Today, along with four others, I testified before the President’s Council of Advisors on Science and Technology, popularly known as PCAST. The topic: the administration’s failure to follow the law and allow over-the-counter access to Plan B emergency contraception.
Last month, Department of Health and Human Services Secretary Kathleen Sebelius shocked scientists and public health advocates by ordering the Food and Drug Administration (FDA) to reverse its science-based decision to allow access. The move was unprecedented: never before had an HHS secretary overruled a decision of the scientists and an independent scientific advisory committee at FDA.
It’s important to note that the law requires FDA to approve drugs that are safe and effective, and they must rely solely on the best available scientific information to make that determination. Not politics, not economics, and not the desires of special interests–just science. That is what keeps Americans safe while allowing access to life-saving medications.
In reviewing the secretary’s memorandum to the FDA and FDA Commissioner Margaret Hamburg’s matter-of-fact response, it is clear that the FDA was in strong disagreement with the secretary’s move. In a December 2011 New England Journal of Medicine Perspective piece, three reproductive health experts wrote, “Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls.”
HHS, notably, is one of the many agencies that has been silent on scientific integrity, despite White House guidelines that require it to develop a scientific integrity policy. It’s time for HHS to publicly release its policy for public comment, and if it doesn’t do so immediately, the White House should step in.
My testimony is below. The webcast of the event will soon be available.
“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.
“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.
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