Medical Devices and Prescription Drug Policy

Lawmakers: FDA received complaints about firms tied to meningitis outbreak

{mosads}Fifty-three people have died and 700 have fallen ill from the meningitis outbreak, which began last year. The outbreak has been traced to contaminated steroids produced by the New England Compounding Center (NECC).

Energy and Commerce Republicans said the FDA has not been forthcoming with information about the outbreak and the agency’s oversight of NECC and its parent company, Ameridose. FDA officials turned over information about the company only after Republicans threatened to issue subpoenas, the committee said.

“We know the actions of NECC and Ameridose led to 53 tragic and unnecessary deaths, and we know the FDA had ample opportunity to intervene before those tainted vials were ever distributed, but they did not do so,” Reps. Fred Upton (R-Mich.) and Tim Murphy (R-Pa.) said Monday.

They said information the FDA finally provided shows that the agency had received specific complaints about NECC and Ameridose, including complaints about the safety and sterility of their products.