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

By Chris Mooney | March 24, 2009 9:00 am

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.The FDA Needs a Plan B on Plan B

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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Comments (2)

  1. Excellent development. I was following the fate of Plan B since it was corrupted a long time back. Strange (actually not so strange at all) how both religion and myopic governments are constantly adept at taking away choices from people and imposing their own views on them. The Bush administration and evangelical religion basically had the same implications for personal freedom. Sadly one of them still persists.

  2. DenverAstro

    As most of us reason and logic based thinkers argree, the Bush administration will go down in history as a black stain on the progress of science in what is supposed to be, or should be, the most technologically advanced nation in the world. I can see that the new administration is slowly but surely undoing the damage but I sure wish it could go faster. I’m tired of being embarrassed by my government. Aren’t you?

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About Chris Mooney

Chris is a science and political journalist and commentator and the author of three books, including the New York Times bestselling The Republican War on Science--dubbed "a landmark in contemporary political reporting" by Salon.com and a "well-researched, closely argued and amply referenced indictment of the right wing's assault on science and scientists" by Scientific American--Storm World, and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. They also write "The Intersection" blog together for Discover blogs.For a longer bio and contact information, see here.

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