Sex, Politics, and Morality at the FDA: Reflections on the Plan B Decision

On September 3, 2005, I resigned my consultant position with the Food and Drug Administration. I did this to protest the agency's August 26, 2005, decision to delay a final ruling on over-the-counter availability of Plan B, the emergency contraceptive, and I wasn't alone: Susan Wood, the FDA's assistant commissioner for women's health and director of the agency's Office of Women's Health, also resigned at about the same time. What in the world has been going on at the FDA?

Plan B consists of two relatively large doses of a single ingredient, levonorgestrol, a constituent of many birth control pills. Taken twelve hours apart within seventy-two hours after unprotected intercourse, the drug is about 75 percent effective in preventing pregnancy. Importantly for the question of over-the-counter availability, the drug's contraceptive efficacy decreases dramatically during this seventy-two hour window.

Plan B has been available by prescription since 1999. In April 2003, Women's Capital Corporation, which produces Plan B, filed an application with the FDA for approval of over-the-counter marketing of the drug. (Women's Capital Corporation later transferred ownership of the drug to Barr Laboratories.) As it often does in considering such applications, the agency then convened a joint meeting of its Nonprescription Drug and Reproductive Health Drug Advisory Committees (NDAC and RHDAC, respectively) in December 2003 to obtain independent expert opinion on the application. The briefing materials for the meeting were more extensive than usual; they weighed eighteen pounds.

During two days of intensive hearings and discussion, the committees carefully examined the pros and cons of over-the-counter availability; they also heard comments from several dozen members of the public, nearly all in support of approval. In the course of their deliberations, the committees voted twenty-eight to zero that the drug was safe (one member of NDAC commented that the single ingredient of Plan B, levonorgestrol, is the safest drug the committee had yet considered); they voted twenty-seven to one that consumers could properly use Plan B as recommended on the proposed labeling (as judged from the "actual use study" that was part of the sponsor's application); they voted twenty-eight to zero that women were unlikely to use Plan B as a regular form of contraception; and they voted twenty-seven to one that the actual use study data were generalizable to the overall population of over-the-counter users, including adolescents. At the end of the day, they voted twenty-three to four in favor of approval for over-the-counter availability (I was one of the twenty-three).

In sum, the committees agreed that Plan B met all of the FDA's criteria for over-the-counter availability: 1) an acceptable safety profile based on prescription use and experience; 2) a low potential for abuse; 3) an appropriate safety and therapeutic "index" (the ratio between the toxic and the therapeutic dose); 4) a positive benefit-risk assessment; and 5) demonstrable need for treatment of a condition or illness that is self-recognizable, self-limiting, and requires minimal intervention by a health care practitioner.

While all of that is true, the committees spent most of their time during the hearings considering several complex social, behavioral, and ethical issues—both benefits and side effects or "toxicities"—associated with over-the-counter availability of emergency contraception. FDA advisory committees do occasionally take up issues of that kind; in other meetings, for example, the NDAC struggled at length with the problem that acetaminophen, the active ingredient in Tylenol, is often used for suicidal overdose. But many of the issues raised in connection with the proposed over-the-counter switch of Plan B differed, both quantitatively and qualitatively, from the usual biological and clinical concerns raised by other over-the-counter switches. To start with, the proposed benefits for the switch of Plan B—and the primary explicit rationale for the over-the-counter switch application—were as much social, behavioral, and ethical as they were clinical. They included the likelihood that over-the-counter availability...