FDA chief's call for greater oversight of drug compounders triggers Republican skepticism

Nov 16 2012

Members of the House Energy and Commerce Committee Wednesday questioned Food and Drug Administration head Margaret Hamburg and the co-owner of a compounding pharmacy linked with a deadly meningitis outbreak. Hamburg called for Congress to give the FDA greater oversight of compounding pharmacies, which was met with skepticism by Republican lawmakers.

NPR: Lawmakers Clash With FDA Over Meningitis Outbreak
Members of a House subcommittee clashed repeatedly Wednesday with U.S. Food and Drug Commissioner Margaret Hamburg over the outbreak of meningitis caused by contaminated steroid injections (Stein, 11/14).

The New York Times: FDA Chief Seeks Expanded Authority To Improve Safety Of Drug Compounders
The commissioner of the Food and Drug Administration on Wednesday called on Congress to empower the agency to better police compounding pharmacies like the one at the center of a national meningitis outbreak. But Republican lawmakers pushed back, arguing that the agency has enough authority, leaving it unclear whether the House would support efforts to increase oversight (Tavernise, 11/14).

Politico: Lawmakers Lambaste FDA Chief Over Fatal Outbreak
Appearing under subpoena before a House panel, the co-owner of the compounding pharmacy linked to the meningitis outbreak that has killed more than 30 people took the Fifth Amendment and refused to answer questions Wednesday (Norman, 11/15).

Reuters: U.S. Congress Takes Aim At FDA Over Meningitis Outbreak
Members of a congressional committee investigating the deadly U.S. meningitis outbreak accused the Food and Drug Administration on Wednesday of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy. Tainted steroids from the pharmacy, New England Compounding Center (NECC), have so far killed 32 people and sickened 461 in 19 states, according to updated figures from the U.S. Centers for Disease Control and Prevention (Morgan and Berkrot, 11/14).

Medpage Today: Lawmakers Grill FDA Chief Over Compounders
Democratic lawmakers voiced support for giving the FDA greater authority to regulate such pharmacies. But the agency may be slow to gain that power -- if it does at all -- as Republican leaders voiced a more cautious approach, saying the FDA may already have all the authority it needs to have prevented the current outbreak, which has killed 32 people. Hamburg told the House Energy and Commerce Committee that her agency's authority over compounders is unclear (Pittman, 11/14).