Congress Reviews Ranbaxy Approvals

As part of an ongoing investigation into FDA's ability to ensure that food and drugs sold in the U.S. are safe, House Committee on Energy & Commerce Chairman John D. Dingell (D-Mich.) and committee member Rep. Bart Stupak (D-Mich.) sent a letter to FDA Commissioner Andrew C. von Eschenbach on July 22 questioning whether the agency knowingly allowed India's generic drugmaker Ranbaxy to sell substandard drugs in the U.S. (C&EN, July 21, page 10). The letter is in response to a motion, filed by the Department of Justice on July 3 in U.S. District Court for the District of Maryland, that indicates FDA knew about Ranbaxy's alleged "pattern of systemic fraudulent conduct" for at least 18 months. The committee intends to review the premarket approval inspections and "for cause" inspections, which are triggered by suspicious activity, for all Ranbaxy drugs sold in the U.S. to determine whether FDA can justify leaving the products on the market.