HHS Secretary Overrules FDA Decision on Plan B

So-called “Plan-B” contraception is currently available for sale over-the-counter to women age 17 and older. Those younger than 17 may only obtain Plan B with a prescription.
Earlier this week, in response to a petition from Teva Pharmaceuticals, the manufacturer of Plan-B One Step, the Food and Drug Administration decided that the age limitations should be lifted.  A review by the Center for Drug Evaluation and Research concluded that the drug is “safe and effective” for use by adolescents and that younger women of child-bearing age were able to follow the product’s instructions and use it properly.  On this basis, FDA Commissioner Margaret Hamburg decided to make Plan-B One Step available without a prescription to all women of child-bearing potential.

On Wednesday, Health & Human Services Secretary Kathleen Sebelius overruled the FDA Commissioner. As Secretary Sebelius explained in a statement, “the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age,” largely because a significant percentage of eleven-year olds are capable of bearing children, and that there “are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”  Yesterday, President Obama said he supported the Secretary’s decision.

“I will say this, as the father of two daughters. I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine,” Mr. Obama said. The president’s daughters, Malia and Sasha, are 13 and 10. “I think most parents would probably feel the same way,” he said.

The usual suspects responded to the decision in the usual ways.  Reproductive rights organizations condemned the Administration’s decision.  Anti-abortion groups, which consider Plan-B an “abortifacient” because it can prevent a fertilized egg from coming to term, cheered the action.

Some of those critical of the Administration have characterized this decision as the triumph of politics over science.  So is this part of an Obama Administration “war on science”? No. Medical science should — and apparently did — inform the Administration’s decision, but a decision of this sort is not — and cannot be — a purely scientific one.  Science can illuminate the relevant trade-offs in a policy decision of this sort, but it does not determine how much weight should be placed on which concerns, such as whether it is more important to expand options and sexual autonomy for sixteen-year olds or “protect” girls who are only eleven or twelve.  No amount of scientific research will resolve this sort of dispute.

Reproductive rights groups are not angry because the decision represents the politicization of science, but because it places a limitation on the sexual autonomy of young women.  Similarly, those groups who support the decision are likewise motivated by something other than science.  Insofar as either group frames their objections in scientific terms, they obscure what is really at stake.  How much one values the ability of women and girls to control their own reproductive choices or believes in the ability of parents to influence if not control their daughters’ medical and sexual choices are relevant considerations, as is the weight one believes should be placed on the tail ends of the distributions — those most at risk of adverse effects or those girls of child-bearing age least able to make informed decisions  for themselves — or the relevance that Plan-B contraception can prevent the implantation of an already fertilized egg.  Science is relevant here, but it does not dictate the policy choice.

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