FDA should debate science, not morals

Last week, the Food and Drug Administration defied the near-unanimous recommendation of its… Last week, the Food and Drug Administration defied the near-unanimous recommendation of its own panel and rejected a move to make emergency contraceptive drug Plan B eligible for over-the-counter sales.

Plan B, a so-called “morning after pill,” can prevent pregnancy if taken up to 72 hours after intercourse. While right-wing opponents have called it an “abortion pill” and lobbied hard against its approval, Plan B is not the same as the controversial RU-486, which ends a pregnancy that has already begun. It’s actually two high doses of a birth-control hormone that prevents ovulation, and, as the Washington Post noted, means fewer abortions, not more.

The FDA denied that politics played any role in the rejection, and Acting Director Steven Galson said that the door was still open to approve the drug for over-the-counter purchase in the future. Galson said concerns were primarily about lack of data in the 14-to-16-year old demographic, data the drug’s developer said could be available in a few months.

All of which is fine. For now.

But if Barr Laboratories, the company that develops Plan B, comes out with independent research that says the drug is safe and effective for all ages, or if Barr makes a prescription mandatory for women under the age of 16, then the debate should be over and Plan B approved for over-the-counter sale.

The FDA is a regulatory agency, but it is not there to regulate morality. It is there to determine if drugs are safe and effective, which Plan B is, according to all the data we have. Mandating a prescription for a drug that has a narrow window of effectiveness all but defeats the drug’s usefulness, and, in this case, means more unwanted children or more abortions.

Presidential candidate John Kerry attacked the decision as being the product of politicking and election-year pressures. While it might be too early to level that charge, the voting members of the FDA should be ready, as soon as necessary, to vindicate itself by making a sound decision based on safety, evidence and efficacy — not personal morals.