Women's Groups Outraged By Ruling On Morning-After Pill : Shots - Health News The Health and Human Services secretary overruled the FDA's opinion that the "Plan B" emergency contraceptive pill is safe and effective enough to be sold without a prescription — and without any age restrictions. Women's health advocates say the action reminds them of how the Bush administration treated the issue.

Women's Groups Outraged By Ruling On Morning-After Pill

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Health and Human Services Secretary Kathleen Sebelius has overruled the scientific opinion of the Food and Drug Administration on a morning after contraceptive pill. It had been deemed safe enough to be sold without a prescription and without any age restrictions. But yesterday's ruling means teens 16 and younger will still need a prescription. NPR's Julie Rovner reports on a political debate stretching back years.

JULIE ROVNER, BYLINE: In 2003, two FDA advisory committees voted overwhelmingly to make the morning after contraceptive bill, known as Plan B, available over the counter to women of all ages.

DR. ATSUKO KOYAMA: It's always been known to be quite safe. There are no contraindications for its use at all. If someone is already pregnant, it does not cause an abortion.

ROVNER: Atsuko Koyama is a pediatrician and emergency room doctor at the Boston Medical Center. She says the teenagers she sees in her ER are quite capable of knowing what to do with the medication.

KOYAMA: I have had patients who are 15, 16 years old, who come into the ER asking for Plan B, so, you know, they're taking responsibility for their health and their future.

ROVNER: But the FDA didn't follow its advisors' recommendations back then, which was unusual. Many women's health groups and members of Congress charged that the Bush administration's decision was politically motivated. Susan Wood, the FDA's assistant commissioner for women's health, ended up quitting her job in disgust.

SUSAN WOOD: That was part of a series of blockages that occurred, which clearly was showing FDA being overruled and not being allowed to do its job and make its decisions based on their interest in the public health and in women's health.

ROVNER: Finally, in 2006, the FDA decided to make the pill available without a prescription to those 18 and over, but still require younger teens to see a doctor first. A judge later lowered to 17 the age at which a prescription would not be necessary. But the impact of that split approval means that the product isn't really available over the counter, even for adults, Wood says, because they still have to ask for it and show ID. And with this latest decision, that won't change.

WOOD: For all women of all ages who are in an urgent situation, they still have to go find an open pharmacy and ask permission of the pharmacist or the pharmacy clerk to have access to this product.

ROVNER: It was that hope of making emergency contraception much easier to get that has outraged, not just people like Susan Wood, but women's health advocates like Kirsten Moore. She's president of the Reproductive Health Technologies Project.

KIRSTEN MOORE: I was in the East Room of the White House in March 2009 when the president signed an executive order saying this administration was committed to restoring scientific integrity to the policymaking process. And that commitment just went up in smoke today.

ROVNER: Not everyone is unhappy, however. Conservative groups have long favored keeping the age restrictions in place. Jeannie Monahan is with the Family Research Council.

JEANNIE MONAHAN: So I think that most reasonable people will agree that a young girl who's sexually active, seeing a medical professional is a positive thing.

ROVNER: No one can remember a case before of an HHS secretary stepping in to overrule a scientific opinion made by FDA. And now the administration is facing yet another contraception related-decision, whether to back away from new rules requiring most religious employers to include contraception in their health insurance plans. Catholic leaders have already met personally with President Obama to lobby for the change. Kirsten Moore says she's no longer confident the administration will fight for its own rules.

MOORE: When there's political pushback, they back down.

ROVNER: The decision on the contraceptive rules is expected any day.

Julie Rovner, NPR News, Washington.



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