At Law: Plan B: Politics and Values at the FDA, Again

Abstract

Plan B is an emergency contraceptive that the U.S. Food and Drug Administration approved for prescription use in 1999. In 2003, a company called Barr Pharmaceuticals submitted to the FDA an application to switch Plan B from prescription to over-the-counter (OTC) status. At a joint meeting late that year, the FDA's Nonprescription Drugs Advisory Committee and Advisory Committee for Reproductive Health Drugs recommended that the agency approve the application. But in a May 2004 letter, FDA officials notified Barr that the application was approvable at this time. The letter, signed by the acting director of FDA's Center for Drug Evaluation and Research, Steven Galson, said that the company had failed to supply data establishing that Plan B would be safe for younger women using it without professional supervision. A drug can qualify for OTC status only if it confers benefits that outweigh its risks, and the manufacturer tries to show that it does by offering evidence of acceptable product performance in a study of actual consumer use. Label comprehension is also a central concern. Because consumers will take the drug without a clinician's guidance, the label must include clear instructions for safe and effective use. (1) Barr's application to sell Plan B without a prescription relied primarily on a study of 585 women. Though the data overall met the OTC standards, the sample size for young adolescents was inadequate, Galson asserted: just twenty-nine subjects were under sixteen and none was under fourteen. Barr had also submitted an alternative (and novel) proposal to assign Plan B a dual status--OTC for women over sixteen and by prescription for younger women. But Galson denied this proposal because it was incomplete. The FDA letter described what Barr could do to gain approval for OTC status. First, it could furnish more data showing that young adolescents could use Plan B safely without professional assistance. Alternatively, it could submit a more complete application for dual status. The latter option would be more complicated, however. Barr would have to describe a satisfactory labeling, marketing, and education approach that took into account the different age groups and access routes for a dual status product. The FDA would also have to verify its statutory authority to approve a drug as prescription-only for some people and OTC for others. Although Galson denied that the agency was under political pressure to decide as it did, skeptics charged that Plan B had become a pawn in the presidential campaign. Groups supporting OTC status charged that the decision was actually motivated by the administration's quest to win votes in the November election. Conservative groups and members of Congress had opposed the switch, claiming that an easily available emergency contraceptive could promote unsafe sex among teenagers. They also said that OTC status would conflict with the administration's other policies favoring abstinence for teens. (2) But pro-choice and medical organizations argued that the data were more than adequate to support the switch. According to the existing data, Plan B reduces the pregnancy rate after unprotected sex from 8 percent to 1 percent. The drug is most effective when taken within twenty-four hours after intercourse, which is much easier to do if the drug has OTC status. Researchers have detected no serious side effects in women and no harm to children born to women taking the drug. Like several other contraceptives, Plan B fails to protect against sexually transmitted diseases, but OTC supporters cite studies indicating that women with convenient access to emergency contraceptives do not decrease their use of condoms. (3) Researchers say that Plan B may act in two ways to prevent pregnancy. One is by preventing ovulation and the other is by preventing the fertilized egg from implanting in the uterus. The latter possibility makes the drug objectionable to people who think it is wrong to terminate developing human life after conception. …