Commentary Law and Policy

The EC Decision: Where Were The President’s Science Advisors?

Susan Wood

Dr. Susan Wood discusses the recent misuse of science and data as part of the decision by the Secretary of HHS to overrule the scientific determination by the FDA Commissioner on bringing Plan B fully over the counter.

On Friday, January 6th, 2012, several public health experts addressed the President’s Council of Advisors on Science and Technology on the issue of Plan B One-Step® and the Obama administration’s refusal to let the Food and Drug Administration lift the age restriction from over-the-counter deliver of emergency contraception. Dr. Susan Wood is one among several experts whose testimony we have published.

See all our coverage of the Administration’s 2011 Emergency Contraception Reversal here.

Good afternoon Dr. Holdren and members of the Council. I would like discuss the recent misuse of science and data as part of the decision by the Secretary of HHS to overrule the scientific determination by the FDA Commissioner on bringing Plan B fully over the counter.

First, as a point of information, emergency contraception is not an abortion pill, but is just a higher dose of regular birth control pills to be taken within 72 hours to be effective in preventing pregnancy. It is very safe; safer than many other over-the-counter medicines like acetaminophen. It also is just adding one more reproductive health product onto the shelf along with condoms and pregnancy tests, which are available to all. There has been consensus of medical and scientific data and agreement among experts both inside and outside FDA since 2004 that Plan B emergency contraception should be over the counter to improve access and effectiveness. The data involved here are not complex nor involve controversial models. There is real agreement here, and it should have been a routine approval in 2004. This was blocked in 2005, and only partial approval allowed due to non-scientific reasons in 2006.

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Secondly, the FDA makes its scientific determinations based on the data, following the standards set in law and regulation. The Secretary, in overruling the unified opinion of the FDA as summarized in the statement by the FDA Commissioner, used a scientific, data-based rationale in her determination. This sets a new and, in my view, inappropriate precedent. I am quite concerned that any future Secretary may try to raise new (and unfounded) “scientific” rationales to block (or require approval of) any product that he/she disapproves of or supports. For example, controversial products such as those that may be developed from embryonic stem cell technology, HIV/AIDS vaccines for teenagers, or those that have the support or opposition of political/financial supporters. The determination of what medical products are approved for use is one that the public and health professionals must be able to trust and must be based on sound science.

Finally, I have a question for you. Given that the Secretary of HHS disagreed with the scientific analysis of the FDA professional staff and the FDA Commissioner, did the Council, OSTP or the President’s science advisor provide any technical or scientific advice on this matter, either to the Secretary or to the President? If not, what next steps will you take to ensure that in matters where science should indeed drive decisions (as in FDA’s product approval determinations), that accurate and fully supported science is the basis of these decisions, even when they are called controversial?

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