Food/Drug Law Institute Education Conference

22 December 1997

Over-the-counter review is becoming a more important and visible part ofthe US Food and Drug Administration's Center for Drug Evaluation and Review operation, CDER director Janet Woodcock told the Food and Drug Law Institute's annual education seminar (Marketletter December 22).

By early December, the CDER had approved 13 OTC New Drug Applications in 1997; some went directly to OTC status and some were switches, she said. Six approvable letters were sent, 17 OTC advisory committee meetings held, 15 Federal Register notices put out for public comment and 48 responses made to Citizen's Petitions, although there is still a backlog in the latter.

There has been a progressive rise in the number of generic submissions; resources have been shrinking in this area but approvals are still rising. One legislative focus has been the timeframe for Abbreviated NDA review, and while the median time to approval has met the 180-day legislative requirement, many are still overdue. The FDA is trying to cut the number of review cycles for generics, she said; it does not want to meet the time deadline by kicking an application into another cycle. The industry also feels total time to approval is more important than meeting the regulatory deadline. Still, the FDA will work hard to meet the new legislation's timeframes, she said. The mean approval time for generics fell from 33.1 months in 1995 to 24.1 months in 1997.

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