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Rezulin Recall: Fast-Moving FDA Hits a New Speed Bump


"I think many people are now confused by the way the FDA makes decisions," he tells WebMD.

In an earlier interview with WebMD, the FDA's chief reviewer for this class of drugs, David Orloff, MD, said the agency's preference is to change a drug's label rather than withdraw it. Side effects can be limited if the doctor knows what to expect, he told WebMD.

John Jenkins, MD, a deputy director at the FDA's Center for Drug Evaluation, tells WebMD, "We don't know everything about a drug when it is approved. These rare Rezulin-related liver failures are a demonstration that no drug is without risk, and that those risks constantly must be re-evaluated."

Jenkins also argues that Rezulin was not approved under the "fast track" process. That process, he tells WebMD, did not even exist when the agency received the approval application for Rezulin. However, he says, the agency did give the drug a priority review because it believed at that time that this drug represented an important advance.

The agency has made significant strides in cutting down its overall approval times for all drugs. The average approval time in 1988 was almost 30 months for the approval of 68 new products. In 1999, the agency approved 77 products in an average of about 13 months.

That acceleration has a number of people worried. There are other questionable drugs besides Rezulin that also benefited from this rapid approval process, Wolfe tells WebMD. He would not elaborate because Public Citizen is still "looking into these issues." But future petitions could be filed, he says.

So, the question remains, do these faster approval times represent a lowering of the agency's safety standards? No, says Jenkins. A review of the FDA's overall performance would show that there actually are fewer product withdrawals today than in the past, when the agency was taking a longer time to review drug applications, he tells WebMD.

But the agency might still have a hard time convincing people that it does have their best interests in mind. On one hand, supporters of Rezulin say the withdrawal clearly reflects that the agency is open to outside pressures, meaning that any drug could become a target. And on the other hand, critics of Rezulin say that the agency's approval of that drug and its subsequent withdrawal proves that the FDA failed to do its job because signals for liver damage existed in the early human studies.

Ironically, they both have something in common. They are latest generation of the FDA's critics, a group that at one time simply wanted the FDA to speed things along.



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