FDA advisers back approval of longer-acting pill

An advisory panel to the Food and Drug Administration voted unanimously Thursday that the agency approve a new contraceptive that effectively prevents most pregnancies up to five days after unprotected intercourse.

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 voted unanimously Thursday that the agency approve a new contraceptive that effectively prevents most pregnancies up to five days after unprotected intercourse.

On back-to-back 11-0 votes, the FDA Reproductive Health Drugs Advisory Committee found a single dose of ulipristal acetate to be both safe and effective in preventing pregnancy for up to 120 hours.

That's important because 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 ulipristal. It maintains its effectiveness throughout the five days it is effective, which includes the window during which women are most fertile.

That fills a vast need, Princeton economics professor James Trussell told the panel.

"I'll remind you that more than 1 million women each day in the U.S. who do not want to become pregnant have unprotected sex," he said. "That's 1 million women last night; 1 million women tonight."

But sometimes the story of one patient has more impact than vast numbers. So Sara Imershein, a Washington, D.C., obstetrician/gynecologist, told the committee about a patient of hers named Karen. She said Karen tried to refill her prescription for her birth-control pills before a long trip, but couldn't because her insurance plan said it was too early.

"While away, Karen used up her pills, and she and her husband switched to condoms as a back-up method," Imershein said. "But a condom failed. Karen called me as soon as she returned, and I immediately recommended an emergency contraceptive -- likely averting a pregnancy."

Criticism

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

"Women and predators will be enticed to use it beyond 120 hours, putting the woman at great risk of aborting an implanted embryo by any definition of pregnancy," she testified.

That's a reference to the fact that some people 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 scientific evidence that at the dose being recommended, ulipristal causes any kind of abortion. It pretty much only works by preventing ovulation, Archer said.

"I just don't think there's any element here that would allow me to say that this has abortifacient activity," he said.

Still, those opposed to the drug's approval also worry about its potential health risks, both to women and to the babies of women who do get pregnant despite taking it.

"Here they're considering approving a drug with very little safety studies known, and almost no safety data known about its use in pregnancy," said Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists.

Data

But Sandra Carson, an OBGYN from Brown University and chairman of the advisory panel, said she thought the sponsoring company, HRA Pharma, presented quite a lot of data.

"Of course, there can always be more," she said. "But the data is very reassuring. The drug has been approved in Europe, and there's not only data from clinical studies, but also data that's actually from Europe from routine clinical use. That's especially reassuring."

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.

"We've gotten used to emergency contraception," she said. "And I'm encouraged that we've matured beyond that."

One thing that might make it less contentious is the fact that this drug, at least for now, would only be available with a doctor's prescription. Copyright 2010 National Public Radio. To see more, visit http://www.npr.org/.

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