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Remembering--and Reversing--The FDA's Disastrous Move on Plan B

The Plan B emergency contraception saga reveals the clash between political agendas and scientific integrity in FDA decision-making.

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I and many others wrote about the FDA's Plan B emergency contraception debacle when it happened back in 2004. The saga is just one of many instances, related in The Republican War on Science, of how Christian conservatives have turned to using "scientific" argumentation to achieve their desired moral and political ends--even if most or all reputed authorities consider their claims bogus.

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In the case of Plan B, the bogus claims revolved around an alleged lack of data on how adolescent girls would use the drug; and they were centrally voiced by one W. David Hager, a Christian right gynecologist and the author of As Jesus Cares for Women who had been placed on the FDA's Reproductive Health Drugs Advisory Committee. The politicized Bush FDA was busy creating unique regulatory and scientific hurdles to prevent the approval of Plan B for over-the-counter availability, and Hager helped provide the "scientific" basis. Granted, he didn't convince his scientific peers on the advisory committee that his worries had merit, but in Bush's FDA, he didn't have to. The ultimate Plan B decision was highly irregular in numerous respects, not least them being that an FDA official, Stephen Galson, overruled the nearly unanimous scientific advisory committee as well as his expert staff in rejecting the Plan B over-the-counter application. Instead, the FDA essentially went with Hager's minority view. I bring this up because all of these points have now been reaffirmed in court: See here for details. The U.S. District Court for the Eastern District of New York has ruled that the Bush FDA acted in an "arbitrary and capricious" manner on Plan B and demanded that it reconsider its decision. As the judge put it regarding the Plan B case:

These political considerations, delays and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use.

You can read the Washington Post report on this here. And you can bet an Obama FDA will go a very different way on Plan B in the near future. Little by little, the greatest highlights of the Bush "war on science" are being reversed….

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