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 decision. 14 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. Read the rest of this entry »
