Drug Approvals Slow

In honor of my favorite head-case Manny Ramirez, here is the FDA just being the FDA:

Stung by a series of drug safety scandals, the Food and Drug Administration has in recent months issued a blizzard of drug-safety warnings and approval times for new drugs are slower.

...drugs approved in the first half of this year took almost twice as long to get that approval as drugs approved in the same period last year.


The agency is also taking more time to review new drug applications. For drugs approved in the first half of 2005, the average time from application to approval was 29 months, compared with an average of 16 months for drugs approved in the first half of 2004. And the F.D.A. is more often asking that drug makers study the safety of their medicines after they are approved.


The agency's growing caution has drawn muted praise and scorn from critics. Dr. Sidney Wolfe of Public Citizen said that the agency still is not cautious enough. Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who for years criticized what he saw as a lack of caution at the F.D.A., said that the agency has overreacted.

"They went from comatose to spastic without any rational period in the middle," Dr. Avorn said.

Jack Calfee, a resident scholar at the American Enterprise Institute who has long criticized the agency for being overly cautious, said that its latest actions are an unfortunate but understandable reaction to fierce public criticism.

"It would be amazing if they did not become more cautious in the wake of the Vioxx episode," Mr. Calfee said.


...F.D.A. observers are predicting that the agency will remain cautious for some time to come.

"The F.D.A. came under a lot of criticism, and it's reacting as regulators do," said Dr. Alastair Wood, an associate dean at Vanderbilt University Medical Center. "Now the pendulum is swinging a bit too far the other way."

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Yet another reason to kill

Yet another reason to kill the FDA now. They cannot even create the pretense of behaving rationally.