NDMA Meeting Discusses OTC Drug Labeling

The government/industry cooperative process in over-the-countermedicines is moving forward and broadening in scope, Debra Bowen, director of OTC Drug Products at the Center for Drug Evaluation and Research of the US Food and Drug Administration, told a recent Nonprescription Drug Manufacturers Association' conference (Marketletters November 24 and December 1). She cited the large number of prescription-to-OTC switches, OTC approvals and approvable letters issued, labeling reviews and feedback-media meetings held this year.

Dr Bowen told the meeting that her top priority for 1998 is OTC new drug reviews. After that, she said, various rule-making efforts will continue, notably the OTC final labeling rule, completion of the professional aspirin rules, the drug eligibility monograph proposal and looking at the whole area of uniform comparability.

In any cost-benefit analysis of OTCs, the whole labeling issue will become more important, said Bruce Kuhlik, an attorney at Covington & Burling and outside counsel to the NDMA in this area. He urged the FDA to look very carefully at implementation of the label changes, and added that the environmental impact of label changes is another fertile area for study.