[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]



=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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