Judge Slams FDA for Delaying Emergency Contraception to Girls under 17

Monday, April 08, 2013

A federal judge last week blasted the Obama administration for playing politics with women's health. Judge Edward Korman concluded that the decision of Health and Human Services (HHS) Secretary Kathleen Sebelius to overrule a Food and Drug Administration (FDA) determination expanding over-the-counter (OTC) access to emergency contraception was “arbitrary, capricious and unreasonable.”


At issue is the contraceptive medication Levonorgestrel, a synthetic hormone formerly marketed as “Plan B” and now sold in generic versions. If taken soon after intercourse (ideally within 24 hours), it prevents fertilization and hence pregnancy. Available by prescription since 1999, and OTC for 17-year-olds since 2009, in December 2011 Levonorgestrel was approved for OTC availability to “all females of child-bearing potential.”


As FDA Commissioner Dr. Margaret Hamburg explained at the time, an expert panel of pediatricians and ob-gyns recommended the change because their review “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, that the product would not protect them against sexually transmitted diseases…[and] that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.”


Leading medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics, supported the FDA decision.


Although Sebelius claimed she based her veto decision on science because of the manufacturer's failure to study the drug's safety for girls as young as 11 (about 10% of whom are physically able to bear children), her veto was widely seen as a political decision made less than a year before the 2012 election. At the time, Republican candidates for president were criticizing Obama's positions on both contraception and abortion, and were ready to describe OTC access as proof that the president supported sexual activity among adolescent girls. As a former HHS official told The New York Times, Sebelius was sincerely concerned how the drug would affect young girls, but was also being politically pragmatic.


That political pragmatism, however, came at the cost of sound science and lawful rulemaking, according to Judge Korman, who concluded that “the secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent.” Appointed by President Reagan in 1985, Korman squarely rejected the rationale behind the administration veto.


“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. Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”


Sharpening his critique to a razor's edge, Korman accused the administration of acting in “bad faith” and stated that “the F.D.A. has engaged in intolerable delays in processing” the request for OTC access, which “could accurately be described as an administrative agency filibuster.”

-Matt Bewig


To Learn More:

Plan B: Court Fixes Obama’s Morning-After Misstep (by Geoffrey Cowley, MSNBC)

Judge Chucks Plan B Restrictions as Product of Political Pressures (by Barbara Leonard, Courthouse News Service)

Judge Strikes Down Age Limits on Morning-After Pill (by Pam Belluck, New York Times)

Tummino v. Hamburg (by Hon. Edward Korman) (pdf)

Pennsylvania University Offers Morning-After Pills in Vending Machine (by Matt Bewig, AllGov)

Health Secretary and FDA Clash over Morning-After Pill for Minors (by Noel Brinkerhoff, AllGov)


Leave a comment