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Insider: Drug Safety Not FDA Priority

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


Not everyone agrees that this process works as it should. Karen E. Lasser, MD, MPH, is instructor of medicine at Harvard medical school. She's the lead researcher of a recent study of adverse drug reactions to FDA-approved drugs.

"I believe the pharmaceutical industry has more influence than it ought to in getting drugs approved and keeping them on the market," Lasser tells WebMD. "It is not always in the patients' best interest what gets approved. Our study found examples of drugs getting approved despite being known to cause adverse events."

A major issue is a 1993 law -- the Prescription Drug User Fee Act (PDUFA). Recently renewed by Congress, PDUFA lets the FDA charge drug companies for reviewing their products. These fees pay about half the cost of product review. In exchange, the FDA promises to promptly process new drug applications. Critics charge that this pressure to complete the approval process sacrifices patient safety.

"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 They point to several FDA-approved drugs that had to be withdrawn from the market.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.

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