FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

NOTE TO CORRESPONDENTS                            Print Media: 301-827-6250	
April 27, 2000                                    
                                                  Consumer Inquiries:888-INFO-FDA

FDA TO HOLD PUBLIC MEETING ON
REGULATION OF OTC PRODUCTS

The Food and Drug Administration will convene a public meeting on June 28 and 29, 2000 to discuss the agency's approach to regulating over-the-counter drug products. The purpose of the hearing is to solicit information from, and the views of, interested persons -- including scientists, professional groups, and consumers.

The meeting will be held at the Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD on Wednesday, June 28 and Thursday, June 29, from 8:30 a.m. to 4:30 p.m.

The hearing will focus on the regulation of OTC drug-products, which raises many complex public health issues. Drugs found appropriate for OTC sale have an increasingly vital role in the U.S. health care system.

They can provide consumers easy access to certain drugs that consumers can use safely for certain conditions without the help of a health care practitioner.

To facilitate the discussion, the agency has developed a list of questions and issues related to the development and regulation of OTC drugs. Issues that are of interest to the agency include: criteria to be considered for decisions on OTC availability, classes of drug products that should or should not be made available OTC, consumer understanding of benefits and risks, and FDA's role in switching drugs to over-the-counter status.

Persons who wish to participate in the hearing must file a written notice of participation with the Dockets Management Branch by June 2, 2000. The public should submit comments by August 25, 2000:

The Notice of Public Meeting was published in the Federal Register of April 27, 2000.

For more information, see Questions and Answers: Over-the-Counter Drug Products Public Hearing

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