The Food and Drug Administration (FDA) rejected an application to the "morning after pill" Plan B available without a prescription, despite the nearly unanimous advice of its own panel of experts that the drug is safe for over-the-counter use. An FDA-appointed group of scientists, medical professionals, and consumer and industry representatives reviewed materials on the safety and effectiveness of Plan B. For a drug to be approved for over-the-counter use, a patient must be able to do three things without the intervention of a physician: diagnose the problem, treat the problem effectively, and understand the drug's label. Considering both product safety and the requirements for over-the-counter use, the advisory committee determined in a 23 to 4 vote that the drug was a safe and effective option for women. The decision was lauded by healthcare professionals as well as FDA staff members. In December, more than 70 medical and advocacy organizations signed a letter supporting the committee's recommendation to make Plan B available over the counter. In January, the Association of Reproductive Health Professionals (ARHP), representing more than 11,000 reproductive healthcare professionals, wrote FDA commissioner Mark McClellan to voice their support for the over-the-counter status of Plan B. Dr. Steven Galson, acting director of the FDA's center for drug evaluation, made an unprecedented move when he rejected the advice of the joint committee, the healthcare community, and FDA staff and wrote Plan B makers Barr Pharmaceuticals that the drug was "not approvable" for OTC sale. The FDA rejected the proposal on grounds that not enough research had been done on whether girls younger than sixteen would understand how to use the drug. According to The New York Times, Galson maintains that "the worst-case scenario" of the availability of Plan B without a prescription "is you've got a young couple and they would normally use a condom when they were having intercourse, but since they know they can run to the CVS to get Plan B, are they going to worry about that?" Even if Plan B required further studies, Dr. Galson could have deemed the drug approvable and still required that more information be provided. Rather, he chose took the stronger stance of deeming the drug "not approvable," which requires the company to reapply for over-the-counter status rather than simply produce the necessary information. As Dr. Galson told the New York Times, "We said that the shortcomings are so large that we are not able to go that intermediary step." The drug company plans to meet the hurdle put in place by the FDA and to resubmit its request for over-the-counter status. The ruling appears to require that Barr Pharmaceuticals do additional clinical trials as well as reapply for over-the-counter status, possibly delaying the appearance of Plan B on the shelves for years. The original application for over-the-counter status was likewise delayed; after it was filed in April 2003, FDA slated its ruling for February 2004, but delayed its decision until May for undisclosed reasons. Rather than allowing the easy access of a safe drug that could avoid 89 percent of unwanted pregnancies from occurring, the administration chose instead to play to the politics of its electoral base. Transcript of Advisory Board Meeting Briefing Information from Advisory Board Meeting, including findings from studies of Plan B's safety and effectiveness FDA's information on Plan B, including the letter of not approvable status