for guidance in this area. Prior to publishing the draft
policy statement, the agency engaged in an extensive outreach effort
with scientific and health care professionals, industry, consumer
groups, and other Government agencies in an attempt to strike a proper
balance between the need for industry-supported dissemination of
current scientific information and the need to ensure that promotional
activities by industry meet the requirements of the law.
Recognizing the importance and delicacy of this balance, the agency
invited comments with regard to all issues raised in the draft policy
statement.
The agency received 152 comments, which included comments from
academic and organized medicine, health care professionals, industry
and trade associations, public relations and advertising firms, and
commercial continuing education providers. FDA thoroughly considered
these comments and revised the draft policy statement where
appropriate. In the Federal Register of November 18, 1994 (59 FR
59820), the agency sought comment on a citizen petition (Docket No.
92N-0434/CP1) requesting that the agency withdraw the draft policy
statement. The agency received about 60 comments in response to this
notice.
I. Highlights of the Final Guidance
In response to comments, the agency has made several revisions to
the draft policy statement. First, the draft policy statement has been
modified to clarify that it is providing guidance on what the agency
would look at in determining independence. In doing so, rather than
enumerating the elements of a written agreement, the final guidance
presents the ideas contained in the elements as factors the agency will
consider in evaluating activities and determining independence.
Additionally, the text of ``Other Factors in Determining Independence''
indicia that were listed in section II.B. of the draft policy statement
(57 FR 56412 at 56414) are now included in the factors the agency will
consider in evaluating activities and determining independence. Second,
although the final guidance has been modified to place less emphasis on
a written agreement between the supporting company and the provider,
the agency continues to believe that a written agreement is one way to
document what measures were taken by the parties to maintain the
independence of the program.
In the final guidance, only 1 of the 10 elements of the written
agreement presented in the draft policy statement remains unchanged.
The ``Statement of Purpose'' (section II.A.1. of the draft policy
statement) has been deleted because the final guidance lists the
factors the agency will consider, rather than a suggested written
agreement. The text of the ``Control of Content and Selection of
Presenters and Moderators'' (section II.A.2. of the draft policy
statement) has been modified slightly, but remains substantially
unchanged. In the ``Disclosure of Financial Relationships'' (section
II.A.3. of the draft policy statement) a factor has been added
indicating that when an activity includes discussion of unapproved
uses, there should be general disclosure of that fact. Additionally
this discussion has been renamed ``Disclosures,'' and all factors that
describe a disclosure are listed under this heading. The discussion
concerning ``Supporting Company Involvement in Content'' (section
II.A.4. of the draft policy statement) has been incorporated into the
factor concerning ``Control of Content and Selection of Presenters and
Moderators'' of the final guidance. The
[[Page 64075]]
discussion of ``Ancillary Promotional Activities'' (section II.A.5. of
the draft policy statement) has been narrowed so as to limit
promotional activities only in the room in which an activity takes
place. The discussions concerning ``Objectivity and Balance'' (section
II.A.6.), ``Limitations on Data'' (section II.A.7. of the draft policy
statement), and ``Discussion of Unapproved Uses'' (section II.A.8. of
the draft policy statement) have been deleted from the final guidance.
The ``Opportunities for Debate'' (section II.A.9. of the draft policy
statement) has been renamed ``Opportunities for Discussion'' to clarify
its intent. The ``Schedule of Activities'' discussion (section II.A.10.
of the draft policy statement) has also been deleted from the final
guidance.
Much of the draft policy statement's section entitled ``Other
Factors in Determining Independence'' appears in the final guidance,
with a few modifications. First, the discussions concerning the
``Provider'' (section II.B.1. of the draft policy statement) has been
modified slightly, deleting the statement that discussed whether
persons who are involved in promotion of a company's products may
function in the role as an independent provider. The discussion
concerning industry representatives help in logistical assistance
(section II.B.2.a. of the draft policy statement) has been deleted from
final guidance. The ``Suggestion of Presenters'' discussion (section
II.B.2.b. of the draft policy statement) has been incorporated, in
part, into the factor concerning ``Control and Content and Selection of
Presenters and Moderators'' in the final guidance. The discussion
concerning ``Focus on a Single Product'' (section II.B.3.a. of the
draft policy statement) has been incorporated into the factor entitled
``Focus of the Program'' in the final guidance. The discussions
concerning ``Multiple Performances'' (section II.B.3.b. of the draft
policy statement), ``Audience Selection'' (section II.B.4.c.),
``Dissemination'' (section II.B.5.), and ``Complaints'' (section
II.B.6.) remain substantially unchanged. The ``Gifts'' (section
II.B.4.a.) and ``Emphasis on Noneducational Activities'' (section
II.B.4.b.) discussions have been deleted from the final guidance.
Finally, the discussion concerning ``Misleading Title'' (section
II.B.4.d. of the draft policy statement) has been incorporated into the
factor concerning ``Focus of the Program'' in the final guidance.
In general, these revisions are intended to better focus the final
guidance on the agency's core concerns--that the provider develop the
subject program independent from the influence of the supporting
company, and that there is disclosure of relationships between and
among the supporting company, provider, presenters, and products
discussed that may be relevant to an assessment of the information
presented. Thus, while the number of changes may be significant, they
do not change the fundamental intent of the final guidance to
distinguish industry-supported scientific and educational activities
that are free from supporting company influence from those that are
not.
II. Summary and Responses to Comments Received
A. General Comments
1. Several comments disputed the agency's assertion that industry-
supported scientific and educational activities traditionally have been
viewed by the agency as subject to regulation under the act. They
maintained that regulation of these activities is an unwarranted
expansion of agency authority and that the agency should specifically
articulate the basis for its regulatory authority.
FDA has long regulated drugs and devices (including biological
products and animal drugs) based on the ``intended uses'' for such
products. Under section 201 of the act (21 U.S.C. 321), which defines
the terms ``drug'' and ``device,'' the intended use of an article
determines whether the article is a drug or device. In general, under
the act and the Public Health Service Act, a sponsor who wishes to
market any new drug or biological product must demonstrate to FDA that
the product is safe and effective for each of its intended uses. (See
sections 505(a) and 512(a) of the act (21 U.S.C. 355(a) and 360b(a))
and section 351 of the Public Health Service Act.) A sponsor who wishes
to market a new medical device must either demonstrate to FDA that
there is a reasonable assurance that the device is safe and effective
for each of its intended uses or that it is substantially equivalent to
(meaning, in part, that it has the same intended use as) another device
for which such a showing is not required. (See sections 510(k), 513(f)
and (i), and 515(a) of the act (21 U.S.C. 360(k), 360c(f) and (i), and
360e(a)).) The package insert or product manual (approved professional
labeling) which, for approved and/or licensed products, physically
accompanies the product, sets forth the uses for which the product has
been demonstrated to be safe and effective.
The ``intended use'' of a drug or device refers to the objective
intent of the persons legally responsible for the labeling of the
product. This intent is determined by such persons' expressions or by
the circumstances surrounding the distribution of the article
including, for example, labeling claims, advertising matter, or oral or
written statements by such persons or their representatives. (See 21
CFR 201.128 and 801.4.) The agency, thus, regulates products based not
only on information provided ``with'' the product (approved
professional labeling), but also based on information disseminated by
or on behalf of manufacturers in other contexts, such as scientific and
educational meetings and symposia, books, reprints of articles from
scientific journals, in part because all of these activities/materials
can create new intended uses for the products, which must be reflected
in the approved labeling of the products.
The agency's focus on the manufacturer's characterization of its
product in the marketplace is best reflected in the statutory
requirement that a drug or device shall be deemed to be misbranded
unless its labeling bears adequate directions for use. (See section
502(f)(1) of the act (21 U.S.C. 352(f)(1)).) The courts have agreed
with the agency that section 502(f)(1) of the act requires information
not only on how a product is to be used (e.g., dosage and
administration), but also on all the intended uses of the product. (See
Alberty Food Products Co. v. United States, 185 F.2d 321 (9th Cir.
1950) (drug product was misbranded because its labeling failed to state
the intended use of the drug (arthritis and rheumatism) as suggested by
the company in newspaper advertisements); 21 CFR 201.5)) As previously
described, oral statements and materials presented at industry-
supported scientific and educational activities may provide evidence of
a product's intended use. If these statements or materials promote a
use that is inconsistent with the product's approved labeling, the
product is misbranded under section 502(f)(1) of the act for failure to
bear labeling with adequate directions for all intended uses. If it is
a device, it is also adulterated because the listing of unapproved uses
in the labeling or advertising of an approved device results in an
adulterated medical device under section 501(f) of the act, and
misbranded under section 502(o) of the act because premarket
notification was not provided as required under section 510(k) of the
act.
FDA also finds support for its policy of examining a broad array of
information disseminated by companies in the general grant of authority
over labeling and advertisements. Section
[[Page 64076]]
201(m) of the act defines the term ``labeling'' to include all
``written, printed, or graphic'' materials ``accompanying'' a regulated
product. The Supreme Court has agreed with the agency that this
definition is not limited to materials that physically accompany a
product. If the material supplements, explains, or is otherwise
textually related to a product, it is deemed to accompany the product
for purposes of section 201(m) of the act. (See Kordel v. United
States, 335 U.S. 345 (1948).)
The agency has adopted a similar interpretation of the term
``advertisement,'' which appears in section 502(n) of the act
(prescription drug advertisements) and 502(r) of the act (restricted
device advertisements). Although the act does not define the term
``advertisement,'' section 502(n) and (r) of the act indicates that
advertisements do not include materials regulated as labeling. In
addition, the legislative histories of the 1938 act and the 1962
amendments to the act support a broad construction of what constitutes
``advertising.'' Thus, the agency interprets the term ``advertisement''
to include information (other than labeling) that originates from the
same source as the product and that is intended to supplement or
explain the product. Prescription drug and restricted device
advertisements that do not comply with section 502(n), (q), or (r) of
the act, or regulations issued thereunder, cause a prescription drug or
restricted device to be misbranded.
2. Some comments contended that the policy will adversely affect
the availability and quality of continuing education for health care
professionals. They maintained that the perception of regulatory risk
on the part of supporting companies, as well as administrative and
financial burdens resulting from compliance with the policy, will cause
companies that have supported educational programs to redirect funds to
lower risk, more efficient activities.
The agency recognizes the importance of continuing education for
health care professionals and recognizes, as well, the traditional role
of industry in supporting such activities. With this final guidance,
the agency has attempted to address concerns raised by supporting
companies, to describe factors the agency will consider in determining
whether an industry-supported activity is independent and not generally
subject to regulation, and to accommodate industry's need for
predictability in these activities. The agency believes that the
flexibility accorded companies in the final guidance and in the
agency's responses to these comments should provide a reasonable basis
for continued support for these activities. Decisions by companies
involving allocation of resources for promotion and education are, of
course, affected by a variety of factors. The agency cannot ensure that
companies will provide a given level of support for professional
education within the health care community.
B. The First Amendment
3. Several comments contended that the Draft Policy Statement on
Industry-Supported Scientific and Educational Activities (Draft Policy
Statement) infringes upon the First Amendment to the Constitution. Some
comments claimed that the Draft Policy Statement infringed protections
afforded to commercial speech.
The agency has considered the First Amendment in developing its
policies on industry-supported scientific and educational activities,
and believes that the Draft Policy Statement and the Final Guidance are
consistent with the First Amendment's protection of freedom of
expression. In producing these policy statements (guidance), FDA has
sought to accommodate the need for industry-supported scientific and
educational activities and the statutory mandate to regulate
promotional activities (labeling and advertising) for drugs and devices
in accordance with the act and the Public Health Service Act.
1. The Regulation of Drugs and Devices
FDA's guidance on industry-supported scientific and educational
activities describes the agency's regulation of drugs and medical
devices; it is not intended to regulate speech. It provides insight
into the factors FDA will consider when evaluating an industry-
supported activity to determine whether it should be subject to
regulation as labeling or advertising, and, if so, to ensure that the
activity does not misbrand or adulterate the subject drug or device.
There are three bases for this conclusion.
First, the guidance applies only to those company-supported
activities that relate to the supporting company's product(s) or to
competing product(s). A company-supported activity that does not relate
to the company's product, a competing product, or suggest a use for the
company's product would not be subject to regulation as a promotional
activity.
Second, the guidance distinguishes between company-supported
activities that are independent of the promotional influence of the
supporting company and those that are not. As explained in the
guidance, the agency does not seek to regulate industry-supported
activities that are independent and nonpromotional.
Third, the regulation of drugs and devices has an unavoidable
effect on speech. As explained more fully in response to Comment A.1,
the act mandates that FDA regulate products as drugs or devices
(including biological products and animal drugs) based on the
``intended uses'' for such products.
Under section 201 of the act which defines, among other things, the
terms ``drug'' and ``device,'' the intended use of an article
determines whether the article is a drug or device. In general, under
the act and the Public Health Service Act, a sponsor who wishes to
market any new drug or biological product must demonstrate to FDA that
the product is safe and effective for each of its intended uses
(sections 505(a) and 512(a) of the act and section 351 of the Public
Health Service Act). A sponsor who wishes to market a new medical
device must either demonstrate to FDA that there is a reasonable
assurance that the device is safe and effective for each of its
intended uses or that it is substantially equivalent to (meaning, in
part, that it has the same intended use as) another device for which
such a showing is not required (sections 510(k), 513(f) and (i), and
515(a) of the act). In addition, all drugs and devices must bear
labeling with adequate directions for each intended use. If labeling
for a drug or device fails to contain adequate directions for each
intended use, the drug or device is deemed to be misbranded (section
502(f)(1) of the act) and subject to seizure or other enforcement
actions. For approved or licensed products, the requirement that
products bear labeling with adequate directions for use is met by
inclusion of the products' FDA-approved professional labeling (package
insert or product manual) that sets forth the uses for which the
product has been approved/cleared as safe and effective.
The intended use of a drug or device refers to the objective intent
of the persons legally responsible for the labeling of the product.
The intent is determined by such persons' expressions or may be
shown by the circumstances surrounding the distribution of the
article. This objective intent may, for example, be shown by
labeling claims, advertising matter, or oral or written statements
by such persons or their representatives.
(21 CFR 201.128 and 801.4) (emphasis added); see e.g., Coyne Beahm,
Inc., et al. v. United States Food and Drug Administration, et al., 958
F. Supp. 1060 (M.D.N.C. 1997).
Accordingly, oral statements and materials presented at industry-
[[Page 64077]]
supported scientific and educational activities may provide evidence of
a product's intended use. If these statements or materials promote a
use that has not been approved by the agency (and therefore does not
appear in the product's approved labeling), the product is misbranded
under section 502(f)(1) of the Act for failure to bear labeling with
adequate directions for all intended uses (21 CFR 201.5; Alberty Food
Products Co. v. United States, 185 F.2d 321 (9th Cir. 1950)). The
product may also be misbranded if its labeling\1\ or advertising is
false or misleading (section 502(a), (n), and (q) of the act). If it is
a device, it is also adulterated because the listing of unapproved uses
in the labeling or advertising of an approved device results in an
adulterated medical device under section 501(f) of the act, and
misbranded under section 502(o) of the act because premarket
notification was not provided as required under section 510(k) of the
act.\2\ Thus, FDA's regulation of intended uses for drugs and devices
is essential to the regulation of such products. The safety and
effectiveness of drugs and devices cannot be evaluated in isolation
from consideration of their intended uses.
---------------------------------------------------------------------------
\1\ Section 201(m) of the act defines the term ``labeling'' to
include all ``written, printed, or graphic'' materials
``accompanying'' a regulated product. (See Kordel v. United States,
335 U.S. 345, 349-350 (1948).)
\2\ It is a violation of the act to, among other things,
introduce or deliver for introduction into interstate commerce a
misbranded or adulterated drug or device, or to cause the
misbranding or adulteration of a drug or device while it is held for
sale after shipment in interstate commerce. (See e.g., sections
301(a) and (k) of the act.)
---------------------------------------------------------------------------
The Supreme Court ``has recognized the strong governmental interest
in certain forms of economic regulation, even though such regulation
may have an incidental effect on rights of speech * * *'' (NAACP v.
Claiborne Hardware Co., 102 S.Ct. 3409, 3425 (1982)). (See also Ohralik
v. Ohio State Bar Association, 98 S.Ct. 1912, 1919 (1978) (the
government ``does not lose its power to regulate commercial activity
deemed harmful to the public whenever speech is a component of that
activity'').) Similarly, several lower courts have recognized that in
certain areas of extensive Federal regulation (securities, antitrust,
transportation, trade, and labor), the Government may regulate
communications of the regulated parties without offending the First
Amendment. In particular, SEC v. Wall Street Publishing Institute,
Inc., 851 F.2d 365 (D.C. Cir. 1988), cert. denied, 109 S.Ct. 1342
(1989), is most analogous to FDA's regulation of industry-supported
scientific and educational activities.
The defendant in Wall Street Publishing published a stock market
magazine that included feature articles profiling individual companies
and portraying the subject firms as appealing investment prospects.
Some of the articles were written by the featured company itself,
others were written by public relations firms paid by the featured
companies, and still others were written by the editors of the
magazine, who were paid by the featured companies. Because these
arrangements were not disclosed in the magazine, the Securities
Exchange Commission (SEC) sought to enjoin the publisher for violations
of section 17(b) of the Securities Act of 1993, 15 U.S.C. 77q(b), which
makes it unlawful to describe a security for consideration without
disclosing the existence of the consideration. The publisher challenged
the injunction on, among others, First Amendment grounds.
The court rejected the SEC's characterization of the feature
articles as commercial speech and upheld the government's efforts to
regulate the magazine based on ``the federal government's broad powers
to regulate the security industry'' (Id. at 372 (footnote omitted)).
According to the court, ``[w]here the federal government extensively
regulates a field of economic activity, communication of the regulated
parties often bears directly on the particular economic objectives
sought by the government, and regulation of such communications has
been upheld'' (Id. (citations omitted)). This holding stems from the
fact that ``[i]f speech employed directly or indirectly to sell
securities were totally protected, any regulation of the securities
market would be infeasible* * *.'' (Id. at 373; see also Id. at 374 n.9
(``Requiring disclosure of a material fact in order to prevent investor
misunderstanding is the very essence of federal securities
regulation.''))
The court noted that:
[R]egulation of the exchange of information regarding securities
is subject only to limited First Amendment scrutiny. Speech relating
to the purchase and sale of securities, in our view, forms a
distinct category of communications in which the government's power
to regulate is at least as broad as with respect to the general
rubric of commercial speech * * * In areas of extensive federal
regulation * * * we do not believe the Constitution requires the
judiciary to weigh the relative merits of particular regulatory
objectives that impinge upon communications occurring within the
umbrella of an overall regulatory scheme.
Id. at 373. See also Home Box Office, Inc. v. FCC, 567 F.2d 9, 46 (D.C.
Cir. 1977), cert. denied, 434 U.S. 829 (1977) (``[R]ules restricting
speech do not necessarily abridge freedom of speech.''); SEC v. Suter,
732 F.2d 1294 (7th Cir. 1984).
As with securities regulation, the Federal Government exerts
extensive authority over the sale and promotion of drugs and devices.
Moreover, as previously explained, the Government's ability to regulate
speech about these products, like its need to regulate speech
concerning the sale of securities, is essential to the regulation of
drugs and devices. Yet the regulation of drugs and devices, unlike the
regulation of securities, clearly encompasses more than economic
activity; it protects consumer health and safety in an area where harm
to the public can be direct and immediate.
Accordingly, First Amendment defenses have been raised and rejected
in a number of FDA enforcement actions. ``Freedom of speech does not
include the freedom to violate the labeling provisions of the Federal
Food, Drug, and Cosmetic Act'' (United States v. Articles of Food * * *
Clover Club Potato Chips, 67 F.R.D. 419, 424 (D. Idaho 1975)). The
First Amendment does not prohibit the seizure and condemnation of a
book that is used to misbrand a product (United States v. 8 Cartons,
Containing ``Plantation 'The Original' etc. Molasses'', 103 F. Supp.
626, 628 (W.D.N.Y. 1951); United States v. Articles of Drug, 32 F.R.D.
32, 35 (S.D. Ill. 1963); but cf. United States v. 24 Bottles * *
*''Sterling Vinegar and Honey'', 338 F.2d 157 (2d Cir. 1964) (book not
used in immediate connection with sale of product is not labeling and
does not misbrand product)).
In conclusion, the act requires that FDA regulate drugs and devices
based on their ``intended use.'' The term ``intended use'' is broadly
defined to capture the manner in which a company characterizes its
product in the marketplace. The agency thus must examine the various
means by which manufacturers and their representatives provide
information about their products to health care professionals and
consumers, including statements and materials presented at industry-
supported scientific and educational activities, to determine whether
the products are being improperly promoted, and therefore misbranded or
adulterated. Accordingly, FDA's ability to regulate the communications
at such activities is essential to the regulation of drugs and devices.
In view of the fact that the regulation of drugs and devices is an area
of extensive federal regulation, the agency may regulate the
communications at industry-supported
[[Page 64078]]
scientific and educational activities without violating the First
Amendment.
2. Commercial Speech
Assuming, contrary to the analysis just presented, that industry-
supported scientific and educational activities constitute protected
speech, they are commercial speech and FDA's regulation of such
activities does not violate the First Amendment. Although the Supreme
Court has furnished little explicit guidance as to how to determine
whether speech is commercial, it has provided some suggestion as to
what factors are relevant when making a commercial speech
determination. (See Bolger v. Youngs Drug Products), 103 S.Ct. 2875
(1983) (concluding that informational pamphlets are commercial speech
based on a combination of three characteristics (conceded to be
advertisements, reference to a specific product, and economic
motivation), but not suggesting that each of these characteristics is a
necessary element of commercial speech); S.U.N.Y. v. Fox, 109 S.Ct.
3028 (1989) (speech which proposes a commercial transaction);
Cincinnati v. Discovery Network, 113 S.Ct. 1505 (1993) (speech which
proposes a commercial transaction).) Furthermore, the Court has made
clear that speech which does more than propose a commercial transaction
(linking a product to a current public debate or containing discussions
of important public issues) is not necessarily transformed into
noncommercial speech (Central Hudson Gas & Electric Corp. v. Public
Serv. Comm'n, 100 S.Ct. 2343 (1980); Bolger, 103 S.Ct. at 2880-2881).
Applying the characteristics suggested in Bolger (advertisement,
reference to a specific product, economic motivation) or the test used
in Fox and Discovery Network (speech which proposes a commercial
transaction), industry-supported scientific and educational activities
are commercial speech. The guidance at issue only applies to activities
that make reference to a specific product, and as explained below, the
activities are economically motivated and propose a commercial
transaction. Drug and device companies sponsor such programs not only
to encourage scientific exchange, education, and corporate goodwill,
but more importantly, to convince the audience to prescribe, purchase,
or otherwise use the products mentioned. A company-sponsored program
that discusses use of a company product carries with it, at the least,
an implicit solicitation, and in many cases an explicit one (cf.
Central Hudson, 100 S.Ct. at 2352 (suggesting that most businesses are
unlikely to underwrite promotions that are of no interest to
consumers); National Commission on Egg Nutrition v. FTC, 570 F.2d 157
(7th Cir. 1977) (advertisement by egg industry trade association
claiming no relationship between eggs, cholesterol, and heart disease
constitutes commercial speech)).
Indeed, a review of the medical literature on industry-supported
scientific and educational activities demonstrates that such activities
are economically motivated and propose a commercial transaction. It is
significant to note that the number and cost of drug company-supported
symposia have increased significantly over the years. In 1974, 16 drug
companies sponsored 7,519 symposia, at a cost of 6.5 million dollars.
Roughly comparable figures showed that in 1988 the same companies
sponsored 34,688 symposia at a cost exceeding 85.9 million dollars.\3\
It is reasonable to conclude that drug companies would not spend such
large sums of money if they did not view these programs as an effective
means to promote their products. Numerous reports in the medical
literature support this conclusion.
---------------------------------------------------------------------------
\3\ Senate Labor and Human Resources Committee, Congressional
Research Service, Survey of selected pharmaceutical firms,
Washington, DC, Government Printing Office, 1991.
---------------------------------------------------------------------------
In an article entitled ``Physicians and the Pharmaceutical
Industry: An Alliance with Unhealthy Aspects,'' 36 Perspectives in
Biology and Medicine 376-394, 385 (Spring 1993), author Robert C. Noble
describes industry-sponsored symposia as, ``an effective method for
marketing new drugs,'' and explains that, ``[t]he symposium, like the
promotional dinner, is frequently given a neutral title that disguises
any promotional purpose * * *'' (emphasis added). (See also Lisa Bero,
Alison Galbraith, and Drummond Rennie, ``The Publication of Sponsored
Symposiums in Medical Journals,'' New England Journal of Medicine,
327:1135-1140, 1992 (demonstrating that published symposia were
promotional and not peer-reviewed, and those that were sponsored by a
single company focused on single products, had misleading titles, and
featured unapproved drugs).)
It has also been suggested that drug companies will not provide
financial support for scientific and educational activities unless
those activities in some way promote the supporting company's products.
An editorial by Stephen E. Goldfinger, in the New England Journal of
Medicine, addressed the growing support and influence of the drug
industry in the education of physicians. According to Dr. Goldfinger:
The most acceptable kind of educational backing is the least
available: donations to providers of continuing medical education
that are unrestricted with respect to program topics, speakers, or
the backgrounds of the invited registrants. When I have suggested
this model to pharmaceutical directors who proclaim a genuine
interest in supporting continuing medical education, the usual
response is a quizzical smile followed by a gentle reminder of the
value of confining our discussion to the realm of the possible. At a
minimum, that realm usually requires the topic to be an area ``of
interest'' to the sponsor, meaning an area related to a product line
in need of promotion.
Stephen E. Goldfinger, ``A Matter of Influence'' (Editorial), New
England Journal of Medicine, pp. 1408-1409, 1409 (May 28, 1987).
Similarly, 2 years later, Eugene M. Bricker, wrote in the same journal
that:
Most of the medical-service industry's marketing exercises are
intended to be both educational and promotional, and some are indeed
broadly educational and of excellent quality. This does not alter
the fact that promotion is their basic objective; companies would
not subsidize marketing methods unless they were rewarding.
Eugene M. Bricker, ``Industrial Marketing and Medical Ethics''
(Editorial), New England Journal of Medicine, pp. 1690-1692, 1691 (June
22, 1989). (See also Kenneth Miller, William A. Gouveia, Michael Barza,
et al., ``Undesirable Marketing Practices in the Pharmaceutical
Industry'' (Letter to the Editor), New England Journal of Medicine, p.
54 (July 4, 1985) (Physician and pharmacist members of a hospital
pharmacy committee expressing concern that drug company grants to
support educational functions, such as talks by visiting speakers, are
sometimes clearly linked to a request for the admission of a drug to
the hospital's formulary or increased use of the product).)
Moreover, the results of a study by Marjorie A. Bowman and David L.
Pearle, ``Changes in Drug Prescribing Patterns Related to Commercial
Company Funding of Continuing Medical Education,'' Journal of
Continuing Education in the Health Professions, 8:13-20, 1988, confirm
that industry-supported scientific and educational activities propose a
commercial transaction. Doctors Bowman and Pearle analyzed the drug
prescribing patterns of physicians attending three different continuing
medical education (CME) courses, each of which was subsidized heavily
by a single, but different drug company. The course topics were
directly related to a set of similar drugs from the same class.
Immediately prior to and 6 months after
[[Page 64079]]
each course, the physician attendees were asked to identify the
frequency of prescriptions written for the set of drugs. Despite the
presumed independence of CME course content, in all three courses the
rate of prescribing for the drug of the sponsoring company increased
the greatest in absolute terms, while prescribing rates for the other
drugs discussed in the program either decreased or did not increase as
much. Thus, company funding of such programs does appear to influence
physicians' drug prescribing behavior in favor of the sponsoring
company's product. (See also Jerry Avorn, Milton Chen, and Robert
Hartley, ``Scientific and Commercial Sources of Influence on the
Prescribing Behavior of Physicians,'' American Journal of Medicine,
73:4-8, 1982 (demonstrating that commercial sources have greater
influence over prescribing behavior than scientific sources of
information); Robert S. Stern, ``Drug Promotion for an Unlabeled
Indication--The Case of Topical Tretinoin,'' New England Journal of
Medicine,'' 331:1348-1349, 1994 (demonstrating that reports of company-
sponsored studies and promotional efforts, including symposia, were
associated with a large increase in prescribing for an unapproved
indication).)
Thus, if industry-supported scientific and educational activities
constitute protected speech, that speech is ``commercial speech'' for
purposes of constitutional analysis.
3. The Central Hudson Analysis
Over the past few decades, the Supreme Court has afforded
commercial speech limited constitutional protection (Virginia State
Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 96 S.Ct.
1817 (1976); Central Hudson, 100 S.Ct. at 2343; 44 Liquormart, Inc. v.
Rhode Island, 116 S.Ct. 1496 (1996)). In Central Hudson, the Supreme
Court established a four-prong test to determine whether limitations on
commercial speech are constitutional. The test inquires: (1) Whether
the speech concerns lawful activity and is not misleading; (2) whether
the asserted government interest is substantial; (3) whether the
limitation directly advances the governmental interest asserted; and
(4) whether the limitation is not more extensive than is necessary to
serve that interest (Central Hudson, 100 S.Ct. at 2351). Subsequently,
in S.U.N.Y. v. Fox, 109 S.Ct. 3028 (1989), the Court clarified that the
fourth prong of the Central Hudson test is not a ``least restrictive
means'' requirement; rather it requires that the restriction be
``narrowly tailored'' to serve the asserted government interest. Narrow
tailoring means ``a fit that is not necessarily perfect, but
reasonable'' between means and ends (Id. at 3035).
FDA's guidance on industry-supported scientific and educational
activities satisfies all four prongs of the Central Hudson test.
a. The first prong. Commercial speech that is false or misleading,
or that concerns illegal activity, is not protected by the First
Amendment and may be banned (Zauderer v. Office of Disciplinary
Counsel, 105 S.Ct. 2265, 2275 (1985); Ibanez v. Board of Accountancy,
114 S.Ct. 2084, 2088 (1994)). Commercial speech is misleading when it
is either inherently likely to deceive or when experience has shown
that the speech has in fact been deceptive (In Re R.M.J., 102 S.Ct.
929, 937 (1982)). Regulation of commercial speech that is not
misleading, or that is only potentially misleading, must satisfy the
remaining prongs of the Central Hudson test.
As previously discussed, industry-supported scientific and
educational activities that promote an unapproved product, or promote
an approved product for an unapproved use, create an unlawful product--
a misbranded or adulterated drug or device. Accordingly, industry-
supported activities that promote unlawful products ``concern illegal
activity'' and may be prohibited.
Although FDA believes that most industry-supported scientific and
educational activities are not inherently misleading, they are clearly
potentially misleading. The potential to mislead the listener (a health
care professional) at such an activity is heightened because the
listener must not only determine whether the information presented is
scientifically sound, but also whether, or to what extent, the
supporting company has influenced the presentation.
Evidence of bias in the content of industry-supported CME programs
was demonstrated in a study conducted by Marjorie A. Bowman. Dr. Bowman
analyzed the content of two CME programs on calcium channel blocker
drugs (approved for treating high blood pressure) that were funded by
different drug companies. In each case, the program speakers mentioned
positive effects more often in connection with the sponsoring company's
drug and negative effects more often with competitors' drugs.\4\ A
second study that analyzed the publication of industry-sponsored
symposia in medical journals concluded that the symposia were
promotional in nature and not peer-reviewed, and those that were
sponsored by single pharmaceutical companies focused on single drug
products, had misleading titles, and featured unapproved drugs.\5\
Additionally, there are numerous reports in the medical literature
describing deceptive practices in the design and delivery of industry-
supported symposia. See e.g., Robert C. Noble, ``Physicians and the
Pharmaceutical Industry: An Alliance with Unhealthy Aspects,'' 36
Perspectives in Biology and Medicine 376-394 (Spring 1993); ``Pushing
Drugs to Doctors,'' Consumer Reports, 57:87, Feb. 1992 (reporting on
drug industry marketing practices that mislead doctors).
---------------------------------------------------------------------------
\4\ Marjorie A. Bowman, ``The Impact of Drug Company Funding on
the Content of Continuing Medical Education,''Mobius, 6:66-69,
January 1986.
\5\ Lisa Bero, Alison Galbraith, and Drummond Rennie, ``The
Publication of Sponsored Symposiums in Medical Journals,''New
England Journal of Medicine, 327:1135-1140, 1992.
---------------------------------------------------------------------------
The potential to present misleading information at industry-
supported activities is a particular concern when unapproved uses are
addressed. Usually, unapproved uses have not been vigorously evaluated,
or if they have been studied, the results are inconclusive. Thus,
unapproved uses tend to lack the same degree of certainty and
confidence as FDA approved uses. In fact, the data that can identify
risks associated with the unapproved use often do not exist, and
therefore complete information about the risks of the new use cannot be
provided. This lack of data, of course, does not make all discussions
about unapproved uses misleading. However, it is important that the
audience understand the limitations on data supporting unapproved uses.
The disclosure of such limitations, as recommended in the Final
Guidance, will help ensure that the audience understands the
uncertainty associated with unapproved uses and not be misled into
thinking that such uses are safe and effective.
b. The second prong. FDA's guidance on industry-supported
scientific and educational activities serves the substantial Government
interest of protecting the health and safety of its citizens by helping
to ensure the dissemination of truthful and nonmisleading information
about drugs and medical devices. The Supreme Court has repeatedly held
that the Government's ``interest in the health, safety, and welfare of
its citizens constitutes a substantial interest'' (Posadas de Puerto
Rico Associates v. Tourism Co., 106 S.Ct. 2968, 2977
[[Page 64080]]
(1986); Rubin v. Coors, 115 S.Ct. 1585, 1591 (1995)).
In order to protect and promote the public health, Congress granted
FDA broad statutory authority to ensure that promotional activities
(labeling and advertising) for drugs and devices are truthful and not
misleading. Section 502(a) of the act provides that a drug or device is
deemed to be misbranded if its labeling is false or misleading in any
particular, and under section 502(q) of the act a restricted medical
device is misbranded if its advertising is false or misleading in any
particular. A prescription drug is misbranded under section 502(n) of
the act unless the manufacturer, packer, or distributor includes in all
advertisements with respect to that drug, ``a true statement of * * *
information in brief summary relating to side effects,
contraindications, and effectiveness * * *.''\6\ Similarly, a
restricted device is misbranded under section 502(r) of the act unless
the manufacturer, packer, or distributor includes in all advertisements
with respect to that device, ``a true statement of * * * the intended
uses of the device and relevant warnings, precautions, side effects,
and contraindications * * *.'' Moreover, section 201(n) of the act
specifically explains that if an article is alleged to be misbranded
because the labeling or advertising is misleading, there shall be taken
into account not only representations or suggestions made in the
labeling or advertising, but also the extent to which the labeling or
advertising fails to reveal material facts. The dissemination of false
or misleading information about drugs and devices can induce physicians
to choose therapies that deprive patients of reliable treatment and
cause severe morbidity, life-threatening adverse effects, or death.
---------------------------------------------------------------------------
\6\ The prescription drug advertising regulations, issued under
section 502(n) of the act, provide that an advertisement does not
satisfy the requirement that it present a ``true statement'' of
information in brief summary if it is false or misleading with
respect to side effects, contraindications, or effectiveness (see 21
CFR 202.1(e)(5)(i)). In addition, the regulations list 33 ways in
which prescription drug advertisements may be false or misleading
(see 21 CFR 202.1(e)(6) and (e)(7)).
---------------------------------------------------------------------------
FDA's guidance also serves to protect the public health by
preserving the integrity of the premarket approval process, a second
substantial government interest. As explained earlier, by enacting the
act, Congress established a premarket approval and clearance process
whereby manufacturers must establish that their drugs and devices are
safe and effective for each of their intended uses before they can be
marketed and promoted for those uses. Manufacturers of drugs and
devices are not permitted to promote unapproved products or unapproved
uses of approved products, either directly or indirectly, such as
through industry-supported scientific and educational activities. This
regulatory requirement is an important incentive for manufacturers to
conduct studies to determine whether their products are safe and
effective. If premarket approval were not required for each intended
use and manufacturers were free to promote products for any use,
manufacturers would have little reason to do scientific research and to
present their data to FDA. Additionally, it is important to note that
the approval of a drug or device for one use does not provide assurance
that the product is safe or effective for a different use or use in a
different patient population. Consequently, the promotion of unapproved
uses raises significant safety concerns, which are more fully discussed
below.
c. The third prong. FDA's guidance on industry-supported scientific
and educational activities directly advances the government's
substantial interests. ``[A] governmental body seeking to sustain a
restriction on commercial speech must demonstrate that the harms it
recites are real and that its restriction will in fact alleviate them
to a material degree'' (Edenfield v. Fane, 113 S.Ct. 1792, 1800
(1993)).
FDA's guidance directly advances the Government's interest of
protecting the health and safety of its citizens by helping to ensure
the dissemination of truthful and nonmisleading information about drugs
and devices. The guidance includes a number of suggestions on the
design and conduct of industry-supported scientific and educational
activities so that they will be free from the promotional influence of
the supporting company and not misleading. Such suggestions include,
for example, meaningful disclosure of the company's funding of the
program and any significant relationship between the provider (an
entity, other than a regulated company, that produces the activity or
program), presenter, and supporting company; giving the provider full
control over the content of the program and selection of speakers;
avoiding involvement of the sales or marketing departments of the
supporting company in audience selection decisions; and not having
promotional activities in the meeting room. Industry-supported
activities that are designed and carried out in this manner are less
likely to result in the dissemination of false, misleading, or biased
information that can adversely affect public health.
On a number of occasions, FDA has become aware of and taken action
against industry-supported scientific and educational activities that
were false or misleading, and that could have caused harm to patients.
For example, a few years ago, agency staff viewed two videotaped
presentations on treating gallstone disease that were broadcast
nationwide on a cable television network intended for physicians. The
videos were produced and paid for by a major drug company and
prominently featured a drug marketed by the company for the chemical
dissolution of certain gallstones. The programs encouraged doctors to
prescribe this drug instead of surgery to treat gallstone disease.
These representations and suggestions were false or misleading because:
(1) The drug is approved only for dissolving certain types and sizes of
gallstones in patients for whom surgery is not medically appropriate,
or for patients who refuse surgery, and (2) surgery is more effective
and is the preferred treatment for almost all patients with gallstone
disease.
These industry-sponsored presentations could have caused many
physicians to make inappropriate and potentially harmful treatment
decisions. After FDA notified the sponsoring company that the programs
were false or misleading, the company agreed to take appropriate
corrective action.
In a more recent example, a major drug company sponsored a
misleading symposium on cyclosporine drug products (approved to prevent
organ rejection in kidney, liver, and heart transplant patients), held
in conjunction with the annual meeting of the American Society of
Transplant Physicians. The sponsoring company's ``pioneer''
(nongeneric) cyclosporine drug product was about to lose patent
protection and face competition from lower-priced generic cyclosporine
products at the time of the symposium.
An investigation by FDA revealed that the sponsoring company and
its agent specifically requested that one invited speaker revise his
abstract to remove any references to the impending availability of
generic cyclosporine products, to delete or revise sections of text
that did not support switching stable patients to the sponsoring
company's product, and to make other revisions to his presentation.
Despite the speaker's insistence on including his abstract as
originally written, the sponsoring company again asked the speaker to
revise his abstract and presentation. When the speaker again refused to
revise his abstract, it was not
[[Page 64081]]
included in the program materials disseminated during the symposium.
The sponsoring company's actions to control the content of the
symposium resulted in a misleading presentation in that: (1) The
sponsoring company implied that the speakers were speaking without
editorial input or influence from the sponsoring company, and (2) the
sponsoring company foreclosed a full discussion of all cyclosporine
drug products. The sponsoring company's efforts undermined the unbiased
exchange of scientific information, may have caused physicians to
unnecessarily switch stable patients to the company's product, and
likely resulted in greater than necessary expenditures by patients.
This might not have been the case had the sponsoring company,
consistent with the agency's longstanding policy as articulated in the
Draft Policy Statement, not influenced the content of the program.
FDA's guidance also directly advances the Government's interest of
protecting the public health by preserving the integrity of the
premarket approval process. The act requires sponsors to establish that
their drugs and devices are safe and effective for their intended uses
before they can be marketed and promoted. Consistent with this
statutory scheme, FDA has consistently prohibited the promotion of
unapproved products and unapproved uses of approved products. As
explained earlier, this preserves the incentive for sponsors to conduct
the adequate and well-controlled clinical investigations that are
necessary to demonstrate whether products are safe and effective for
each of their intended uses, and prevents patients from being exposed
to unnecessary harms. There are, unfortunately, several examples of
harms associated with the promotion of unapproved uses.
For example, several manufacturers of calcium channel blockers
(drugs approved to treat a type of chest pain known as angina)
attempted to promote these products for use in patients who had
recently suffered heart attacks, called acute myocardial infarctions
(post-AMI patients). The use of calcium channel blockers in post-AMI
patients is not an approved use, and the agency successfully thwarted
these promotional efforts. Many studies of post-AMI calcium channel
blocker use have failed to show benefits, and some studies suggest that
they may cause harm, particularly in patients with poor heart function.
Given the many patients who suffer an AMI each year, the loss of life
could have been in the thousands if the manufacturers had promoted this
use.
In another example, certain approved anti-arrhythmic drugs were
illegally promoted for unapproved uses in post-AMI patients. Included
in these promotional activities were industry-sponsored lectures,
presentations, and other publicity events. Use of anti-arrhythmic drugs
for this unapproved use was substantial and growing until a clinical
study (the CAST study) was conducted to evaluate definitively the
safety and effectiveness of this use. The study produced a highly
unexpected result in that the treatment with anti-arrhythmic drugs
produced a 2.5-fold increase in mortality. It is estimated that tens of
thousands of deaths were associated with this unapproved use.\7\
---------------------------------------------------------------------------
\7\ More Information for Better Patient Care: Hearing on S. 1477
Before the Senate Comm. on Labor and Human Resources, 104th Cong.
51, 78-79 (1996) (statement of Thomas J. Moore, Senior Fellow,
Center for Health Policy Research, George Washington University).
---------------------------------------------------------------------------
More detailed information on the preceding examples and additional
examples involving drugs, biologics, and devices are contained in an
FDA Federal Register notice requesting comments on a citizen petition
submitted by the Washington Legal Foundation (see 59 FR 59820, November
18, 1994).
FDA's guidance on industry-supported scientific and educational
activities protects the integrity of the premarket approval process
because it dissuades manufacturers from using such activities as a
means to promote unapproved products and unapproved uses; thereby
encouraging scientific research and eliminating unnecessary harms to
patients. At the same time, however, the agency acknowledges that drug
and device manufacturers have an important role in legitimate
scientific and educational discussions, including discussions of
unapproved products and unapproved uses. Accordingly, the guidance
recognizes that discussions of unapproved uses at industry-sponsored
activities may be appropriate, and suggests that the provider include a
general disclosure to the audience as to whether any unapproved uses
will be discussed. This disclosure accommodates the need for industry-
supported discussion on unapproved uses, yet helps ensure that the
information presented is not misleading so as to be misconstrued as
discussion of an approved use.
d. The fourth prong. The agency believes that the guidance is
``narrowly tailored'' and a reasonable approach to protect the health
and safety of consumers by discouraging the dissemination of misleading
or biased information, and by maintaining the integrity of the
premarket approval process. The ``Factors Considered in Evaluating
Activities and Determining Independence,'' in section II.A. of the
Final Guidance, are ``reasonable means'' of distinguishing industry-
supported activities that are intended to be promotional from those
that are intended to be nonpromotional and free from the supporting
company's influence and bias.
The Supreme Court has expressed a willingness to defer the fourth-
prong determination to the regulating body. (See Fox, 109 S.Ct. at
3035; United States v. Edge Broadcasting Co., 113 S.Ct. 2696, 2707
(1993).) Since Fox, the Court has applied the ``reasonable fit''
standard to uphold the regulation of commercial speech. (See Edge, 113
S.Ct. at 2705; Florida Bar v. Went For It, Inc., 115 S.Ct. 2371, 2380
(1995).) Moreover, the courts have granted greater leeway and upheld
reasonable regulation of commercial speech with regard to potentially
harmful activities. (See Edge, 113 S.Ct. 2696 (upholding Federal
prohibition of lottery advertising on radio in nonlottery State);
Anheuser-Busch, Inc. v. Schmoke, 63 F.3d 1305 (4th Cir. 1995), cert.
denied, 65 U.S.L.W. 3723 (April 28, 1997) (No. 96-1428) (upholding
restrictions on outdoor advertising of alcoholic beverages); Penn
Advertising of Baltimore, Inc. v. Mayor and City Council of Baltimore,
63 F.3d 1318 (4th Cir. 1995), cert. denied, 65 U.S.L.W. 3723 (April 28,
1997) (No. 96-1428) (upholding restrictions on outdoor advertising of
cigarettes).) Certainly, with regard to the regulation of potentially
dangerous drugs and medical devices, FDA is entitled to the same, if
not greater, deference.
FDA's guidance on industry-supported scientific and educational
activities is narrowly tailored. The guidance applies only to those
industry-supported activities that relate to the supporting-company's
product(s) or to competing product(s). It is directed to the regulated
sponsors of such activities (drug and device manufacturers) rather than
the participating professionals. It does not apply at all to
independent scientists and organizations (e.g., universities, medical
societies, professional groups), which may freely participate in or
sponsor scientific or educational activities. Additionally, the agency
has made clear that it does not seek to regulate all industry-supported
scientific and educational activities under the labeling and
advertising provisions of the Act. As explained in the guidance, FDA
has not regulated and does not intend to regulate industry-supported
activities that are
[[Page 64082]]
independent of the promotional influence of the supporting company.
The Final Guidance suggests that the provider ensure:
[M]eaningful disclosure, at the time of the program, to the
audience of: (1) the company's funding of the program; (2) any
significant relationship between the provider, presenters or
moderators, and the supporting company (e.g., employee, grant
recipient, owner of significant interest or stock); and (3) whether
any unapproved uses of products will be discussed.
These disclosures are fully consistent with the First Amendment. (See
Virginia Board of Pharmacy, 96 S.Ct. at 1830 n. 24 (``They may also
make it appropriate to require that a commercial message appear in such
a form, or include such additional information, warnings, and
disclaimers, as are necessary to prevent its being deceptive.''); In Re
R.M.J., 102 S.Ct. at 926 (``a warning or disclaimer might be
appropriately required * * * in order to dissipate the possibility of
consumer confusion or deception.''); Zauderer, 105 S.Ct at 2282 and
n.14 (holding that disclosure requirements do not violate the First
Amendment as long as they are reasonably related to the state's
interest in preventing deception, and indicating that disclosure
requirements are one of the acceptable less restrictive alternatives to
actual suppression of speech).)
The agency's suggested disclosures are reasonably related to
ensuring that the audience is in a position to fully evaluate the
information presented, in order to avoid being misled, confused, or
deceived. The guidance suggests that the disclosures be ``meaningful''
and ``to the audience.'' It does not specify how or when during the
activity the disclosures should be delivered, or what should be said.
Furthermore, as explained previously, the guidance suggests that the
provider disclose whether any unapproved uses of products will be
discussed. It recognizes that discussions of unapproved uses may be
appropriate.
Finally, in response to comments, the agency made revisions to the
Draft Policy Statement (reflected in the Final Guidance) that are
additional evidence of ``narrow-tailoring.'' The most significant
change was to place less emphasis on the elements of a written
agreement between the supporting company and the provider, and instead
provide guidance on what the agency will consider in evaluating
activities and determining independence (Factors Considered in
Evaluating Activities and Determining Independence). The Final Guidance
makes clear that the list of factors is not exhaustive and that other
factors may be appropriate for consideration in a particular case. The
supporting company and the provider are free to adopt alternative
approaches to help ensure that activities are independent and
nonpromotional.
4. Conclusion
FDA strongly believes that the Draft Policy Statement and the Final
Guidance on Industry-Supported Scientific and Educational Activities do
not abridge the First Amendment because the agency's ability to
regulate such activities is essential to the regulation of drugs and
devices, and the regulation of drugs and devices is an area of
extensive Federal regulation. If however, such activities are
considered protected speech, they are commercial speech. The guidance
satisfies all prongs of the Central-Hudson test, and thus, does not
violate the First Amendment.
C. Scope
4. Several comments from the medical device industry argued that
medical devices should be exempt from the policy. Some comments
recommended, in the alternative, that there be a separate policy
specific to medical devices. They argued that the policy initiative
resulted from an effort to address abuses in the pharmaceutical
industry, and that such abuses are not characteristic of the
educational programs supported by medical device companies. Moreover,
they maintained that educational programs for devices are more in the
nature of hands-on training programs and thus present unique issues
that would make compliance with a number of provisions of the draft
policy statement (e.g., multiple presentations, audience selection)
impractical or impossible.
The agency declines to exempt medical devices from the final
guidance. The statutory concepts of labeling, advertising, and intended
use do not differ for drugs and medical devices. ``Hands-on'' training
sessions sponsored by device manufacturers are inherently product-
specific and generally do not fall within the description of
independent and nonpromotional educational programs that are
contemplated by the final guidance. Training provided or supported by
device manufacturers related to labeled uses would present no
difficulty for the sponsor. Industry-supported training for off-label
uses, however, will ordinarily be viewed by the agency as violative of
the act.
5. Several comments from the animal drug industry and the
veterinary community contended that animal drugs should be exempt from
the policy. They argued that the animal drug industry is not prone to
the same abuses as the human drug industry, that the process by which
continuing education programs are provided to veterinarians is not
comparable to the process by which continuing education is provided to
other health care professionals, and that the administrative burdens
and resulting expense imposed by the policy would restrict the
availability of educational programs for veterinarians.
The agency acknowledges that the processes by which continuing
education is provided for veterinary health care professionals differs
in many ways from continuing education for other health care
professionals. Nevertheless, the basic principles embodied in the final
guidance, the importance of independence, disclosure, and educational
design and intent apply to veterinary continuing medical education just
as they apply to other industry-sponsored professional education.
6. Several comments addressed the scope of activities that are
affected by the policy. Some comments contended that the scope of the
policy has been appropriately narrowed to scientific and educational
activities directed to health care professionals. They supported the
exclusion of activities directed at business, policy, or other
nonhealth care professional groups. Other comments argued that the
scope should be narrowed further to encompass only those industry-
supported educational activities directed to health care professionals
who are involved in prescribing or administering regulated products.
Several comments expressed concern that the scope of activities to
which the policy applies, beyond live presentations, is unclear. They
expressed concern about the extent to which the policy applies to
presentations in electronic and other media. They contended that the
policy should set forth the limitations of its application and,
moreover, should expressly exempt written materials from the scope of
its application.
Although this final guidance is intended to address industry-
supported scientific and educational activities directed to health care
professionals, the agency anticipates that presentations to other
audiences may lend themselves to the principles described in this final
guidance. It is understood that a large majority of health care
professionals participate in the diagnostic and therapeutic management
of patients and are, therefore, in a position to either prescribe,
influence prescribing, or monitor the effectiveness of regulated
medical products. Information
[[Page 64083]]
presented at continuing education programs may have a significant
impact on these health care professionals.
There is no basis for applying a substantially different policy to
industry-supported educational or scientific activities that are
broadcast, electronically recorded, or disseminated via other emerging
media.
7. One comment requested that the agency clarify that the policy
applies generally to continuing medical education and also to industry-
supported educational activities directed to health care professionals.
The comment was concerned that the reference to continuing medical
education, in the first sentence of the first paragraph of the
background section of the draft policy statement, suggests that the
scope of the policy may be limited to continuing medical education.
The agency agrees with the comment and has revised the language to
refer to ``continuing education for health care professionals.''
8. One comment was concerned that the language in the background
section of the draft policy statement implies that only independent
activities, as described in the draft policy statement, can be
considered educational activities. The comment stated that accredited
educational activities that are not free from company influence, yet
not inconsistent with approved labeling for any company product
discussed, will no longer be regarded as legitimate educational
activities.
The final guidance is not intended to distinguish between education
and promotion and does not suggest that company influenced activities
are illegitimate or noneducational. To clarify this intent, FDA has
added a sentence to the background section, which states that the
agency recognizes that industry-supported activities can be both
nonpromotional and educational. The final guidance is intended to
distinguish between industry-supported activities that the agency does
not intend to regulate because they are otherwise independent of
company influence and those that are subject to regulation because of
the substantive influence of the supporting company. Company-influenced
activities that provide information to health care professionals on
regulated products may be educational in nature. They are,
nevertheless, subject to regulation and, thus, must be consistent with
approved labeling.
9. Some comments were concerned that the policy narrows or
eliminates the ability of companies to engage in scientific exchange as
provided for in Sec. 312.7(a) (21 CFR 312.7(a)) (human drugs) and
Sec. 511.1(b)(8)(iv) (21 CFR 511.1(b)(8)(iv)) (animal drugs). The
comments contended that the draft policy statement seems to subject
company-controlled scientific exchange to regulation because it is not
an independent activity. They contended that appropriate company-
controlled scientific exchange should be expressly exempted from
regulation in the policy.
This final guidance seeks to clarify the distinction between the
concepts of promotion/commercialization and industry-supported
scientific exchange set forth in Secs. 312.7(a) (human drugs) and
511.1(b)(8)(iv) (animal drugs). Programs supported by companies that
are not otherwise independent scientific or educational activities are
subject to regulation as product promotion/commercialization.
10. Several comments contended that the policy is fundamentally
flawed in that it institutionalizes industry support for continuing
education activities for health care professionals. One comment argued
that part of the definition of continuing medical education should be
that it is nonsubsidized. Other comments recommended that the agency
encourage multiple-source funding for educational activities to
minimize the potential for bias as the policy may not be adequate to
prevent the subtle bias inherent in a single sponsor situation.
The ``institutionalization'' of industry support for continuing
education predates the agency's draft policy statement. The agency has
sought to avoid, through its policy, undue interference with the
availability of continuing education. Although FDA shares the concerns
of some health care professionals that substantial reliance on industry
funding may result in bias in continuing education, such should be
addressed by the profession rather than by the agency. Although
enlisting multiple sponsors would likely reduce the potential for bias
toward any one product, the agency believes that this approach may not
be practical, in all instances, for all FDA-regulated products.
D. Background: Promotion, Education, and Independence
11. Some comments objected to language in the background section of
the draft policy statement indicating that, in assessing whether an
industry-supported activity is independent, the agency will examine
whether and to what extent the company ``is in a position to
influence'' the presentation. They contended that the correct inquiry
is whether a company has actually influenced a presentation, not
whether a company was in a position to influence the presentation.
The agency cannot, in all cases, presume a provider to be
independent merely because there is no documented attempt by the
supporting company to influence the program. Business relationships or
other relationships may influence a provider. A provider whose
continued existence depends on the funding and goodwill of a supporting
company may, for practical purposes, be in the same position as a
company employee, who depends on his or her salary. Whether or not a
company is in a position to influence the presentation is important in
determining whether the activity is independent.
12. One comment objected to the first sentence of the fifth
paragraph to the background section of the draft policy statement; this
sentence indicated that, in assessing whether an activity is
independent, the agency will examine whether and to what extent the
company is in a position to ``otherwise use the presentation as an
advertising vehicle.'' The comment contended that this language is
ambiguous as to what might cause the agency to conclude that a
supporting company has otherwise used a presentation as an advertising
vehicle.
The agency agrees that clarification may be helpful. Accordingly,
FDA has revised the text to state that the agency will examine whether
and to what extent the company is in a position to ``otherwise
transform an ostensibly independent program into a promotional
vehicle.''
13. One comment suggested that the example provided in the
parenthetical statement in the fifth paragraph to the background
section of the draft policy statement (57 FR 56412 at 56413) be changed
from ``if the provider believes that future financial support from the
company depends upon producing programs that promote the company's
product'' to ``if the provider has reason to believe * * *.''
The agency agrees with the suggested change and has revised that
section of the final guidance accordingly.
E. Policy: Scientific and Educational Activities Supported by Industry
The draft policy statement, in discussing FDA policy generally,
stated that the agency ``has not regulated and does not intend to
regulate under the labeling and advertising provisions of the act
industry-supported scientific and educational activities that are
independent of the influence of the supporting company'' (57 FR 56412
at 56413). The agency further stated that
[[Page 64084]]
``companies and providers who wish to ensure that their activities will
not be subject to regulation should design and carry out their
activities based on a written agreement * * * that the provider will be
solely responsible for designing and conducting the activity * * *.''
14. Some comments contended that to make the provider solely
responsible for design and conduct of an educational activity
excessively restricts supporting company involvement. They suggested
revising the text to make the provider ``ultimately'' responsible for
design and conduct of an educational activity.
In order to maintain the concept of independence described in this
final guidance, it is important to retain the concept of provider
``sole responsibility'' for the design and conduct of the activity.
This guidance is not designed to restrict companies from continuing to
provide programs for health care professionals, but to distinguish
between activities that are otherwise independent from the promotional
influence of the supporting company and those that are not. A provider
who merely adopts a company-designed presentation has not functioned as
a truly independent educational provider.
1. Written Agreement--Generally
Although the draft policy statement did not require a written
agreement, it did state that a written agreement can ``play an
important role in helping to ensure that an industry-sponsored activity
comes within the safe harbor traditionally recognized by the agency for
independent scientific and educational activities'' (57 FR 56412 at
56413). The draft policy statement also described 10 elements the
agency would anticipate in such written agreement.
As discussed in comment 15 of section II.E.1. of this document, the
final guidance was modified to place less emphasis on a written
agreement, but states that a written agreement is one way to document
what measures were taken by the parties to maintain the independence of
an activity.
15. Several comments suggested that a written agreement between the
provider and supporting company was required and overly burdensome,
both substantively and administratively. These comments identified a
number of possible consequences including, foremost, that the written
agreement would function as a disincentive for industry to support
continuing education, resulting in fewer and lower quality educational
activities. Several comments objected to the written agreement in
general as overly restrictive and intrusive, containing too many
elements, unwieldy, and/or impractical. The comments suggested, among
other things, that there should be no requirement at all, that the
agreement should provide only that the provider exercises final control
and that the agreement should provide only that the program be
objective, balanced, and scientifically rigorous, and that there be
disclosure with all other details left to the parties. Other comments
recommended that the agency develop a ``generic'' written agreement, or
alternatively, provide guidance to national accrediting organizations
as to the content of acceptable standardized written agreements. Still
other comments were supportive of the concept of a written agreement,
did not anticipate that written agreements would be unduly burdensome,
and moreover, maintained that the written agreement would improve the
process of developing meaningful educational activities. Some comments
suggested that, for their purposes, the fact that clear guidance, which
distinguishes regulated from nonregulated activities exists, may be
more important than what the guidance actually contains. The comments
complained that the lack of guidance, and resulting uncertainty as to
the regulatory consequences of industry support for scientific and
educational activities, have made industry reluctant to provide support
for these activities.
As noted earlier, the agency has clarified its intention that a
written agreement between the supporting company and the provider is
recommended, and not required. The final guidance recognizes that a
written agreement is one way of documenting the measures taken by the
provider and the supporting company to ensure independence of an
activity. The agency does not anticipate that a written agreement would
be an undue burden for any of the parties involved in continuing
education for health care professionals. Moreover, the agency
anticipates that such agreements will enhance, rather than detract
from, the quality of industry-supported educational activities.
16. One comment contended that failure to abide by the terms of a
written agreement should subject the parties to additional penalties
beyond those currently provided for in the act.
The agency believes that its existing statutory authority is
sufficient to address industry-supported activities that are subject to
regulation and may be violative.
2. Statement of Purpose
The draft policy statement's ``Statement of Purpose'' section
(section II.A.1.) advised that the company and the provider should
agree that the program ``is for scientific or educational purposes and
not for the purpose of promoting any product and that any discussion of
the company's products will be objective, balanced and scientifically
rigorous'' (57 FR 56412 at 56413).
FDA has deleted the ``Statement of Purpose'' section because the
elements of a written agreement are no longer described in the final
guidance.
3. Control of Content/Selection of Presenters
The draft policy statement stated that the provider would be
responsible for exercising full control over the planning of the
program's content, including the selection of presenters and
moderators. The draft policy statement indicated that companies should
``play no role in the selection of presenters or moderators other than
responding to provider requests'' for such persons, but that companies
could make unsolicited suggestions of speakers to ``nationally
recognized accrediting organizations that compile lists of speakers * *
*'' (57 FR 56412 at 56413). The draft policy statement specified
further details regarding requests for speakers, such as having
companies agree to provide, where reasonably possible, the names of
more than one suggested presenter and to ``disclose all known
significant financial and other relationships between the company and
suggested presenter.'' The draft policy statement stated that providers
should agree to seek suggestions for presenters from sources other than
the company, to make independent judgments on appropriate presenters,
and to select presenters ``representing an appropriate diversity of
legitimate medical opinion on the topic under discussion when the
format permits * * *'' (57 FR 56412 at 56413). Additionally, the draft
policy statement stated that providers should agree to disclose whether
a presenter was suggested by the company. The final guidance includes a
factor concerning ``Control of Content and Selection of Presenters and
Moderators'' (section II.A.), which contains most of the concepts
described in the draft policy statement.
17. Several comments objected to the provision in the draft policy
statement concerning presenters suggested by the supporting company.
The comments objected in particular to the statement that the provider
agrees to disclose
[[Page 64085]]
when it has selected a presenter suggested by the supporting company.
These comments contended that such disclosure is unnecessary because it
unfairly raises the specter of bias as to that presenter and, moreover,
the ``Disclosure of Financial Relationships'' element of the draft
policy statement (section II.A.3.) provides for adequate disclosure of
any significant relationship between the presenter and the supporting
company. Other comments contended that the supporting company should
under no circumstances be permitted to suggest presenters.
As stated in the draft policy statement, there is a perceived need
on the part of some providers for assistance from supporting companies
in identifying appropriate speakers. The agency is unwilling, at this
time, to infer undue influence by the supporting company if it responds
to a request from such a provider. Health care professionals are
entitled to know the nature of any involvement by supporting companies
in educational efforts. However, the agency agrees with the comment
that disclosure of any significant relationship between the provider,
supporting company, and presenters or moderators would be sufficient.
The possibility of unwarranted bias against presenters suggested by
industry should be dealt with in the open environment of scientific
exchange. Accordingly, the final guidance does not address specific
disclosure of the supporting company's suggestions for speakers or
moderators.
18. Some comments objected to the statement that a supporting
company, when responding to a provider request for suggestions of
presenters, agree to disclose all known significant financial and other
relationships between the suggested presenter and the supporting
company. They argued that this provision is burdensome and redundant in
light of the disclosure obligation in the ``Disclosure of Financial
Relationships'' section of the draft policy statement (section
II.A.3.).
The agency believes that a presenter's significant relationships
with a supporting company are, like a presenter's qualifications,
essential to a provider's informed decision as to the appropriateness
of a suggested presenter. Although the final guidance does not
specifically state that the agency will consider whether the supporting
company disclosed such relationships, it is suggested that this type of
disclosure be made.
The agency does not agree that this disclosure is redundant with
the ``Disclosures'' section of the final guidance (section II.A.)
because the two provisions serve different purposes. The disclosure
made by the supporting company when suggesting a speaker is to assist
the provider in evaluating the appropriateness of the suggestion. The
``Disclosures'' section of the final guidance is to inform the
audience, at the time of the program, of the presenter's relationship
with the supporting company in order to provide the audience a
perspective from which to evaluate the information conveyed by the
presenter. The agency does not view the supporting company's disclosure
when suggesting a presenter as more comprehensive than the disclosure
to the audience in the ``Disclosures'' section.
4. Disclosure of Financial Relationships
The draft policy statement suggested that, as part of the written
agreement, the provider agrees to ``ensure meaningful disclosure'' of
the company's funding of the activity and ``any significant
relationship between the provider and the company and between
individual presenters or moderators and the company * * *'' (57 FR
56412 at 56413). In the final guidance, this provision is incorporated
in the general ``Disclosures'' section.
19. Several comments sought clarification as to what is meant by
``meaningful'' disclosure and ``significant'' relationships. Several
comments also contended that this provision is an administrative
burden, and that it places a disproportionate burden on the provider,
as opposed to the supporting company and presenters.
Significant relationships are relationships that may give rise to
actual or perceived conflicts of interest. The concept of disclosure of
relationships that may give rise to conflicts of interest has specific
and well-understood application to medical and scientific discourse
(e.g., in publication and in the peer-review process). The agency
envisions that this provision can be satisfied by disclosing the
existence of and characterizing significant relationships, and need not
include further detail such as the amount of compensation or funding
received. Thus, this disclosure should impose only a minimal burden on
providers, presenters, and supporting companies. Where there is a
question as to whether a relationship is significant, providers,
presenters, and supporting companies should disclose the existence of
the relationship.
Meaningful disclosure is disclosure that is reasonably calculated
to reach the relevant audience in a manner that will alert them to
potential biases. The provider should determine how to ensure that
disclosure is meaningful.
20. One comment contended that significant relationships between
the supporting company and providers and presenters should preclude any
characterization of the activity as an independent educational activity
inasmuch as disclosure is not adequate to cure the taint of influence.
It is neither practical nor justified to make a potential conflict
of interest an absolute bar to participation in an independent
educational activity. Disclosure of such potential conflicts is a
workable means to address the potential for bias in medical and
scientific contexts, and there is no reason to believe that it will be
any less workable in addressing the potential for bias in the context
of industry-supported scientific and educational activities.
21. Another comment argued that disclosure is the only element of
the written agreement that should be retained, that company involvement
should be permitted, and that it should be left to the judgment of the
audience as to how to evaluate the content of the program.
While disclosure may be deemed by some in the health care
profession a proper solution to concerns about bias, the agency's
concerns are not wholly satisfied by disclosure. Under the act, the
regulated industry cannot promote its products for unapproved uses, or
otherwise promote drugs, biologics, or medical devices in ways not
consistent with approved labeling, even in the context of unbiased
presentations in which the company's role is fully disclosed.
Discussions of unapproved uses, or other matters not consistent with
approved labeling, should occur in a context of independent scientific
or educational activity produced by organizations and individuals who
are not involved in marketing the products. Thus, disclosure alone is
not adequate to ensure independence in industry-supported scientific
and educational activities as it does not insulate such activities from
the substantive influence of supporting companies.
5. Supporting Company Involvement in Content
The draft policy statement suggested, as part of the written
agreement, that a company agree not to engage in scripting, targeting
of points for emphasis, or other activities that are designed to
influence a program's content. The draft policy statement indicated,
however, that companies could provide ``limited technical assistance *
* * in preparing slides or
[[Page 64086]]
audiovisual materials * * *'' (57 FR 56412 at 56413). In the final
guidance, this discussion is included in the ``Control of Content and
Selection of Presenters and Moderators'' factor. Although discussion
regarding ``limited technical assistance'' is not included in the final
guidance, as discussed in the response to comment 22 of section II.E.5.
of this document, technical assistance is a concern.
22. Several comments recommended that the agency more clearly
define the limits of permissible technical assistance. Some comments
argued that the policy should preclude all technical assistance, as to
permit such assistance opens the door to influence. Other comments
raised concerns that the policy is overly restrictive as to technical
assistance in which supporting companies may engage. Several comments
argued that supporting companies should be allowed to script, target
points for emphasis, and provide unlimited technical assistance so long
as such influence does not unfairly bias the program.
The agency continues to believe that the supporting company should
not engage in activities that could influence the presentation's
content. Activities such as scripting and targeting points for emphasis
can have a direct effect on the presentation's direction, balance, and
overall message. A company-designed and financed presentation, even if
approved by an independent provider, remains, in the agency's view, an
activity that is not independent.
In addition, because the agency shares the concern that technical
assistance may open the door to influence, the agency suggests that the
supporting company should provide limited technical support only in
response to an unsolicited request for assistance from either the
provider or a presenter.
6. Ancillary Promotional Activities
The draft policy statement indicated that the written agreement
should include an agreement by supporting companies to not have any
promotional activities or promotional exhibits ``in the same room or in
an obligate path to the educational activity, unless the exhibit is
within an area that is designated for general exhibits and includes
exhibits from different companies marketing alternative or competing
therapies.'' Additionally, providers would agree that no advertisements
for the supporting company's products would appear in any materials
disseminated in the program room (57 FR 56412 at 56413). The final
guidance states that one factor the agency will consider is whether
there are promotional activities in the meeting room.
23. Many comments were concerned about the scope of this element on
ancillary promotional activities by supporting companies, specifically
the language on promotional activities occurring in an obligate path to
the educational activity. These comments asserted that this aspect of
the policy was, in general, unduly restrictive; contrary to the normal
practice of placing exhibits in advantageous locations; it would have a
disproportionate effect on smaller, sole-sponsored, local meetings to
the extent that it may make supporting companies reluctant to fund
local continuing education activities; and it placed FDA,
inappropriately, in the position of influencing meeting facility
layout, including routes of ingress and egress into meeting facilities.
As a consequence, the comments argued that certain facilities would
become more or less attractive venues for educational activities on the
basis of physical layout alone. One comment contended that the
discussion regarding ancillary promotional activities is overly
permissive and blurs the distinction between independence and
promotion, which the comment viewed as contrary to the stated purpose
of the policy. Another comment argued that the close juxtaposition of
an independent educational activity and a promotional activity may
sharpen rather than blur the desired distinction.
The agency is persuaded that the language in the draft policy
statement regarding promotional activities in an obligate path to the
educational activity should be deleted from the final guidance. This
provision is problematic in that its application may turn on the
physical layout of a building, and thus may favor certain facilities
and providers. Moreover, the agency is not convinced that this is
necessary to preserve the distinction between an independent
educational activity and a promotional activity. The agency gives some
credence to one comment's observation that the close juxtaposition of
an independent educational activity and a promotional activity may be
as likely to sharpen as to blur the desired distinction between
independent and promotional activities. Because its contribution to
preserving the distinction between an independent activity and a
promotional activity is uncertain, there is not adequate justification
for this provision in light of its differential impact on affected
parties. Consequently, the final guidance has been revised to suggest
that ancillary promotional activities should not take place in the
actual meeting room.
24. Several comments interpreted the draft policy statement as
precluding a sole exhibitor from having a promotional exhibit at either
a sole or multi-sponsored educational activity. The comments objected
that this would cause the issue to turn on whether other exhibitors
chose to exhibit.
These comments misinterpret the draft policy statement. The
provision on ancillary promotion would not preclude sole exhibitors
from exhibiting at either sole-sponsored or multi-sponsored programs.
The final guidance, as revised, merely suggests that promotional
activities (sole exhibitors or otherwise) not take place in the meeting
room. Companies are otherwise free to exhibit at sole or multi-
sponsored programs without threatening the independent status of the
activity.
7. Objectivity and Balance and Limitations on Data
The draft policy statement contained two sections, entitled
``Objectivity and Balance'' and ``Limitations on Data'' as part of the
suggested written agreement. Under ``Objectivity and Balance'' a
provider would agree to take steps to ensure that data are objectively
selected and presented, that both favorable and unfavorable information
about a product are fairly represented, and that there is a ``balanced
discussion of the prevailing body of scientific information'' about a
product and reasonable, alternative treatment options. In ``Limitations
on Data'' the provider would agree to have ``meaningful disclosure'' of
any limitations or uncertainty on data. Neither of these elements are
included as factors in the final guidance.
25. Several comments maintained that these two sections would place
excessive regulatory burdens on providers because providers would be
obliged to screen presentations in advance and would appear to be
responsible for the behavior of presenters who are, to an extent,
beyond the provider's control. Other comments argued that these
sections are inconsistent with the concept of independence because they
effectively regulate content in an ostensibly independent program in a
manner similar to the fair balance requirement in FDA's advertising
regulations. Some comments argued that these elements are necessarily
subjective in practice and that, among other things, time limitations,
venue, and educational objectives may influence the extent to which a
program is considered balanced or discusses data limitations. Other
[[Page 64087]]
comments maintained that these elements state only that which should
reasonably be expected in legitimate, independent scientific discourse
and thus are not appropriately the subject of a regulatory policy. They
maintained that having these elements as part of the written agreement
is paternalistic because it does not credit the audience with the
intelligence and means to require objectivity and balance and to put
presented data in its appropriate context. Still other comments
supported these elements.
The agency is persuaded that these elements are not necessary to
help ensure that sponsored programs are nonpromotional and independent
of the supporting company's influence, and that there is adequate
disclosure of relationships and information that is relevant to the
audience's assessment of information presented. The agency is also
persuaded that objectivity, balance, and disclosure of data limitations
are commonly understood to be elements of typical, independent
scientific discourse. The agency is convinced that these issues should
be left to providers, presenters, and accreditors of educational
activities and, therefore, these elements are not included as factors
the agency will consider in determining independence.
8. Discussion of Unapproved Uses
The draft policy statement suggested that if unapproved uses are
discussed, the written agreement include an agreement by the provider
that presenters disclose that the product is not approved in the United
States for the use under discussion. The final guidance states that the
agency will consider whether there is meaningful disclosure, at the
time of the program, to the audience of whether any unapproved uses of
products will be discussed.
26. Several comments contended that this element is inconsistent
with the concept of an independent program, burdensome, and would limit
scientific exchange. Several comments added that the ultimate content
of presentations is beyond the control of providers and that it would
be cumbersome to flag discussion of unapproved products or uses
throughout a program or presentation. Comments from the oncology
community argued that this aspect of the written agreement would be
especially burdensome for oncology educational programs because it
would likely apply to the bulk of product uses discussed. One comment
suggested using a general disclaimer in the program materials that not
all products or product uses to be discussed are approved uses in the
United States, rather than requiring presenters to specifically
identify those unapproved uses.
The agency is persuaded that this disclosure, as presented in the
draft policy statement, has the potential to be burdensome and unwieldy
in practice, particularly in specialty areas where a high percentage of
product use is for unapproved uses. Therefore, the final guidance does
not include as a separate factor that providers have presenters
disclose that a particular product or use is unapproved.
The agency, however, believes that the fact that a program may
include discussion of products or product uses that are not approved is
a matter that warrants disclosure. This fact, along with acknowledgment
of the supporting company's funding of a program, is important to an
audience's assessment of the information presented. The agency believes
that a less burdensome disclosure than that proposed in the draft
policy statement would suffice. The agency agrees with the comment that
a single, general disclosure as to whether a program, or individual
presentations in a program, will include discussion of products or
product uses that are not approved would be adequate to address the
agency's concern. Therefore, FDA has deleted the ``Discussion of
Unapproved Uses'' element from the final guidance, and the factor
discussing ``Disclosures'' has been revised to suggest that the
provider ensure meaningful disclosure, at the time of the program, to
the audience of whether any unapproved uses of products will be
discussed. Ideally, such disclosure should occur in conjunction with
disclosure of the supporting company's financial support for the
program. This disclosure could take the form of a statement in the
program materials or be delivered verbally at the start of the program.
27. Several comments contended that presenters should be permitted
to report on foreign regulatory status, and pending U.S. applications
and supplements for products discussed.
Nothing in this final guidance should be construed as barring
presenters from discussing the foreign regulatory status of a product,
or indicating that a product being discussed is the subject of a
pending new drug application or supplement in the United States.
9. Opportunities for Debate
The draft policy statement included an element that the provider
agree, in the case of live presentations, to provide ``meaningful
opportunities for scientific debate or questioning'' during the program
(57 FR 56412 at 56414). The final guidance includes a similar factor
entitled ``Opportunities for Discussion.''
28. Several comments contended that it is not always practical to
provide meaningful opportunities for debate because such opportunities
may be contingent on the size of the program, time constraints,
willingness of an audience to participate, and other factors unrelated
to a program's independence. These comments maintained that an
opportunity for debate should be a goal of an independent program, but
not included in all activities. Other comments asked the agency to
clarify what is meant by ``meaningful opportunities'' for debate.
The agency agrees that opportunities for debate should be a goal of
an independent program, but it is not practical or appropriate in all
activities. Factors unrelated to a program's independence could
intercede to preclude an opportunity for meaningful debate. The
agency's inquiry concerning this factor likely would be whether a
program format reasonably afforded an opportunity for discussion, and
such opportunity was nonetheless not provided. This finding may suggest
an intent to insulate from peer scrutiny the data and ideas presented.
As with the other factors in this final guidance, a finding that a
meaningful opportunity for discussion was denied may suggest that a
program was not independent despite representations to the contrary.
Certain comments seeking clarification of what is meant by a
``meaningful opportunity for scientific debate or questioning'' seem to
have inferred a more stringent concept than was intended. The goal
contemplated is no more than a reasonable opportunity for the type of
question and answer session typical of continuing education activities.
The agency has changed the word ``debate'' to ``discussion'' to reflect
this less structured intent.
10. Schedule of Activities
The draft policy statement suggested that the company and provider
agree to, and record in the written agreement, the dates, times, and
locations of all presentations (57 FR 56412 at 56414).
29. Several comments contended that it is overly burdensome to have
a supporting company and provider identify all presentations to be
held. They maintained that this is problematic in that not all future
programs may be anticipated at the time a provider and supporting
company enter into an arrangement. Several comments maintained that the
fact of multiple presentations of the same program should not be viewed
as
[[Page 64088]]
suggesting possible promotional intent so as to warrant higher
scrutiny. Some comments argued that it is desirable to repeat certain
programs for public health reasons, that demand for additional programs
suggests that a program is valuable, and that repeat presentations are
desirable as they are the most efficient way to disseminate valuable
information. Some comments contended that there should be a distinction
between multiple programs that were agreed to in advance of any
presentation and those that were agreed to after the fact, and only the
later should be subject to higher scrutiny.
The agency is convinced that it may be difficult for a supporting
company and provider to document the dates, times, and locations of all
presentations in advance and, therefore, has removed this element from
the final guidance. The agency, however, remains convinced that, in
some circumstances, the fact of multiple presentations may be an
indicator of supporting company influence. The agency agrees that
multiple presentations of the same program are more troublesome when a
supporting company agrees to fund additional programs after having
viewed the initial program. This opportunity to view a program in
advance of a decision to fund additional programs provides an obvious
degree of control over content of multiple presentations. Thus, these
programs would be viewed with greater scrutiny.
F. Other Factors in Determining Independence
The draft policy statement stated that if, notwithstanding the
presence of a written agreement, a question is raised regarding product
promotion, FDA would consider several ``possible indicia of company
influence.'' These factors included, among others, an examination of
the relationship between the provider and supporting company, the
provider's involvement in the company's sales or marketing, logistical
assistance provided by the company, the program's focus (whether the
program concentrated on a single product), and gifts to encourage
attendance (57 FR 56412 at 56414). The draft policy statement also
indicated that ``no individual factor is likely by itself to stimulate
an action based on lack of independence.'' Many of the factors that
were discussed in the ``Other Factors in Determining Independence''
section of the draft policy statement (section II.B.) have been
retained in the final guidance.
30. Several comments advised deleting this entire section from the
policy. Another comment contended that the articulated factors undercut
the protection afforded by the policy by permitting post hoc review of
a provider's decisions for indications of possible influence.
The agency believes that it is important to consider the actual
conduct of the parties in determining whether a supporting company has
acted to transform an educational activity into a promotional
presentation for its products. By including this discussion in the
``Factors Considered in Evaluating Activities and Determining
Independence'' (section A. of the final guidance), the agency believes
that there will be less concern regarding post hoc review.
1. Relationship Between Provider and Supporting Company
The draft policy statement noted that legal, business, or other
relationships between the company and the provider might place the
company in a position whereby it could influence the content of the
activity. This discussion is contained in the final guidance as a
factor the agency will consider.
31. Some comments contended that there should be clarification of
the types of relationships that predispose a supporting company to
influence content. Some comments argued that ``influence'' is too
expansive or vague a term, and that, a more appropriate inquiry would
be supporting company ``control.''
As discussed in response to comment 14 of section II.E. of this
document, a company-designed presentation does not become independent
merely because it is approved by a provider who has final editorial
control. The agency believes that ``influence'' is the most appropriate
term to describe the basic concept of independence. The final guidance
does, however, identify several types of relationships that may
predispose a supporting company to influence content (e.g., legal
relationships, business relationships, a provider that is owned by, or
is not viable without the support of the supporting company).
32. One comment contended that legal, business, or other
relationships should not be at issue where ``a provider has documented
independence through accreditation from a major accrediting
organization.''
There is no basis for assuming that accreditation of the provider
by a major accrediting organization will, in and of itself, ensure that
the provider will not be subject to influence as a result of a
relationship with the supporting company.
2. Provider Involvement in Sales or Marketing
The draft policy statement listed, as another factor in determining
independence, the provider's involvement in advising or assisting in
the sales or marketing of a company's product. The discussion in the
draft policy statement stating that ``individuals who are involved in
promotion of a company's products may not function in the role of
independent provider, but could be selected by an independent provider
to function as a speaker or moderator'' (57 FR 56412 at 56414) has been
deleted. The remaining discussion is listed in the final guidance as a
factor the agency will consider.
33. Some comments identified situations where this provision may be
interpreted so as to preclude institutional providers and/or companies
from interacting due to minor or unrelated involvement with the
supporting company.
The primary concern of the agency, as reflected in the draft policy
statement, is with relationships that may affect the provider's
independence. A relationship between a provider member or employee and
a supporting company will not, in and of itself, imply influence by the
company. If, however, company employees or individuals acting on behalf
of the company are actively involved in provider decisions on the
content of provider activities sponsored by the company, there may be a
reason to question the provider's independence.
34. Some comments contended that this provision does not adequately
distinguish between advertising agencies involved in sales and
advertising, and communications companies involved in education, which
also may be viewed as a marketing function, nor does it allow for the
existence of advertising and communications (or education) divisions
within the same company.
FDA acknowledges that certain providers are often involved in both
promotional activities and independent educational activities. The
involvement of a provider in both types of activities does, however,
raise questions about whether an educational activity is, in fact,
being utilized as part of a promotional campaign.
While the final guidance does not preclude the use of the same
provider in a promotional effort and an independent educational
activity, such an arrangement poses obvious difficulties. Companies
choosing to engage a provider in both activities should be especially
concerned about the
[[Page 64089]]
assignment of provider personnel to the different activities. The
agency will not ordinarily regard provider personnel who serve as
company agents for company promotional activities to be independent for
other company-sponsored scientific or educational activities.
3. Provider's Demonstrated Failure to Meet Standards
The draft policy statement identified, as a factor in determining
independence, the provider's record of failure to meet standards of
independence, balance, objectivity, or scientific rigor when putting on
ostensibly independent educational programs (57 FR 56412 at 56414).
This discussion is listed in the final guidance as a factor the agency
will consider.
35. Some comments sought clarification as to what is meant by, or
what criteria support a conclusion of, ``demonstrated failure to meet
standards'' on the part of a provider. Some comments contended that
this is an unworkable requirement as supporting companies are not in a
position to know of a provider's past failures to meet standards in its
educational programs.
It is not unreasonable to expect due diligence on the part of
companies when contracting with providers. In exercising due diligence,
supporting companies should conduct a reasonable evaluation of all
information readily available about a provider.
4. Logistical Assistance
Another factor in determining independence contained in the draft
policy statement was the extent of logistical assistance provided by
the supporting company. The draft policy statement specifically
mentioned that ``significant contact'' between industry representatives
and presenters might indicate an attempt to influence a presentation
(57 FR 56412 at 56414). As discussed in comment 36 of section II.F.4.
of this document, this discussion has been deleted from the final
guidance.
36. Several comments argued that the logistical assistance element
was too ambiguous a standard as it is not clear what is meant by
``significant contact.'' Some comments argued that, notwithstanding any
ambiguity, significant contact between a presenter and a supporting
company representative should not be an indicator of influence as the
agency's inquiry should focus on actual attempts to influence or
control the content of a presentation. They maintained that supporting
company representatives have ongoing relationships with presenters that
would make compliance with a generalized ``significant contact''
standard problematic.
While the agency believes that the ``significant contact'' standard
is amenable to clarification, it need not be, as the agency is
persuaded that its inquiry concerning contacts between a presenter and
a supporting company in conjunction with a sponsored program should
focus on attempts to influence, rather than on volume or nature of
contacts. A supporting company, among other factors for determining
independence, should not script, target points for emphasis, or engage
in other activities that are designed to influence the content of a
program. The agency believes that factor alone is adequate to address
the agency's concern as to contact between a supporting company
representative and a presenter in conjunction with a sponsored program.
Therefore, discussion of the logistical assistance provision has been
deleted from the final guidance.
5. Suggestion of Presenters
The draft policy statement acknowledged that some providers
perceive a need to ask the supporting company to suggest presenters.
The draft policy statement stated that if a company suggests presenters
who ``are or were actively involved in promoting the company's products
or who have been the subject of complaints or objections with regard to
presentations that were viewed as misleading or biased in favor of the
company's products,'' FDA might infer promotional intent on the
company's part (57 FR 56412 at 56414). This discussion has been
incorporated, in part, into the factor concerning ``Control of Content
and Selection of Presenters and Moderators'' in the final guidance.
37. Some comments contended that a supporting company may not be in
a position to know if a presenter it suggests has been the subject of
complaints with regard to presentations viewed as biased in favor of
the company's products. They maintained that this provision should
expressly indicate that supporting companies are only accountable for
knowingly suggesting presenters that have been the subject of such
complaints.
The agency believes that the company should be familiar with the
presenter's background and should be willing to make a reasonable
inquiry before recommending the name of a presenter to the provider. In
the final guidance, this discussion has been incorporated in the factor
concerning ``Control of Content and Selection of Presenters and
Moderators.''
38. Some comments contended that there should be no inference of
promotional intent arising from a supporting company's suggestion of a
presenter who has been involved in promoting a company's products. They
argued that actual influence of, rather than intent to influence, an
activity is the relevant inquiry, that the scope of activities that may
be viewed as involvement in product promotion is unclear, and that any
relationship between the presenter and the supporting company can be
adequately addressed through disclosure.
The agency is concerned about the ability of a supporting company
to hire an individual to engage in promotional activities for the
company and to actively support the appearance of the same individual
as a presenter in an independent educational activity sponsored by the
company. The agency does not agree that a retrospective finding of
actual influence, which may be extremely difficult to document, is the
relevant inquiry. The issue is whether the company is in a position to
influence program content by suggesting a presenter who is a paid
product promoter. The suggestion by supporting companies of presenters
selected from their company maintained list and/or their marketing
consultants may be viewed as an attempt to influence the content of the
program. The agency will not ordinarily infer such intent when a
provider independently selects a presenter who has been involved in
product promotion for a supporting company. Disclosure cannot overcome
the lack of independence that will ordinarily result from companies
suggesting promoters as presenters in such programs.
6. Focus on a Single Product
The draft policy statement indicated that one factor in determining
independence might be whether the program content was focused on a
single product marketed by the supporting company or a competing
product except when existing treatment options were so limited as to
preclude any meaningful discussion of alternative therapies. The draft
policy statement noted that each treatment option did not have to be
discussed with equal emphasis, but that emphasis on newer or more
beneficial treatments should be provided ``in the context of a
discussion of all reasonable and relevant options'' (57 FR 56412 at
56414). This discussion has been incorporated in the factor concerning
the ``Focus of the Program'' in the final guidance.
[[Page 64090]]
39. Some comments contended that focus on a single product should
not be regarded as a factor that may suggest lack of independence, as
single product programs are useful, especially during a product's
launch phase, and choice of topic should be at the provider's
discretion and should confer no negative inference.
FDA agrees that single product programs may be useful, especially
during a product's launch phase. However, the agency also recognizes
that single-product programs raise unique concerns about the
independence of a program, because such programs inherently lack the
presentation of competing therapeutic modalities.
40. Several comments contended that to suggest that a program
emphasizing a single product do so in the context of a discussion of
all reasonable and relevant options is unreasonable or impossible given
the time constraints of a typical educational activity.
The final guidance does not suggest that a program emphasizing a
single product do so in the context of a discussion of all reasonable
and relevant options. However, the agency will consider, as one of
several factors, a program's focus on a particular therapy when other
reasonable and relevant options are either not discussed or are de-
emphasized.
7. Multiple Presentations
The draft policy statement indicated that multiple performances of
the same program might result in a higher level of agency scrutiny than
single-performance programs (57 FR 56412 at 56414). The final guidance
states that the agency will consider whether multiple presentations of
the same program are held.
41. Several comments contended that multiple presentations should
not be viewed as suggesting promotional intent so as to warrant higher
scrutiny. They argued that it is desirable to repeat certain programs
for public health reasons, that the demand for multiple programs
suggests that a program is a valuable one, and that repeat
presentations are desirable as they are the most efficient way to
disseminate valuable information. Some comments contended that there
should be a distinction between multiple programs that were agreed to
before the fact and those that were scheduled after the fact. They
contended that only the latter should be subject to a higher level of
scrutiny.
Multiple presentations are just one of a number of factors the
agency considers in determining the level of scrutiny to be applied.
Footnote 4 of the draft policy statement explicitly recognized that
repeat presentations can serve public health interests and that Public
Health Service components sometimes actively encourage multiple
presentations on selected urgent topics. FDA agrees that an agreement
to conduct multiple presentations arrived at prior to commencement of
the initial presentation raises fewer questions than an agreement
arrived at after commencement. The opportunity of a sponsor to view the
initial presentation before agreeing to fund additional presentations
provides an obvious degree of control over content of multiple
presentations.
42. Some comments sought clarification of the scope of activities
that may be deemed multiple presentations. The comments described
examples such as a single broadcast to multiple sites via electronic
media, and a multiple presentation at a single location for the purpose
of accommodating several nursing shifts.
A single broadcast to multiple sites would be regarded as a single
presentation because the sponsoring company could not apply added
control to the additional sites. Thus, the presentation at each site
enjoys an equal degree of independence. This is only slightly less true
for multiple presentations to accommodate several shifts on the same
day, especially when the multiple presentations have been contracted
for in advance. Of course, the delay might be 1 or 2 weeks to
accommodate those who might have been on a different rotation or 1 or 2
months to accommodate newly hired employees. FDA believes that any
increased opportunity for a sponsoring company to deny funding for
subsequent presentations or to edit them will raise a question with
regard to independence.
8. Gifts
The draft policy statement indicated that one factor in determining
independence might be gifts or inducements (other than token gifts)
provided to encourage attendance (57 FR 56412 at 56414). The final
guidance does not contain this factor.
43. One comment argued that this provision should be deleted
because it merely duplicates the Accreditation Council for Continuing
Medical Education (ACCME) guidelines.
ACCME-accredited programs do not represent the full range of
activities to which this final guidance applies, and moreover,
providers of ACCME-accredited programs may not, in all instances,
comply with ACCME-guidelines. Nonetheless, this factor has been deleted
from the final guidance because, upon reconsideration, the agency is
not convinced that the use of gifts or inducements to encourage
attendance is a reliable factor in determining independence.
9. Emphasis on Noneducational Activities
The draft policy statement indicated that an emphasis on
noneducational activities (such as leisure or recreational activities)
would be another factor in determining independence (57 FR 56412 at
56414). The final guidance does not contain this factor.
44. Some comments contended that the agency's concern over whether
the announcement and promotion of an educational activity focuses more
on the educational content than on leisure or recreational activities
ancillary to the activity is vague and that the agency should provide
objective criteria for assessing this issue. One comment contended that
this provision appears to create a weaker standard than that of the AMA
guidelines on gifts to physicians as it seems to indicate that a
program announcement or promotion that focuses equally on education and
leisure would be appropriate. They urged that the language be changed
to require that the program announcement and promotion focus
``predominantly'' or ``almost exclusively'' on the educational aspects
of the program.
The agency continues to view the AMA guidelines as an appropriate
standard for health care professionals. Although the agency agrees that
program promotion, including program announcements, should focus
predominantly on the educational content of the program, it does not
consider greater focus on leisure or recreational activities as reason
to believe that the program may be lacking independence.
10. Audience Selection
Under the draft policy statement, another factor in determining
independence was whether the supporting company's sales or marketing
departments generated the invitation or mailing lists for supported
activities, or whether such lists were intended to reflect sales or
marketing goals (such as rewards for high prescribers of the company's
products or to influence ``opinion leaders'') (57 FR 56412 at 56414).
This discussion is listed in the final guidance as a factor the agency
will consider.
45. Several comments objected to limitations on supporting company
involvement in selecting or otherwise
[[Page 64091]]
generating audiences for educational activities. Some maintained that
supporting company-generated mailing lists should be permitted. Some
maintained that providers should be permitted to enlist the aid of the
supporting company's sales representatives to generate audiences by
distributing program invitations, or by other means, and that this
involvement should not suggest a lack of independence unless a
supporting company is solely responsible for generating an audience.
The agency continues to view company involvement in audience
selection and/or solicitation for attendance as undermining program
independence. The involvement of company sales representatives in the
invitation process creates an opportunity for a sales presentation on
the product that is likely to be discussed at the program. This may
invite a discussion of unapproved uses in a promotional context, thus
making the educational program a part of the company's promotional
campaign. In addition, supporting company involvement in the audience
selection process invites the development of lists that target health
care professionals who are deemed important to attend by the supporting
company. It also invites the selection of a large number of ``peer
influence'' professionals who are likely to be strong supporters of the
company's products. This provides an opportunity for bias and indirect
influence on the content of the program, and it allows the program to
be used as a promotional vehicle for targeted health care
professionals.
46. Some comments contended that the selection of ``opinion
leaders'' as a target audience should not raise an issue inasmuch as
such physicians are deemed important by genuinely independent providers
as well as companies. They argued that opinion leaders are likely the
most efficient purveyors of information derived from educational
activities that, by their very nature, are accessible to only a limited
number of physicians.
The focus on opinion leaders is a standard promotional tactic to
speed acceptance of a new product so as to more rapidly increase market
share. The agency's understanding of educational needs assessments by
providers is that educational programs generally are not directed to
specific opinion leaders. It is the agency's understanding that there
is no such policy on the part of major accrediting organizations such
as ACCME. It is reasonable to question whether a program that targets
``opinion leaders'' may do so for promotional purposes. This inference
of possible promotion, however, is only one of many factors to be
considered should a question be raised concerning an educational
activity purported to be independent.
47. One comment contended that supporting companies should be
permitted to furnish providers with complete specialty and subspecialty
mailing lists.
The agency would not object to a supporting company furnishing a
provider with complete specialty or subspecialty mailing lists.
11. Misleading Title
The draft policy statement indicated that a program's title might
demonstrate a lack of independence if the title failed to fairly
represent the scope of the presentation (57 FR 56412 at 56414). This
discussion has been incorporated in the factor concerning the ``Focus
of the Program'' in the final guidance.
48. One comment argued that, where the title is under the direction
and control of the provider, it is not the proper subject of a
promotional inference as to the supporting company.
Although the title of a program may ostensibly be under the
direction and control of the provider, the agency has observed that a
misleading title may reflect a lack of independence and a desire on the
part of the provider to promote the supporting company's products under
the guise of education. For example, a program entitled ``New
Approaches to Hypertension'' that focuses on a single product
manufactured by the sponsoring company may suggest to the agency that
the program is designed to promote the company's product. A misleading
title is not, in and of itself, dispositive with regard to the issue of
promotional intent. It is only one of a number of factors to be
considered by the agency.
12. Dissemination
Under the draft policy statement, if information about the
supporting company's product presented in the scientific or educational
activity is further disseminated after the initial program or
publication, by or at the company's behest, other than in response to
an unsolicited request or through an independent provider, this would
be another indication of possible company influence (57 FR 56412 at
56414). This discussion has been incorporated into the final guidance
as a factor the agency will consider.
49. Some comments maintained that the independence of an
educational activity is enduring and that the public health is better
served by making written, printed, or graphic program materials readily
available to health care professionals.
Written, printed, or graphic materials containing product
information and disseminated by, or on behalf of, a product
manufacturer are generally viewed as promotional labeling. If, on the
other hand, the materials are prepared and disseminated by the provider
for educational purposes, or the materials are disseminated by the
company in response to an unsolicited request, this would not generally
be considered as a possible indication of company influence.
50. One comment contended that footnote 6 of the draft policy
statement (which noted that repeat performances are permitted when the
decision is made by the provider, possibly with review by a nationally
recognized professional organization) should be deleted, as it appears
to be more restrictive for repeat presentations than other provisions
in the draft policy statement.
The agency believes that footnote 6 of the draft policy statement
is consistent with other provisions of the draft policy statement. As
suggested in the text of the draft policy statement, multiple
performances may cause the agency to exercise greater scrutiny.
However, a decision made by the provider that multiple presentations
are warranted provides some assurance that there is a genuine
professional need for repetition of the program. Nevertheless, FDA no
longer believes that this footnote is necessary and has deleted it from
the final guidance.
51. One comment suggested that the reference to ``publication'' in
section II.B.5 of the draft policy statement be struck as this appears
not relevant to the range of activities contemplated by the policy.
FDA agrees with the comment and has removed the reference to
``publication'' from the final guidance.
13. Complaints
Another factor for determining independence under the draft policy
statement concerned complaints from the provider, presenters, or
attendees regarding attempts by the company to influence content (57 FR
56412 at 56414). This discussion has been incorporated into the final
guidance as a factor the agency will consider.
52. Some comments contended that complaints should be independently
substantiated before becoming a basis for the agency inferring
promotional intent and that the agency should clarify the mechanism for
reporting complaints.
[[Page 64092]]
In general, the agency will not infer promotional intent by a
supporting company without an investigation that substantiates, to the
agency's satisfaction, a complaint or allegation.
The agency declines to establish a formal mechanism for reporting
complaints. FDA receives information through various means, both formal
(as in requests for meetings) and informal (such as letters and
telephone calls). The agency will exercise its judgment and discretion
in deciding whether to take action on a complaint.
G. FDA Reliance on Major Accrediting Organizations
The draft policy statement acknowledged that accrediting
organizations can play an important role in ensuring that industry-
sponsored activities are independent and nonpromotional. The draft
policy statement indicated that FDA would seek to rely to the extent
possible on major accrediting organizations to monitor company-
supported educational activities conducted by their accredited
providers (57 FR 56412 at 56414). In the final guidance, this section
has been renamed ``FDA's Cooperation With Major Accrediting
Organizations'' and it states that the agency will continue to work
with major accrediting organizations to monitor company-supported
educational activities conducted by their accredited providers.
53. Some comments questioned the extent of FDA's intent to rely on,
and to defer to, major accrediting organizations.
Although FDA recognizes the valuable role that accrediting
organizations can play in ensuring that industry-supported educational
activities are independent and nonpromotional, FDA cannot rely
exclusively on such organizations. The ultimate responsibility for
monitoring inappropriate promotion in these programs lies with FDA.
Accordingly, the final guidance has been revised to clarify that FDA
intends to work with major accrediting organizations to monitor
company-supported educational activities conducted by their accredited
providers.
III. Comments
Interested persons may, at any time, submit written comments to the
Dockets Management Branch (address above). Requests and comments are to
be identified with the docket number found in brackets in the heading
of this document. Comments may be submitted at any time and will be
used to determine whether to revise the guidance further.
Dated: November 24, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
The text of the final guidance follows:
BILLING CODE 4160-01-F
[[Page 64093]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.005
[[Page 64094]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.006
[[Page 64095]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.007
[[Page 64096]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.008
[[Page 64097]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.009
[[Page 64098]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.010
[[Page 64099]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.011
[[Page 64100]]
[GRAPHIC] [TIFF OMITTED] TN03DE97.012
[FR Doc. 97-31741 Filed 12-2-97; 8:45 am]
BILLING CODE 4160-01-C
