Emergency contraception, also known as the “morning after pill” or Plan B, has become an important tool for many college women to help prevent unplanned pregnancies. Effective if used up to 72 hours after unprotected intercourse, Plan B is the first progestin-only emergency contraceptive to be approved by the U.S. Food and Drug Administration, according to the University Health Center, which prescribes the pill.
Emergency contraception is relatively available to women here at the University. But its status as a prescription drug limits other women’s access to this helpful form of birth control; in May 2004, the acting director for the FDA’s Center for Drug Evaluation and Research rejected an attempt by the pill’s manufacturer to make Plan B available over-the-counter, citing safety concerns.
Yet this month, the Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report that the FDA’s decision ran counter to accepted protocol. We are pleased by this revelation, and we hope it will lead to the FDA to make Plan B more accessible to women everywhere.
The report outlines several disturbing and “unusual” aspects of the FDA’s decision, indicating that certain FDA officials’ personal biases affected it. Foremost, the report states that the acting director’s decision was “novel” and different from the way 67 proposed prescription-to-OTC decisions were made by the FDA from 1994 to 2004. According to the report, he said his concerns about the potential for “risky behaviors among younger adolescents resulting from increased access to Plan B” influenced his decision to put the application on the fast-track to nowhere.
No contraceptives, either over-the-counter or prescription, approved by the FDA have age restrictions, according to the report. Further, the FDA has not required any pediatric studies for past approvals.
Moreover, some FDA staff allege that “they were told by high-level management that the Plan B OTC switch application would be denied months before staff had completed their reviews of the application.” Officials deny the allegations, with one saying the agency was “tending” or “thinking of going” toward rejecting the request.
High-ranking FDA officials who reviewed the application to change the pill’s status also did not sign the decision for Plan B because they disagreed with it, according to the report.
These deviations from standard policy suggest the acting director and others were personally invested in preventing teenage girls from engaging in sexual activity. Such moralistic logic has no place in a government regulatory agency.
We certainly condemn unprotected sex that physically or emotionally endangers either partner. But present rates of teen pregnancy and abortion suggest that young people continue to engage in unprotected sexual activity. Making Plan B more accessible might cause some people to engage in more risky behavior, but we shouldn’t prevent responsible teenagers, or anyone else, from having access to this contraceptive.