The FDA's pregnancy watch list.

The FDA's pregnancy watch list.

The FDA's pregnancy watch list.

Health and medicine explained.
Sept. 15 2006 2:01 PM

The Pregnancy Watch List

On risk, the FDA misses the boat.

This week, the Wall Street Journal reported ($) on restrictions that the Food and Drug Administration has placed on the use of an important acne drug by pregnant women. We're not talking about a few pimples—the drug, Accutane, is the most effective treatment for the kind of acne that causes scarring disfigurement and is often used as a last resort. It also, however, causes serious birth defects in the babies of women who get pregnant while taking it. Despite long-standing warnings about the malformations that the drug can cause in the fetus, about 200 pregnancies occur in American women taking Accutane every year.

Last year, the FDA started a specialized program that closely monitors both women on the drug and the doctors who prescribe it. Because it is mostly adolescents who get acne, and adolescent pregnancies tend to be accidental, the steps the FDA has taken seem appropriate at first glance. But however well-intentioned its efforts, the FDA is erecting a barrier to care and missing an opportunity to hit a public-health home run. The awful side effects of Accutane should be an opportunity to help women avoid unplanned pregnancies, not punish them by decreasing access to a drug that can cure a serious condition.

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Almost 50 percent of pregnancies in the United States are unplanned—the highest rate in the developed world. But the FDA's program for monitoring Accutane, called iPLEDGE, does not educate women about how to effectively prevent pregnancy. Not all contraceptives are equal—efficacy rates for different methods range between 70 percent and 99 percent. The FDA literature doesn't discuss that. The program insists that reproductive-aged women use a combination of two contraceptives from a preapproved list (which, by the way, actually excludes one of the most effective methods of contraception, an IUD), without addressing the general importance of using effective birth control at all times if a woman wishes to avoid pregnancy. The FDA's message is that contraception goes with Accutane, not that contraception goes with preventing unwanted pregnancies. I wonder what the rate of unintended pregnancies is among young women who have just gone off their Accutane.

Women who wish to take Accutane must register with an FDA database, and their doctors must verify negative pregnancy tests before, during, and after use of the drug. Doctors also are required to register each new Accutane prescription they write. As a result, the Journal reports, prescriptions for Accutane have fallen by nearly half in the last year. The FDA's monitoring efforts thus have had the effect of decreasing women's access to the best drug for curing a disfiguring condition.

And let's be realistic about the magnitude of the problem the FDA seeks to prevent. Birth defects are horrible, yes, but 200 pregnancies do not equal 200 babies. Accutane causes miscarriages, too, and surely many, if not most, of the pregnancies that continue are aborted (aha—maybe this helps explain the government's concern). Prevention of birth defects is important whenever possible. But it does not necessarily call for alarmist, over-the-top regulation. In the Journal article, the deputy director of the FDA said of Accutane, "This is a pretty toxic drug, it's not Tylenol." Hmmmm. Accutane is responsible for the potential complication of 200 pregnancies per year. Tylenol is responsible for 458 deaths per year and for 50 percent of cases of acute liver failure. You do the toxicity math.

Of course, reproductive-aged women using Accutane should use birth control. So should all sexually active women who are not trying to get pregnant. Pregnancy is risky business for women to begin with, and their babies face increased risks when a pregnancy is unplanned. Neural tube defects—spina bifida and other problems with the closing of the spinal column—complicate between 0.1 percent and 3 percent of all pregnancies. Since the spinal column closes in the first month of pregnancy, many instances of these defects can be prevented by taking folic acid before conception occurs. Women who are actively trying to get pregnant may know that; those who aren't probably won't take the necessary supplement. Children born after an unplanned conception are also at greater risk of being born at a low birth weight, of being abused, and of not receiving sufficient resources for healthy development. Being unplanned is a risk on its own, separate from poverty and other socioeconomic factors. The FDA doesn't have a registry for those risks. Nor should it. Women should be educated about how to have healthy outcomes, not tracked ahead of time because of the possibility that they may not.

The lesson of the Accutane story should be that unplanned pregnancies remain a big problem in our country, a problem our government has not effectively addressed. Access to contraceptive care has been a persistent battle. The Equity in Prescription Insurance and Contraceptive Coverage Act, which would prohibit health insurance plans that provide prescription drugs from excluding coverage of FDA-approved prescription contraceptives, has been introduced and reintroduced in the U.S. Senate since 1997—and has gotten nowhere. Meanwhile, partially as a result of spotty insurance coverage of birth control, women spend 68 percent more than men on health care in the United States. Two-thirds of U.S women of childbearing age rely on employer-related health plans, yet 49 percent of large group plans do not routinely cover any contraceptive method. Medicaid generously covers pregnancy-related needs but is much less generous when it comes to contraception.

Expanding Medicaid to cover all contraceptive needs would reduce the number of unplanned pregnancies and abortions. It would also lower federal spending on health care, because contraceptives are cheaper than children. With all this in mind, the prevention of 200 unplanned pregnancies seems like drop in the bucket. And it is.

Courtney A. Schreiber is an assistant professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine.