Administration Again Fails on Over-the-Counter Emergency Contraception
This article was amended at 10:16 am, Wednesday, May 1, to correct the date of the amended application by TEVA to the FDA. It was resubmitted in 2012, not 2011. See all our coverage of EC Over-the-Counter here.
Today, in a proposal that can best be described as adding insult to injury, the Food and Drug Administration (FDA) approved making emergency contraception (EC) available over-the-counter for teens and women ages 15 and up. This convoluted proposal from the Obama administration comes despite a court order in early April by U.S. District Court Judge Edward R. Korman to make EC available over-the-counter to all ages within 30 days of his decision. It comes from an administration which pledged to make science the cornerstone of public policy and instead has consistently flouted a wealth of accumulated evidence on emergency contraception. It also comes after several studies showing that current policy requiring prescriptions for some groups and not others has confused so many pharmacists that access to EC has been denied to many who were in fact legally eligible to obtain it quickly. In practice, the new policy will almost certainly perpetuate, not resolve, that confusion.
The battle to make EC available over-the-counter has gone on for over a decade and spanned both the Bush and Obama administrations. Judge Korman's ruling was issued in response to the Center for Reproductive Rights' (CRR) renewed lawsuitagainst the FDA seeking to expand over-the-counter access for all women to all brands of the morning-after pill, including Plan B One-Step and Next Choice. The most recent CRR lawsuit was filed after Kathleen Sebelius, secretary of the Department of Health and Human Services, overruled a 2011 FDA decision to make emergency contraception available over-the-counter to all ages, underscoring that the Obama administration, like its predecessor, has difficulties dealing with the realities of sex and pregnancy prevention.
The administration's newest plan is to make EC available over-the-counter to individuals ages 15 and up, but still require prescriptions for those under age 15. While pharmacies can stock it in the family planning section of main store shelves, people seeking to buy EC will have to show identification with a birth date to a cashier. The plan comes after approval this week by the FDA of an amended application submitted by Teva, the manufacturer of Plan B One-Step, to allow OTC sale to those ages 15 and over, after an earlier request to do so had been denied by FDA in December 2011. The amended application was in any case superceded by the scientific evidence that led the FDA to rule in 2011 on making emergency contraception available OTC to all ages, the decision that was, as noted above, subsequently overturned by Sebelius. So in using the approved Teva application as the reason for this newest decision, the FDA is essentially reversing itself and ignoring the science on which its 2011 decision was based. Confused yet? Me too. It's a complete circus, and I have no doubt that leadership at the FDA, which tried to make evidence-based policy in 2011, came under pressure from the White House to find the "fix" it announced today.