Last week, a judge ordered the FDA to make emergency contraception pills available over the counter, with no age restrictions, capping a long and frustrating legal battle to increase access.
Versions of levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) are expected to be made available without restriction within 30 days, but it’s not clear whether there will be some administrative interference. The FDA might decide on new labeling or to limit the forms of emergency contraception made available. There is also the possibility that the decision will be appealed.
OTC access for all ages is essential because most emergency contraception pills are most effective when used as soon as possible, and time, distance, money, and privacy can be serious barriers, especially for teenagers, to obtaining and filling a prescription in time to prevent pregnancy.
The push to make emergency contraception pills (also known as morning-after pills) available to all ages without a prescription suffered a major setback in 2011, when HHS Sec. Kathleen Sebelius blocked the FDA’s decision to remove the age barrier. Since 2009, emergency contraception has been available without a prescription for anyone age 17 and older.
Sebelius’s objections focused on the idea that young girls would use EC in unsafe ways. Susan Wood, A former director of the FDA’s Office of Women’s Health who in 2005 resigned over political delays around emergency contraception, rejected Sebelius’s claim that more data was needed on safety and label comprehension, noting that “this type of age restriction, and worries about the use of medicines by teenagers, have not been applied to other products.”
U.S. District Judge Edward R. Korman, in reversing the FDA’s decision to deny a citizen petition for all-ages access, seems to agree that the “What about 11-year-olds?” objection is merely a smokescreen. From the memorandum:
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.
Korman characterized Sebelius’s actions as “obviously political” and “arbitrary, capricious, and unreasonable,” and wrote:
Nevertheless, even with eyes shut to the motivation for the Secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith. While the Secretary has strung together three factual statements in her memorandum to Commissioner Hamburg, she has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.
While we’re celebrating the judge’s ruling, we should also keep in mind the fact that President Obama is still praising Sebelius’s unprecedented, access-denying interference and overriding of the FDA’s scientific review process.
- The Top 11 Zingers From the Emergency Contraception Decision – Sharona Coutts at RH Reality Check
- Emergency Contraception and Moral Panic: Dissecting the Newest Misinformation Campaign – Sidra Zaidi at RH Reality Check
- Doctors Celebrate Plan B Ruling – Physicians for Reproductive Choice
- Federal Judge Orders FDA to Broaden Access to Emergency Contraception – Center for Reproductive Rights; includes a great timeline showing milestones in the struggle for OTC access for more than a decade.
Background information from Our Bodies Ourselves: