On Friday, January 6th, 2012, several experts addressed the President’s Council of Advisors on Science and Technology about the emergency contraceptive Plan B One-Step® and the Obama administration’s refusal to let the Food and Drug Administration lift the age restriction from the medication. The administration dismissed overwhelming scientific evidence showing Plan B’s safety, and the experts whose testimonies are published by Rewire raised questions about both the process and the politics behind the decision.
See all our coverage of the Administration’s 2011 Emergency Contraception Reversal here.
Good afternoon Dr. Holdren, Dr. Lander, and members of the council and thank you very much for the opportunity to speak with you. I want to begin by complimenting Dr. Jane Lubchenco on her scientific integrity leadership. NOAA recently released a scientific integrity policy with many excellent and I hope effective components. But sadly, only about a quarter of the relevant agencies have developed scientific integrity policies as required under White House guidelines and publicly released them.
When Secretary Sebelius overruled the FDA regulatory decision to approve the over-the-counter sale of Plan B, she demonstrated why these policies are so critical. While the good news is that political interference in science did not occur within the FDA as has happened in the past, it did happen. It is a curious coincidence that while FDA is quite far along on what appears to be a good policy, HHS has been relatively uncommunicative and has not released any draft policy.
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In her letter to the FDA commissioner ordering her to deny approval to Plan B, Secretary Sebelius used phrases like ‘based on my review’ and ‘my conclusion.’ This is exactly the situation which scientific integrity policies are created to prevent: namely, a non-scientist, political appointee overturning a decades-long process of scientific research and review both inside and outside of the FDA. This process has been upheld by many eminent scientific societies, such as the American Medical Association, and numerous scientists.
I would like to request that OSTP ask HHS to immediately release its scientific integrity policy and open a public comment period this month. If OSTP cannot do this, Dr. Holdren should ask the president to require HHS to do so. As Dr. Holdren has rightly pointed out, those agencies that have held public comment periods greatly benefited from the over 50,000 comments submitted thus far.