Battling Sciences Over at the Food and Drug Administration

Regular readers are probably familiar with the policy struggles related to the Plan B One Step morning-after birth control medication.  The most recent flash point relates to a decision last week by the Secretary of Health and Human Services to overrule a decision by the Commissioner of the Food and Drug Administration (FDA).  The Commissioner decided that it was acceptable to allow Plan B One Step to be purchased by those under the age of 17 without a prescription.  (Currently it can be purchased by those under the age of 17 with a prescription.)

The Secretary’s rationale was that the drug manufacturer did not provide sufficient information to justify eliminating the prescription requirement for all ages.  She states that studies submitted do not cover all ages for which the drug would be approved and goes on to cite “commonly understood” cognitive and behavioral differences between the youngest girls of reproductive age and older adolescent girls.  Her implication is that they youngest girls aren’t able to know how to use the drug effectively, and that is sufficient to keep the prescription requirement for those under 17.  The Secretary is ultimately responsible for fulfilling the obligations of the Federal Food, Drug and Cosmetics Act, which includes most of the FDA’s functions.  As a result, she can overrule an FDA decision, but this is rarely done.  The authority to do so does not, in my opinion, legally require a justification, scientific or otherwise.

The FDA Commissioner firmly, but politely, disagrees with the decision14 Senators have requested the Secretary explain her decision further, including the scientific data she is relying on.  This decision could get wrapped up into a court case focused on the original Plan B medication (One Step requires just one pill, not two).

The Secretary objected on scientific grounds, which framed this dispute as a scientific one.  But the choice to remove the prescription requirement isn’t just scientific.  Put another way, just because the drug is safe to use doesn’t mean it should be or (has to be) used.  Had the Secretary given her rationale for opting not to remove the requirement in non-scientific terms, the fight she finds herself in over this decision would likely be very different.  Had the Secretary opted to eliminate the prescription requirement for only those ages covered by the studies, the fight could have been quite different.  That she opted not to change anything about Plan B One-Step suggests other values and motives were behind the decision.  Which is fine, but I’d prefer people not try and find cover under other justifications.

Does this rise to the level of a misrepresentation of science, a violation of scientific integrity principles?  Well, there is no official Health and Human Services policy just yet, so the question is pretty academic.  There does appear to be a difference of interpretation over how young women could be to understand the function and appropriate use of the drug.  To me this strikes me more like a fight over what certain experiments mean rather than a misrepresentation of results.  Of course, had the Secretary not mentioned science at all in her decision, it would be a different argument entirely – what can or should trump science in policy decisions.  And the answer to that always depends.

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8 thoughts on “Battling Sciences Over at the Food and Drug Administration

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