Congress Moves Closer to Drug-Safety Bill

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The bill, passed Wednesday in the House with a 403-16 vote, gives the FDA authority to require post-marketing safety studies, and it requires drug companies to provide timetables for completing these studies. The agency also reserves the right to mandate label changes to a drug or restrict its use or distribution, should problems arise.

But Wolfe noted that a record number of drugs have been approved by the FDA since PDUFA took effect, suggesting the agency has lost power to industry. "There have also been a record number of drugs taken off the market -- many of which should have never been approved in the first place," he said. "At the same time, there has been less congressional oversight," Wolfe added.

In addition, the bill reauthorizes a medical device industry user-fee program. That is expected to add extra cash to FDA coffers.

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Another critic said both the House and the Senate bills are inadequate.

"I signed a letter recommending a repeal of PDUFA," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic and a key player in the Vioxx withdrawal debacle. "PDUFA is part of the problem, not necessarily the solution," he said.

"When you fund a regulatory agency with funds from the industry it's designed to regulate, it creates a dependency that may not be in the best interests of public health," Nissen said.

Still, the new bill is somewhat of an improvement on the status quo, he said.

"I do think this bill is a compromise -- it doesn't have all of the provisions that I would have liked to have seen," Nissen said. "Is it better than nothing? Absolutely. Is it good legislation? I think it is. It offers better protection for drug safety."

He noted that the House bill does boost the fines companies would have to pay if they violated any of the bill's provisions. In addition, the legislation gives the FDA more authority to make drug labeling changes, he said.

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