Woodcock to Congress: Industry Must Be Held Responsible for Drug Quality

-FDA News

04/28/2008 - With the FDA under fire from lawmakers over its apparent inability to regulate the quality of imported products, CDER Director Janet Woodcock told a Senate panel Thursday that companies need to be held accountable for the quality of their drugs and active pharmaceutical ingredients (API).

Recent adverse events and deaths linked to contaminated heparin have brought the drug’s supply chain under tremendous scrutiny as regulators worldwide have instituted testing programs to ensure the supply of the drug is genuine.

The Government Accountability Office (GAO) estimated a significant gap in funding for overseas inspections. The GAO said it would take roughly $70 million annually for the FDA to inspect all overseas facilities every two years, $16 million to $17 million of which would be required for sites based in China. For fiscal 2008, the FDA estimated that it would spend $11 million for all foreign inspections.
 
Woodcock said the FDA’s top priority was to institute an IT system that includes an inventory of every establishment importing products into the U.S., allowing the FDA to verify if the drugs should be allowed entry into the country.

Although the FDA has a business plan to address its IT systems, additional resources are needed for laboratory and inspection operations. Increases in the budget for inspections would need to be substantial. “They are very inadequate right now. We really do not inspect most of the facilities overseas very much at all,” Woodcock said.

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