FDA s Plan B policy gets an F from HHS s Sebelius

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In an unprecedented move, Health and Human Services (HHS) Secretary Kathleen Sebelius has overruled a decision by the FDA to allow emergency contraception the morning-after pill to be sold over-the-counter to teenagers under 17.

Teva Pharmaceutical s Plan B One-Step morning-after pill reduces the risk of unintended pregnancy by 50 percent, if taken within 72 hours after unprotected sex although it is most effective when used within 24 hours. By requiring teenage girls to first obtain a prescription, Sebelius ruling reinforces a major barrier to girls' access to this drug, seriously hindering them from obtaining it in a timely manner and thereby reducing its efficacy.

The FDA wanted to remove any Plan B age restrictions, based on research showing that access to the morning-after pill does not increase a woman s likelihood to have unprotected sex, and that this drug is safe for use by girls as young as 11. Two studies reported that, when provided with Plan B, girls ages 11 to 17 were able to understand the package directions, and demonstrated that they could use emergency contraception safely and appropriately without the help of a physician. In fact, Plan B is safer than many other current OTC medicines, such as aspirin and other painkillers. While an overdose of any of these medications can have dangerous consequences, it is actually impossible to overdose on the morning-after pill. And any theoretical risk is far outweighed by the risk of an unplanned pregnancy in girls and young women.

Given the strong evidence supporting OTC access to Plan B, ACSH's Dr. Gilbert Ross opposes Dr. Sebelius s decision. There s absolutely no scientific or medical basis for her to overrule the FDA on this measure, he says. The result will be more teenage pregnancies and abortions, which directly contradicts the goals of those who are against allowing greater access to Plan B.

Yet ACSH's Dr. Elizabeth Whelan finds herself in agreement with the health secretary s ruling. I think a girl who is 11 or 12 years old, she says, is too young to be able to make this decision without discussing it with and getting guidance from her parents. ACSH s Dr. Ruth Kava doesn t disagree with Dr. Whelan on principle, but she observes that many girls in this situation may not actually be able to discuss the matter productively with their parents. Given this reality, she says, making Plan B accessible is the more pragmatic decision.