Over-the-Counter Plan B Strikes Back


One of the low points of Obama's first term was his administration's decision to overrule FDA experts and refuse to make over-the-counter emergency contraception—like Plan B—available to women under 17. Last Friday, a federal judge held that the action was not merely wrong on the merits, but illegal. If the decision is not overturned on appeal, women under 17 will (as they should) have the same access to emergency contraception that women over 17 have.

The deplorable policy implications of the Obama administration's response does not, in itself, constitute an argument that it was illegal. The opinion by Reagan-appointed District Court judge Edward Korman, however, makes a compelling legal case that the override of the FDA was illegal. The crucial factor underlying Korman's opinion is the question of whether the executive branch followed the appropriate procedures. Congress, for better or worse, has the broad authority to regulate the availability of drugs. If it chose to ignore the scienitific evidence and perversely choose policy goals that would make unwanted teen pregancies more common, it is probably free to do so. The executive branch, however, does not have the same discretion to make policy choices in this case. As Korman notes, under longstanding precedent "an irrational departure" from established agency procedures may be subject to overturning as being "arbitrary and capricious." The power to make the relevant policies were delegated by Congress to the FDA, and the scienitific judgments of the professionals at the FDA can be overriden by the political appointees of the executive branch only on scienitific grounds.  

Korman's case that Secretary of Health and Human Services Kathleen Sebelius's intervention to require prescriptions for women under 17 was "arbitrary and capricious" is quite persuasive. In the words of Salon's Irin Carmon, "Korman’s decision is a meticulous work of evidence, citing medical journals, sociological research, prior regulatory procedure." Under existing procedures, the intervention of the secretary was highly unusual, and to justify overturning the FDA such an intervention required a clear scientific basis. Instead, "the reasons she provided are so unpersuasive as to call into question her good faith." Korman is particularly devastating with respect to Sebelius's assertion that "the label comprehension and actual use studies submitted to FDA do not include data on all ages for which the drug would be approved and available over-the-counter." Since the only ages not covered by this study were girls under the age of 13, the justification lacks a rational relationship to the remedy, which denied over-the-counter access to young women between the ages of 13-16. For these ages, the evidence of Plan B's safety was extensive. The invocation of 11-year-old girls using Plan B by the Obama administration, Korman argues, is a specious argument that cannot possibly justify overriding the FDA's scientific findings:

This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed.

Sebelius did not merely intervene to impose a terrible policy, but did so in violation of established procedures. I hope that the Obama administration will admit its error and allow the decision to stand.


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