FDA Commissioner: "I Wish We Had Acted Earlier" After 53 Killed, 700+ Sickened By NECC

[hatrack]

EDIT

Drawing on roughly 30,000 pages of documents turned over by the FDA, committee members honed in on the agency's decision, in 2011, to stop initiating inspections of compounding pharmacies until it had finalized new guidance designed to clarify how it would regulate the industry in the face of a complex set of legal decisions dating back years.

The FDA has not made the documents public, saying they are part of the criminal investigation into NECC and Ameridose. But separate reports prepared by Republican and Democratic staff portray an agency that has struggled for nearly a decade to enhance its authority over compounding pharmacies while simultaneously failing to fully exercise the authority it has.

According to the documents and comments from committee members at the hearing, the FDA received a steady series of complaints about NECC even after the agency issued a warning letter to the firm in 2006.

Documents cited by committee members indicate the FDA considered additional inspections and possible enforcement actions but felt it could not take them because it had not responded, two years later, to NECC's reply to the warning letter.

EDIT

http://www.reuters.com/article/2013/04/16/us-usa-health-meningitis-idUSBRE93F1FW20130416

[Lint Head]

1. I thought Romney was an investor in Ameridose.