FDA panel weighs longer-working option to 'morning-after' pill
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WASHINGTON -- A French drug company is hoping to offer American women an option their European counterparts already have: a pill that works long after "the morning after."
The drug, dubbed ella, would be sold as a contraceptive -- one that could prevent pregnancy for as many as five days following unprotected sex. But the new drug is a close chemical relative of the abortion pill RU-486, raising the possibility that it could theoretically be used to induce abortion, by making the womb inhospitable for an embryo.
The controversy sparked by that ambiguity will force a panel of federal advisers scheduled to consider endorsing the drug next week to grapple with a host of thorny issues.
The last time the Food and Drug Administration vetted an emergency contraceptive -- Plan B, the so-called "morning-after" pill -- the decision was mired in debate over such fundamental questions as when life begins and the distinction between preventing and terminating a pregnancy.
Ella is raising many of those same politically charged questions -- but more sharply, testing the Obama administration's pledge to keep ideology from influencing scientific decisions.
Plan B, which works for as long as 72 hours after unprotected sex, was eventually approved for sale without a prescription, although a doctor's order is required for girls younger than 17. The new drug promises to extend that period to at least 120 hours. Approved in Europe last year, ella is now available as an emergency contraceptive in at least 22 countries.
Ella is being welcomed by many U.S. advocates for family planning and reproductive rights. But opponents of the new drug argue that the French company and the FDA would be misleading the public by labeling ella as an emergency contraceptive. Its chemical similarity to RU-486 makes it more like the controversial abortion pill, which can terminate a pregnancy at up to nine weeks, they say.
RU-486 has soared in popularity since approval 10 years ago in the United States, raising the possibility that ella -- or ulipristal acetate -- might become ubiquitous in American women's medicine cabinets. "With ulipristal, women will be enticed to buy a poorly tested abortion drug, unaware of its medical risks, under the guise that it's a morning-after pill," said Wendy Wright, of Concerned Women for America, which led the battle against Plan B.
Plan B prevents a pregnancy by administering high doses of a hormone that mimics progesterone. It works primarily by inhibiting the ovaries from producing eggs. Critics argue that it can also prevent a fertilized egg from implanting in the womb, which some consider equivalent to an abortion, making it a continuing focus of controversy.
RU-486 works by blocking progesterone's activity. Because progesterone is needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo, RU-486 can prevent a fertilized egg from implanting and dislodge growing embryos.
Its chemical similarity raises the possibility that ella -- perhaps if taken at elevated doses -- may do the same thing, though no one knows for sure, because the drug has never been tested that way. Opponents of the drug are convinced it will.
"It kills embryos, just like the abortion pill," said Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists. "It's embryotoxic."
Critics fear that women who do not realize that they are already pregnant will use the drug, unwittingly giving themselves an abortion.
"Women have a right to know this drug is destroying a life growing in their womb," said Jeanne Monahan, director of the Family Research Council's Center for Human Dignity.
First Published June 12, 2010 12:00 am