Report: FDA may consider strengthening generic drug regulations

BETHESDA, Md. The Food and Drug Administration could decide that some generic drugs are not equivalent to their branded counterparts, according to published reports.

Bloomberg reported FDA Center for Drug Evaluation and Research director Janet Woodcock as saying in an interview that the agency was considering strengthening regulations on some generic drugs because some did not appear to work as well as the branded versions, based on statements from some patients and generic drug company employees. Woodcock had just given a speech at a technical conference organized by the FDA and the Generic Pharmaceutical Association.

In 2008, controversy arose amid anecdotal reports that patients taking generic drugs for epilepsy had experienced breakthrough seizures that they had not experienced while taking the branded versions of the drugs. That gave rise to the introduction of generic “carve-out” legislation in 35 states that would have placed restrictions on when a generic drug can be used, though only three of them passed.