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FDA Advisers Back Approval Of Longer-Acting Pill

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FDA Advisers Back Approval Of Longer-Acting Pill


FDA Advisers Back Approval Of Longer-Acting Pill

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  • <iframe src="" width="100%" height="290" frameborder="0" scrolling="no" title="NPR embedded audio player">
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Women may soon be able to replace the morning-after pill with the five-day-after pill. An advisory panel to the Food and Drug Administration has unanimously recommended the agency approve the new contraceptive. NPR's Julie Rovner reports on the new pill and the controversy.

JULIE ROVNER: The current drug of choice for post-sex contraception, called Plan B, only works for three days, and it gets less effective the more time goes by. That's not the case with this new drug called ulipristal.

It maintains its effectiveness even over the five-day window women are most fertile. That fills a vast need, Princeton economics Professor James Trussell told the FDA advisory committee on reproductive drugs yesterday.

Professor JAMES TRUSSELL (Economics, Princeton): I'll remind you that more than one million women each day in the United States who do not want to become pregnant have unprotected sex. That's one million women last night.

ROVNER: Despite the unanimous endorsement of the panel, however, there were naysayers in the room. Among them were antiabortion activists like Wendy Wright, president of Concerned Women for America.

Ms. WENDY WRIGHT (President, Concerned Women for America): Women and predators will be enticed to use it beyond 120 hours, putting the woman at greater risk of aborting an implanted embryo by any definition of pregnancy.

ROVNER: That's a reference to the fact that some women believe life begins at fertilization, and that any contraceptive that prevents a fertilized egg from implanting in a woman's uterus is therefore an abortion. Wright and other abortion opponents also point to the fact that the new drug is from the same chemical class as the actual abortion pill, RU486.

But during the hearing, several medical experts, including obstetrician/gynecologist David Archer of the Eastern Virginia Medical School, said there's simply no evidence that at the dose being recommended, ulipristal causes any kind of abortion. It pretty much only works by preventing ovulation.

Dr. DAVID ARCHER (Ob/Gyn, Eastern Virginia Medical School): I just don't think there is any element here that would allow me to say that this has an abortifacient activity.

ROVNER: Still, those opposed to the drug's approval, like Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists, also worry about the drug's potential health risks, both to women and to the babies of women who do get pregnant despite taking it.

Ms. DONNA HARRISON (American Association of Pro-Life Obstetricians and Gynecologists): Here, they are considering approval of a drug with very little safety studies known, and almost no safety data known about its use in pregnancy.

ROVNER: But Sandra Carson, an Ob/Gyn from Brown University and chairman of the advisory panel, said she thought the company, HRA Pharma, presented quite a lot of data.

Dr. SANDRA CARSON (Ob/Gyn, Brown University): Of course, there can always be more. But the data is very reassuring. The drug has been approved in Europe, and there's not only data for - that has been conducted during clinical studies, but there's also data that's actually from Europe in routine clinical use.

ROVNER: In fact, the drug is already being marketed in 22 different countries. The next step is for the full FDA to decide whether or not to approve ulipristal. It usually - but not always - follows the recommendations of its advisory panels.

Of course, the last time the FDA was called on to decide about emergency contraception, during the administration of George W. Bush, it became a very political fight over whether to allow the sale of Plan B without a prescription. Carson says she's confident that won't happen again.

Dr. CARSON: We've gotten used to emergency contraception. And I'm encouraged that we've matured beyond that.

ROVNER: It might make it less contentious that this drug, at least for now, would only be available with a doctor's prescription.

Julie Rovner, NPR News.

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