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An Infusion Proposed for FDA

7 May 2009 5:33 pm
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Reflecting broad concerns about tainted peanuts, adulterated drugs, and the need for stronger enforcement of standards, the Obama Administration has requested a 19% budget boost for the U.S. Food and Drug Administration, to $3.2 billion. Of that amount, $2.35 billion would come from the government—a $295 million increase—and the rest from user fees paid by pharmaceutical and other companies that FDA regulates. The new FDA budget pays the most heed to food safety; this area would receive a boost of $134 million, to $783 million, an increase of 21%.

Efforts to ensure the safety of drugs and medical devices also got an increase, of 12%.

Finally, the White House wants to give FDA new powers to approve generic biologics, a controversial area where patents on biologics will soon expire, but the companies that now make these products charge that the therapies are too difficult to reliably make generically. Coincidentally, the release of FDA’s budget coincided with the Senate confirmation hearing for Margaret Hamburg, nominated to be FDA’s next leader. Although Senator Orrin Hatch (R–UT) described being FDA commissioner as “a thankless job,” Hamburg seemed enthusiastic and pledged to restore scientific integrity to the agency, modernize antiquated food-safety systems, and, if confirmed, lead in a way “that appropriately balances innovation and regulation.”

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