WASHINGTON - The Food and Drug Administration yesterday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill signed by President Bush.
At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of the FDA's overall budget, defraying the cost of reviewing products that need agency approval.
Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the bipartisan legislation as a vehicle to reform the FDA's handling of drug safety.
In part, the legislation shifts more of the FDA's attention from experimental drugs pending approval to those already on the market, and gives the agency more power to act when worrisome problems emerge.
"It really represents an important addition to the FDA's authority," said FDA commissioner Dr. Andrew von Eschenbach.
It gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not-yet-approved drugs could be subject to the requirement later.
Still, how the Food and Drug Administration Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees.
The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them. The fine-print list of actions the FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The FDA may have to draft new regulations or guidelines - a process that can take years - to implement some of those provisions, Lutter said.
The legislation does spell out that the FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.
The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year.