Pact would double size of FDA's Office of Drug Safety

06 March 2002 20:50  [Source: ICIS news]

WASHINGTON (CNI)--An agreement between the pharmaceutical industry and the US Food and Drug Administration (FDA) would double the size of the FDA's Office of Drug Safety, sources told CNI Wednesday

The draft proposal - which the Bush administration has yet to approve - would fund an additional 100 or more new staff members over the next five years. It comes as Congress considers reauthorizing the Prescription Drug User Fee Act (PDUFA) which expires in September.

According to sources, the proposed deal would allow fees paid to the agency to speed up the drug approval process to be used to ensure the drugs' safety after they reach the market.

The deal would not require FDA to speed review times at the agency beyond current requirements - 10 months for regular drugs and six months for products put on a fast track.

FDA and PhRMA declined comment on the agreement.

The FDA estimates it will receive approximately $325m (Euro373.6m) for drug reviews in fiscal 2002 with about half coming from industry user fees.

By: Glenn Hess
+1 713 525 2653

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