August 23, 2008

IS THE FDA getting too cautious in drug approvals? If it is, people will die who shouldn’t. But it’s less likely to get blamed.

The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs last year, and is on pace to approve only 18 this year. That’s down from a high of 53 in 1996 and 39 in 1997.

After a few high-profile drug scares, such as the 2004 withdrawal of Vioxx from the market, FDA officials have become gun-shy about approving new products. After all, the agency receives scathing criticism from Congress and the press when an approved drug turns out to be more risky than expected — but rarely for keeping beneficial ones off the market.

Last year alone, the FDA rejected five new cancer drugs, including a breakthrough treatment for prostate cancer called Provenge. A panel of cancer experts that advises the FDA on new drug approvals unanimously agreed that Provenge was safe, and voted 13-4 that it was effective enough. But the FDA demanded still more testing that may delay approval for three years.

In three years, a lot of people will die who might otherwise be saved; quite likely more than would die from even a “dangerous” drug given today’s standards. But the politics are different.

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