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Insider: Drug Safety Not FDA Priority

Does Agency Serve the Public -- or the Drug Industry?

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"When you pay a regulatory agency's bills and negotiate with them from year to year, you achieve a little clout and can capture that agency," Stolley says. "The rush to quickly review and approve drugs is probably precipitated by PDUFA act. That was one of main reasons for setting it up. Industry said took too long to get drugs approved."

Woodcock says that PDUFA not only makes drug approval faster, but also improves safety.

"Back in 1993 there were such long drug approval times -- it took over three years to get a drug into the U.S. market," Woodcock says. "Congress and the pharmaceutical industry and the FDA made an agreement to collect fees for services such as reviewing applications. Those fees are connected to timeliness goals for our review process. That program has resulted in doubling the FDA's scientific and medical staff involved in reviewing applications."

FDA critics say the program isn't working. They point to several FDA-approved drugs that had to be withdrawn from the market. Some of these drugs caused fatal reactions -- and in some cases, evidence of the drugs' danger was known before FDA approval. Indeed, Stolley's problems with the FDA arose, he says, when his superiors wouldn't listen to his worries about Lotronex, an irritable bowel syndrome drug approved just before he joined the agency. Patient deaths led to the drug's withdrawal.

The FDA recently made the controversial recommendation to let the drug back on the market under a risk-management program.

"In the last decade we have seen an unusual number of withdrawals soon after approval," Stolley charges. "That is a failure of the FDA's premarketing, clearance, and review processes. It is not a success for postmarketing surveillance."

Lasser also says the FDA approves drugs too soon.

"Drugs aren't adequately studied when they are released onto the market," she says. "So many patients are exposed to them. The problem is in the preapproval stage. Postapproval surveillance isn't going to solve the problem."

But Woodcock notes that there are no more drug withdrawals now than there were in the days before PDUFA. And no matter how much a drug is studied, she says, it's just not possible to foresee all problems.

"The rate of drug withdrawals before PDUFA was 2.7% of all drugs approved -- and the rate right now is exactly the same, 2.7%," she says. "I would agree that this means we haven't gotten better. We would hope to move that rate to zero. We would like to predict the performance of a drug after all those trials, but we aren't that good at it yet. Also, we can't predict how drugs will be used in the market. A number of drugs we have had to take off the market in the last 10 years have been from doctors not using the drug as labeled. But, of course, we would like to do better."

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