Tuesday, November 15, 2005

I'm shocked. Shocked that there is political interference at the FDA

A foolish consistency is the hobgoblin of little minds, adored by little statesmen and philosophers and divines. And bureaucrats with a political agenda—The General Accounting Office has reported that the Food & Drug Administration decided to block over-the-counter sale of Plan B, the “morning-after pill,” before the study of its safety and efficacy was complete. I know you find that hard to believe but here is the text.

Then-FDA Director Mark B. McClellan told the FDA staff the request to sell the pill without a prescription would be rejected and he then signed what is called a “not approvable letter.” Other top supervisors had to co-sign after the administrators below them refused. The GAO report called McClellan’s actions “novel,” not the way the FDA usually handles these issues. The explanation, of course, is that McClellan was one of the political hacks put in place by the Bush administration because he was a favorite of the anti-abortion crowd. This, of course, makes no logical sense. If you are against abortions (a thoroughly reasonable decision if allowances are made for the life and safety of the mother) you would be in favor of Plan B because it makes abortions less frequent. The pill itself is a contraceptive and does not cause an abortion.

FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told us that they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told us that they were told by the Acting Deputy Commissioner for Operations and the Acting Director of CDER, after the Plan B public meeting in December 2003, that the decision on the Plan B application would be not-approvable. They informed us that they were also told that the direction for this decision came from the Office of the Commissioner. … Both office reviews were not completed until April 2004.

The application by Barr Laboratories, the manufacturer of Plan B, was opposed by 49 members of Congress and many social conservative groups and the FDA surrendered, with politics trumping science again. The excuse given was that the safety of Plan B in teenagers had not been established. In fact, it has. The manufacturer has now asked that it be sold to women over the age of 17, and the FDA is sitting on that as well.

In response, the FDA disagreed with the conclusions and criticized the study for not paying sufficient attention to its input. But Susan F. Wood, former assistant FDA commissioner for women’s health, who quit over this deal, said the GAO report was exactly correct and the reason she left. The GAO study did not go into White House involvement in the decision.

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