FDA in a sorry state Posted by mitcka at 04/06/05 04:15 PM

The Lancet, a major medical journal, has come to the conclusion that “FDA is in a sorry state.” Agreed.

Lester Crawford, Bush’s new FDA commissioner, was the agency’s acting commissioner for almost three years—and during that time he “has shown repeatedly that he lacks the determination to strengthen the weak regulatory culture within the FDA,” according to Lancet’s illustrious editors. I planned to post their February 26 article for everyone to read, but their site is temporarily not allowing new registrations, and you can’t look at the article without registering. So here’s an excerpt:

What is in place or being created so far is, unfortunately for the US public, inadequate to monitor drug safety. What is needed is an FDA chief with the foresight and ability to change a lumbering organization, armed with the legal framework to achieve an effective drug safety monitoring system, and the power to then act promptly when safety concerns arise.

At a minimum, the Senate should get answers to some tough questions before they confirm Crawford. Will Crawford support more transparency in drug information, will he support a clinical trial registry and results database? Will he support a more independent and vigorous office of drug safety?

It appears now that unanswered questions about emergency contraceptives are slowing his confirmation process. The Senate needs to make sure Crawford and the FDA will not stymie real reform.

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