FDA To Discuss Regulation of OTC Products

ROCKVILLE, MD- The Food and Drug Administration (FDA) will convene a public meeting on June 28 and 29, 2000 in Gaithersburg, MD, to discuss their approach to regulating over-the-counter (OTC) drug products. Issues of interest include:

1. Criteria to be considered for decisions on OTC availability.

2. Classes of drug products that should or should not be made available OTC.

3. Consumer ability to understand OTC product benefits and risks.

4. Whether the current structure for marketing OTC products is adequate.

5. How rational treatment decisions will be affect by coexisting prescription and OTC therapies.

6. The FDA's role in changing prescription drugs to OTC status.

The FDA is soliciting information and opinions from interested parties. Those who wish to participate in the hearing must file a written notice of participation with the Dockets Management Branch by June 2, 2000. Submissions can be mailed to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; or emailed to FDADockets@oc.fda.gov.