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Signs and Portents for EC OTC

Good news this month for women’s reproductive freedom! The widespread availability of emergency contraception (EC) is one of the main breakthroughs for women’s reproductive freedom in the past 10 years. So it’s even better to see that two advisory panels of the FDA recently voted to recommend that EC be made available over-the-counter without the need for a doctor’s prescription. You need to take EC within 72 hours of unprotected sex for it to prevent an unwanted pregnancy, and it gets less effective as time goes on; waiting around for a doctor and a pharmacy are not always a viable option. And there is no possible case to be made that it fails the FDA requirements for over the counter availability. Drugs are supposed to be made available OTC when (1) it is safe to use without a doctor’s supervision, and (2) the instructions are simple enough for self-medication based on the included instructions. That EC is safe, and doesn’t need close observation from a doctor, has been made obvious by all the scientific data and by the past 30 years of experience with both off-label uses of conventional oral contraceptives, and dedicated morning-after pills like Preven and Plan B. How about the simplicity of use? Well, here I’ll defer to Connie Schultz, who investigated the matter for the Cleveland Plain Dealer:

Still, . . . I thought it only fair that I try to decipher them for myself. The kind folks at Planned Parenthood of Greater Cleveland gave me a sample packet. To make it as difficult as possible, I imagined being a sexually active teenager who had abstinence-only sex education.

Would I, could I, understand what I was reading?

Instruction No. 1: Take the first tablet as soon as possible within 72 hours of unprotected sex.

Instruction No. 2: Take the second tablet 12 hours after you take the first tablet.

I think we women can handle it.

This is some great news. Unfortunately, it is only a promissory note for things to come: the FDA nearly always follows the recommendations of its advisory panels, but even if it is pretty sure that it will make EC over the counter, it is entirely unclear when it will do so. The Bush Administration’s FDA has a long record of foot-dragging on this issue, and it has taken two years of untiring activism to get to this point — quite in spite of the fact that the petition obviously meets all the relevant criteria. But the most recent events are a victory to be celebrated, and the light at the end of the tunnel is now in sight.

Now, here’s a question: chemically, Emergency Contraception is indistinguishable from a large dose of conventional oral contraceptives; dedicated EC drugs were developed based on a good 30 years’ worth of doctors’ off-label recommendations for using OCs. (If a patient needed emergency contraception, the doctor would offer a prescription for OCs and suggest that the patient take several at once.) So if safety and ease-of-use arguments show that EC meets the FDA’s requirement for over the counter drugs, then a fortiori they ought to show that the good old birth-control pill meets those requirements too. So while we work towards getting the government out of women’s medical decisions for the morning-after pill, why shouldn’t we also start thinking about a campaign to get the government out of women’s medical decisions for the conventional birth-control pill too?


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