Congress acts to improve drug safety

The Baltimore Sun

WASHINGTON // Congress overhauled the government's drug-safety system yesterday, giving the Food and Drug Administration sweeping new powers in a bid to better protect patients from harm caused by drugs such as the painkiller Vioxx.

The legislation, approved by the Senate without debate, is expected to be signed into law by President Bush. It gives the FDA new authority to investigate the performance of drugs after they go on sale and requires companies to post safety data publicly.

"This ought to be reassuring for every family about the safety of their prescription drugs," said Sen. Edward M. Kennedy, the Massachusetts Democrat who chairs the Health, Education, Labor and Pensions Committee.

Under the new law, the FDA can require pharmaceutical companies to closely monitor the use of newly approved medicines for signs of harm, much as they must do while testing the drugs to win approval. The FDA can mine large patient databases kept by Medicare, the Veterans Affairs Department and private health insurers for early warning signs.

In addition, the FDA has the authority to order quick changes to drug labels to warn of safety concerns and to review television ads before airing. Companies will be required to post results from drug trials publicly, whatever the results.

"It means this history of never showing studies that show safety problems will end," said Dr. Steven E. Nissen, a Cleveland Clinic heart specialist whose identification of heart problems caused by the diabetes drug Avandia sparked criticism of the FDA's drug-safety programthis year.

"It's not a perfect bill -- no legislation is -- but in the key areas, the bill moves us forward toward safer and more effective drugs," Nissen said.

The 422-page bill plugs holes in the government's drug-safety system that were exposed when Vioxx was linked to deaths in 2004. Beforehand, most of the FDA's muscle rested in its power to decide whether a drug worked safely enough to go on the market. But the agency had far less power to restrict use ofmedicines later found to be dangerous.

Instead, the FDA was forced to depend on doctors and drug makers to report side effects, a poor approach to quickly detect dangers. The FDA had to ask drug companies to recall medicines that appeared dangerous, and many simply ignored the agency?s orders to study drug performance after receiving approvals.

Patients kept taking drugs such as Vioxx, Avandia and the antidepressant Paxil, critics said, while the FDA took time to confirm serious side effects.

"The biggest problem that the FDA has had in the drug-safety area has been that we haven't had a good system for quickly learning about harmful side effects," said Donald Kennedy, the agency's commissioner from 1977 to 1979. Kennedy praised the new legislation and called on Congress to provide the FDA with the funding needed to carry out its new responsibilities.

Since the federal drug-safety program came under criticism, public confidence in the quality of medicines has plunged, prompting some patients to avoid filling prescriptions. In April, Harris Interactive reported that half of the 1,726 adults surveyed online were not very confident in the safety of prescription drugs and that one-third decided not to take one of the drugs as a result.

The action by Congress tacked the drug-safety provisions to a law, which was up for renewal this year, that allows the FDA to charge pharmaceutical companies for reviews of experimental drugs up for approval. Once the measure is signed into law, the FDA can receive nearly $400 million in fees from drug makers and millions more from manufacturers of medical devices.

"From the standpoint of drug safety, this is the most extensive piece of legislation we've seen in 40 years," Dr. Scott McClellan, the FDA's commissioner from 2002 to 2004, said at a recent symposium on the bill.

The Senate action to approve the measure came one day after the House overwhelmingly endorsed the bill. Sen. Barbara A. Mikulski, a Maryland Democrat who worked on the legislation, called it the "most important drug-safety bill of the decade."

Some of its provisions follow recommendations by an Institute of Medicine panel, which reported last year that the FDA is an agency torn by interoffice disputes and undermined by limited power and resources.

Critics noted that Congress failed to adopt many of the panel's recommendations but said the legislation would increase drug safety.

"It's great that the FDA is getting more tools. They definitely need more tools," said Sheila Weiss Smith, a University of Maryland pharmacy professor who criticized the FDA this month in The New England Journal of Medicine for failing to adopt many of the blue-ribbon panel's recommendations.


Legislation passed yesterday by the Senate gives the Food and Drug Administration new authority to:

Order warnings on drug labels

Review drug ads before they air on television

Make results of drug clinical trials available publicly

Reduce the number of expert advisers with industry ties

Require studies of new drugs' performance

Probe patient databases for early signs of side effects

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