[Federal Register Volume 60, Number 193 (Thursday, October 5, 1995)]
[Notices]
[Pages 52196-52197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24815]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0314]
Professional Product Labeling; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an open
public meeting to discuss prescription drug product labeling designed
for health care professionals. The purpose of this meeting is to
present background information and research concerning how approved
prescription drug product labeling (package inserts) may be adapted to
communicate more effectively to professional users, especially health
care practitioners in clinical practice. FDA has developed an initial
prototype of approved product labeling that summarizes the important
information in drug product labeling and reorganizes existing sections.
FDA is seeking comments on the value of these possible revisions to
professional product labeling, and therefore FDA encourages interested
individuals to attend this meeting to obtain relevant information on
which to base their comments.
DATES: The public meeting will be held on Monday, October 30, 1995,
from 9 a.m. to 3:30 p.m. Written comments will be accepted until
January 19, 1996.
ADDRESSES: The public meeting will be held at the Gaithersburg Hilton
Hotel, 620 Perry Pkwy., Gaithersburg, MD 20879. Submit written comments
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. 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. A copy of the
initial prototype can be obtained from the Center for Drug Evaluation
and Research's (CDER's) FAX-on-Demand system, 301-827-0577 or 1-800-
342-2722 (Document No. 0212). A transcript and summary of the meeting
may be seen at the Dockets Management Branch (address above) between 9
a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Kimberly Topper or Angie Whitacre,
Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455.
SUPPLEMENTARY INFORMATION: The major purpose of prescription drug
product labeling is to help ensure that prescribing health care
professionals have the information necessary to prescribe products in a
safe and effective manner. When the agency determines that a sponsor
has provided the requisite scientific data to allow marketing of a
product in the United States, the approved labeling communicates the
conclusions of FDA review of the data in the product's new drug
application (NDA). Because the NDA review process provides access to
the raw data from clinical trials, the product labeling may provide the
only comprehensive, independently reviewed source of medical/scientific
information about newly approved products and new indications for older
products.
The approved labeling also serves as the basis for product
promotion. FDA regulations specify that all advertising claims made
about a product be consistent with its approved labeling (21 CFR
202.1(e)(4)). The approved labeling serves as the basis for fulfilling
the requirement of the Federal Food, Drug, and Cosmetic Act (the act)
that prescription drug advertising include
``* * * information in brief summary relating to side effects,
contraindications, and
effectiveness * * *.'' (section 502(n) of the act (21 U.S.C. 352(n)).
The approved labeling's multiple purposes have contributed to its
evolution. Product labeling has become increasingly detailed and
lengthy over the past several years. FDA is concerned that these
changes not undermine the usefulness of labeling for providing
important information to prescribers. Recent research conducted by the
agency evaluated physicians' perceptions of labeling's usefulness for
their clinical practice. While the data were consistent with previous
studies demonstrating that parts of labeling are extensively used, they
also suggested potential areas where improvements could be made.
FDA has responded to these concerns and data by examining: (1) How
important information in approved labeling could be more effectively
accessed by prescribers, and (2) how a summary of important information
could be designed and added to the approved product labeling. As a
result, FDA has developed a new prototype for approved product
labeling. A copy of this initial prototype can be obtained from CDER's
FAX-on-Demand system (Document No. 0212) or from the information
contact person (address above). This initial prototype represents a
preliminary draft; it is being provided only for the purpose of helping
to facilitate the public's preparation for the meeting. This initial
prototype may change, even prior to the meeting. FDA is interested in
receiving comments on the version of the prototype that will be
presented at the public meeting.
Under 21 CFR 10.65(b), the Commissioner of Food and Drugs has
concluded that it would be in the public interest to hold an open
public meeting to discuss this initial prototype and the value of
possible revisions to professional product labeling. This
[[Page 52197]]
public meeting is designed to give interested parties the necessary
information to understand more fully the background, purpose, and
process of prototype development.
The meeting will be informal, i.e., any interested person may
attend and participate in the discussion without prior notice to the
agency. The meeting will begin with presentations by FDA, followed by a
panel discussion. The panel will be composed of representatives from
industry and from medical and pharmaceutical information professional
groups. The final part of the meeting will be devoted to questions and
comments from meeting attendees.
A transcript and summary of the meeting will be available from the
Dockets Management Branch (address above) approximately 10 business
days after the meeting at a cost of 10 cents per page.
Interested persons may submit to the Dockets Management Branch
(address above) comments on the initial prototype and the meeting. 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. Received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday.
Written comments will be accepted until January 19, 1996, to permit
time for all interested persons to submit data, information, or views
on this subject.
Dated: September 29, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-24815 Filed 10-4-95; 8:45 am]
BILLING CODE 4160-01-F
