FDA poised for broader powers over drugs on sale

The US Congress last week passed a bill significantly increasing the powers of the Food and Drug Administration (FDA) to police the safety of marketed drugs (see Nature 446, 844–845; 2007). President George W. Bush is expected to sign the bill by 30 September, when a current law expires.

Under the new law, the FDA will for the first time be able to order companies to make label changes on marketed drugs; to run new clinical trials when safety issues emerge; and to fine non-compliant companies up to $10 million. It also includes $225 million in new drug-company-paid user fees that the agency will spend on post-market drug safety.

The bill requires the FDA to cut by 25% the number of waivers it grants to external experts with financial interests in matters on which they are advising the agency. Such waivers allow them to serve on committees that advise the agency on drug approvals, withdrawals and label changes — advice it almost always follows.