[Federal Register Volume 60, Number 236 (Friday, December 8, 1995)]
[Notices]
[Pages 63384-63385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30169]
[[Page 63383]]
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Part V
Department of Health and Human Services
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Food and Drug Administration
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Advertising and Promotion; Draft Guidances; Republication; Notice
Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 /
Notices
[[Page 63384]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95D-0377]
Advertising and Promotion; Draft Guidances; Republication
Note: This document was originally published at 60 FR 62471,
Wednesday, December 6, 1995. Certain text in the guidances were
inadvertently omitted. For the convenience of the reader, the
document is being republished in its entirety.
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing two draft
guidance documents entitled ``Guidance to Industry on Dissemination of
Reprints of Certain Published, Original Data'' and ``Guidance for
Industry Funded Dissemination of Reference Texts.'' These draft
guidances are related to the dissemination, by sponsors of human and
animal drugs, medical devices, and biological products, of certain
reprints of journal articles discussing FDA-approved products, and
reference texts (medical textbooks and compendia). The draft guidances
describe circumstances under which the agency would exercise its
discretion to allow the dissemination of these reprints and reference
texts to health care professionals.
DATES: Written comments by January 5, 1996.
ADDRESSES: Submit written comments on the draft guidance documents to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, or FAX at 301-594-
3215.
FOR FURTHER INFORMATION CONTACT: Ilisa B. G. Bernstein, Office of
Policy (HF-23), Food and Drug Administration, 5600 Fishers Lane, rm.
15-74, Rockville, MD 20857, 301-827-3380, or via internet at
IBernste@bangate.fda.gov.
SUPPLEMENTARY INFORMATION: Health care professionals have always been
able to obtain, from a number of different sources, journal articles
and reference texts (i.e., medical textbooks and compendia), that
discuss human and animal drugs, medical devices, and biological
products. These journal articles and reference texts are commercially
available and may be obtained from publishers, libraries, on-line data
bases, colleagues, bookstores, companies upon request, or other
sources. Sponsors of human and animal drugs, medical devices, and
biological products frequently have expressed a desire to disseminate
reprints of journal articles and reference texts to health care
professionals.
FDA traditionally has taken the position that sponsors who wish to
distribute articles and reference texts containing information that is
inconsistent with the FDA-approved labeling for a product may be in
conflict with the Federal Food, Drug, and Cosmetic Act and implementing
regulations. The agency's position is based on its mission to help
ensure the safety and efficacy of human and animal drugs, medical
devices, and biological products. Sponsors seeking approval or
clearance to market these products must demonstrate to FDA that the
products are safe and effective for their intended use(s). Permitting
sponsors to freely disseminate information that is inconsistent with
the FDA-approved or cleared use(s) would diminish the incentive for
sponsors to perform the clinical studies which are necessary to verify
that the product is safe and effective for the unapproved use.
Furthermore, information disseminated by a biased source may have a
greater potential to mislead the health care professional.
FDA believes that journal articles and reference texts are often
useful to health care professionals. Accordingly, the agency has
reviewed its policies to determine if modifications can be made without
jeopardizing the integrity of the statutorily mandated standard that
marketed drugs be safe and effective and have adequate directions for
their intended use(s). After careful review, the agency is proposing to
modify two of its policies at this time.
First, under one proposed draft guidance, the agency would allow
sponsors to disseminate, under certain circumstances, journal articles
that report the results of well-controlled studies, provided they
represent the peer-reviewed, published version of original efficacy
trials used to support approval, licensure, or clearance. Second, under
the other proposed draft guidance, the agency would allow sponsors to
disseminate, under certain circumstances, reference texts that discuss
human or animal drugs, medical devices, or biological products. FDA has
prepared two draft guidance documents describing the proposed
circumstances under which the agency would exercise its discretion
regarding the dissemination of these materials by sponsors.
FDA is particularly interested in receiving comments on whether the
reprints discussed in the ``Guidance to Industry on Dissemination of
Reprints of Certain Published, Original Data'' should be from ``peer-
reviewed'' journals. If so, please comment on what constitutes a
``peer-reviewed'' journal and what benefits would be afforded if these
reprints are from ``peer-reviewed'' journals.
Interested persons may, on or before January 5, 1996, submit to the
Dockets Management Branch (address and FAX number above) written
comments on the draft guidance documents. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance documents and
received comments are available for public examination in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
The texts of the draft guidance documents follow:
Guidance to Industry on Dissemination of Reprints of Certain Published,
Original Data\1\
I. Purpose of Guidance
Sponsors frequently want to disseminate reprints of articles
reporting the results of the effectiveness trials that have been
relied on by FDA in its approval or clearance of a drug, device, or
biologic product. However, such articles may contain effectiveness
rates, data, analyses, uses, regimens, or other information that is
different from the approved labeling, and might, if disseminated by
the sponsor, be considered violative promotional activities.
\1\This guidance does not apply to reprints of articles that
discuss the specific prohibited uses of animal drugs listed in the
FDA, Center for Veterinary Medicine Compliance Policy Guide 7125.06
or the Animal Medicinal Drug Use Clarification Act implementing
regulations. Although this guidance does not create or confer any
rights on any person and does not operate to bind FDA in any way, it
does represent the agency's current thinking on the dissemination of
reprints of certain published, original data. The agency will
consider individual circumstances on a case-by-case basis.
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Nonetheless, the agency intends to allow the dissemination of
reprints of articles that represent the peer-reviewed, published
version of original efficacy trials, under the circumstances
described in section II. below.
II. Circumstances for Dissemination of Certain Journal Articles
Discussing FDA-Approved Products
1. The principal subject of the article should be the use(s) or
indication(s) that has been approved by FDA. The article should be
published in accordance with the regular peer-review procedure of
the journal in which it is published, and the article reports the
original study that was represented by the sponsor, submitted to
FDA, and accepted by the agency as one of the adequate and well
controlled studies providing evidence of effectiveness. In the case
of a medical device,
[[Page 63385]]
this guidance also applies to studies that were otherwise represented
by the sponsor, submitted to the agency, and accepted by the agency
as valid and material evidence of safety or effectiveness in lieu of
adequate and well controlled studies;
-2. The reprint should be from a bona fide peer-reviewed
journal. A bona fide peer-reviewed journal is a journal that
utilizes experts to review and objectively select, reject, or
provide comments about proposed articles. Such experts should have
demonstrated expertise in the subject of the article under review,
and be independent from the journal;
-3. If the article contains effectiveness rates, data, analyses,
uses, regimens, or other information that is different from approved
labeling, the reprint should prominently state the difference(s),
with specificity, on the face of the reprint. One acceptable means
of achieving the appropriate prominence for this statement is to
permanently affix to the reprint a sticker stating the differences;
and
-4. The reprint should disclose all material facts and should
not be false or misleading.
Guidance for Industry Funded Dissemination of Reference Texts\2\
I. Purpose of Guidance
-Sponsors have also expressed a desire to disseminate reference
texts, i.e., medical textbooks and compendia, to health care
professionals. These texts typically discuss a wide range of medical
diagnoses and treatments, including drug product utilization,
surgical techniques, and other medical topics. FDA recognizes that
such texts are often useful to clinicians in the practice of
medicine.
\2\Although this guidance does not create or confer any rights,
on any person, and does not operate to bind FDA in any way, it does
represent the agency's current thinking on industry funded
dissemination of reference texts. Although FDA believes that this
guidance encompasses the vast majority of reference texts, the
agency will consider, on a case-by-case basis, reference texts that
do not fall within the parameters of this guidance document. This
guidance does not apply to textbooks or compendia that discuss the
specific prohibited uses or animal drugs listed in the Center for
Veterinary Medicine Compliance Policy Guide 7125.06 or the Animal
Medicinal Drug Use Clarification Act implementing regulations.
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-Reference texts often contain information about the use of
drugs, devices, or biologic products in the treatment, diagnosis, or
prevention of disease that may not be consistent with the FDA-
approved labeling for the products (e.g., discussion of unapproved
uses). FDA recognizes, however, that many textbooks do not
necessarily highlight a particular drug or device manufacturers
products. In such instances, industry's desire to disseminate these
reference texts may be in conflict with the Federal Food, Drug, and
Cosmetic Act (the act) and implementing regulations.\3\
\3\Printed materials, such as medical textbooks and compendia,
which supplement, explain, or are textually related to a regulated
product are considered labeling for that product when disseminated
by or on behalf of the manufacturer, packer, or distributor of the
product. See section 201(m) of the act (21 U.S.C. 321(m)) and Kordel
v. United States, 338 U.S. 345, 350 (1948).
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-Nonetheless, FDA intends to permit the distribution of sound,
authoritative materials that are written, published, and
disseminated independent of the commercial interest of a sponsoring
company and are not false nor misleading. FDA, therefore, intends to
allow the dissemination by sponsors of reference texts that discuss
human or animal drug, device, or biologic products, under the
circumstances described in section II. below.
II. Circumstances for Dissemination of Reference Textbooks
-1. The reference text should not have been written, edited,
excerpted, or published specifically for, or at the request of, a
drug, device, or biologic firm (see discussion below);
-2. The content of the reference text should not have been
reviewed, edited, or significantly influenced by a drug, device, or
biologic firm, or agent thereof (see discussion below);
-3. The reference text should not be distributed only or
primarily through drug, device, or biologic firms (e.g., it should
be generally available for sale in bookstores or other distribution
channels where similar books are normally available);
4. The reference text should not focus primarily on any
particular drug(s), device(s), or biologic(s) of the disseminating
company, nor should it have a significant focus on unapproved uses
of the drug(s), device(s), or biologic(s) marketed or under
investigation by the firm supporting the dissemination of the text;
and
-5. Specific product information (other than the approved
package insert) should not be physically appended to the reference
text.
The agency recognizes that there are some useful reference texts
that are written, edited, or published by a sponsor or agent of the
sponsor. In these instances, FDA intends to allow the distribution of a
reference text under the circumstances described in paragraphs 3
through 5 above, when the authorship, editing, and publishing of the
reference text results in the presentation
of a balanced perspective of the subject matter. Typically, this would
be evidenced by an authorship and editorial process that fosters input
from a relatively wide spectrum of sources and that allows for
information from all sources to be considered.
Dated: December 6, 1995.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 95-30169 Filed 12-7-95; 10:42 am]
BILLING CODE 4160-01-F
