FDA/Hill meeting on epileptic drugs

Executive Summary

Rep. Henry Waxman (D-Calif.) and Rep. Tony Coelho (D-Calif.) met with FDA Commissioner Young and Office of Drug Standards Director Peter Rheinstein, MD, on Sept. 30 to discuss concerns over the safety of epileptic drugs. Reportedly, the congressmen emphasized the need for agency caution in regulating epilepsy products. The meeting follows closely on the heels of recent anti-epilepsy drug recalls, including a Class II recall of 50 mil. carbamazepine tablets manufactured by Pharmaceutical Basics Inc.