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FDA rejects over-the-counter Plan B

By now everyone's heard that Susan Wood has resigned from the FDA in protest over the agency's decision to indefinitely delay the approval of the OTC emergency contraceptive known as Plan B (levonorgestrel, the "morning-after pill").

Ordinarily I wouldn't have given this much thought, since I try to avoid the abortion issue whenever I can. It was only because the forceful denunciation of the FDA's decision (pdf) in the New England Journal of Medicine was so fun to read that I'm posting about this now. Not since Terri Schiavo have we had such a good demonstration of the political power wielded by social conservatives, even when they're totally out to lunch on the substantive arguments of the issue.

The arguments supporting FDA approval of this emergency contraceptive drug for over the counter availability are solid. The scientists on the agency's advisory committee voted overwhelmingly in favor of it. There's been a lot of hand-waving by the FDA about safety in younger women, and about the agency's authority to approve a drug for both prescription and OTC use by people in different age groups. The major arguments against Plan B, however, come down to two. First, that Plan B causes abortion, and second, that unrestricted access to Plan B by people younger than 17 would harm them in some way.

The first argument is weak on several levels. Most studies that I can find suggest that levonorgestrel prevents pregnancy by interfering with ovulation, not by preventing the implantation of a fertilized ovum (see, e.g. Croxatto et. al., Contraception 70 (2004), pp. 442-50; general discussion here). But even if, as groups like Concerned Women for America point out, we don't know the exact mechanism of action, it's hard to sympathize with their stance on this issue. To block access to a safe method of preventing unwanted pregancies because the drug might occasionally prevent implantation of a fertilized egg demonstrates the absurdity of the extreme anti-abortion position. An unwanted pregnancy can be profoundly harmful to an adolescent girl, to say nothing of the potential harm to the child. That the strict anti-abortionists would prefer these harms over the harm to an occasional fertilized egg that's prevented from implanting in the uterus is patently absurd. This kind of policymaking deserves the label "extremist."

The second argument, that access to Plan B without a prescription would harm women under 17, is equally weak. Wendy Wright of Concerned Women for America argues that OTC availability would increase rates of sexually transmitted disease, but I don't know how much credibility she should be given after she says things like this:

What's more, experts have found that men will frequently buy it, and some slip it to unsuspecting women. An age restriction would not hinder men who would buy the drug and give it to underage girls.

It is naive to assume any over-the-counter scheme for the morning-after pill would be effective. A 17-year-old could buy it for a 13-year-old girl. Or worse yet, a pedophile could purchase this drug for his victims.

This wingnuttery sounds like what we'd expect from someone who was profoundly afraid of people under seventeen having sex, and/or who deeply misunderstands the connection between the availability of a drug and the likelihood of criminal behavior.

We should be concerned about underage people getting sexually transmitted diseases, and we should be concerned about pedophilia, but the connection between these things and Plan B is just too speculative. What's not speculative is that Plan B prevents unwanted pregnancy, and that unwanted pregnancy harms people, often in a very profound way.

The FDA can't do its job properly if it's being pushed and pulled by politicians who ought to be debating social policy in other arenas. If Congress doesn't want Plan B approved, they ought to legislate to that effect. Leaning on an agency that's charged with ensuring drug safety will only diminish the agency's credibility, and in the post-Vioxx era, it doesn't have a lot of excess credibility to play around with.

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