FDA and the “Morning-After Pill”

Democrats yesterday criticized the FDA’s handling of Barr Pharmaceuticals’ emergency contraception drug (aka “morning-after pill”), in connection to Bush’s nomination of Lester Crawford as FDA commissioner. It would be easy to point out the irony of Democrats questioning the FDA’s caution in this case while also (presumably in the same press conference) criticizing the agency for safety problems that have come up with FDA-approved drugs, but I’d rather look more closely at the issues surrounding emergency contraception.
The drug at issue here is levonorgestrel, marketed under the brand name “Plan B” (which seems to me an unfittingly glib moniker, but I digress). It is already available by prescription, but Barr is seeking permission to sell it over the counter in pharmacies. The motivation for going OTC is clear–Plan B must be taken within 72 hours of unprotected sex, and the sooner it is taken the more effective it is. Removing the necessity for obtaining a prescription from a doctor will allow women faster access to Plan B.

The concern about making Plan B available OTC is also clear–significantly altering the function of a major biological system is not something to be done lightly. This is not a cold medicine. Furthermore, standard birth control drugs contain a much lower dose of hormones than Plan B, yet require a prescription. And, of course, there’s the concern that women may be more likely to engage in unprotected sex if this sort of “safety net” is readily available. (Note: the OTC product would be available to females 16 and older. Girls 15 and under would still require a prescription, though it’s easy to imagine that their older friends might acquire it for them.)
Central to the ethical questions about Plan B is the question of whether it is truly contraceptive or, at least in some cases, abortifacient. Unbiased data on this question is difficult to find. Pro-life groups highlight the likelihood that Plan B and similar drugs prevent the implantation of a fertilized egg (examples here and here). Other resources highlight the claim that the drugs can prevent ovulation or fertilization, yet still mention the possibility that they prevent implantation. Even the Plan B website admits this possibility, though they stress that Plan B “is not an abortifacient.”
Coming back to the FDA, then, I agree with Democrats that the agency should not be including political considerations in their decisions. The FDA’s mission is to ensure the safety, efficacy, and purity of medicines. If emergency contraception–even abortifacient drugs–are safe and effective, the FDA should approve them and it will be up to Congress and state legislatures to ban the drugs or not. (Just as some states have restricted cold and flu medicines to fight methamphetamine production.) There are real safety questions with at least some of these mediations, however. For instance, in safety testing of the first 2100 American women to take RU-486, four bled enough that they needed blood transfusions. That is slightly less than a 0.2% occurrence rate, but with such a potentially life-threatening side effect, that’s huge.