By Rob Stein
Saturday, August 14, 2010; A01
The Food and Drug Administration approved a controversial new form of emergency contraception Friday that can prevent a pregnancy as many as five days after sex.
The decision to allow the sale of the pill, which will be marketed under the brand name "ella," was welcomed by family-planning proponents as a crucial new option to prevent unwanted pregnancies. But critics condemned the decision, arguing that it was misleading to approve ella as a contraceptive because the drug could also be used to induce an abortion.
Ella can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown. The only other emergency contraceptive on the market, the so-called morning-after pill sold as Plan B, is significantly less effective, becomes less effectual with each passing day and will not work after 72 hours.
Supporters and opponents both said the decision marked the clearest evidence of a shift in the influence of political ideology at the FDA. The last time the FDA considered an emergency contraceptive -- making Plan B available without a prescription -- the decision was mired in controversy amid similar concerns voiced by antiabortion activists. After repeated delays, Plan B was approved for sale to women 17 and older without a prescription.
Ella, which was approved in Europe last year and is available in at least 22 countries, was unanimously endorsed by an FDA advisory committee less than two months ago. Women will need a prescription but could keep a supply at home.
"Women's health advocates appreciate that the review process for ella was consistent with standard FDA procedure and based on scientific evidence, not politics," said Kirsten Moore, president of the Reproductive Health Technologies Project. "Approval of ella is further evidence that the FDA is committed to restoring scientific integrity in its decisions."
For their part, critics said the decision reflected the abortion-rights stance of the Obama administration.
"They are choosing political ideology and the abortion industry's radical agenda over women's health and the safety of their children," said David Bereit, director of the Fredericksburg-based antiabortion group 40 Days for Life.
If the history of Plan B is any indication, ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug.
Critics are already concerned that ella's approval as a contraceptive will make it eligible to receive federal tax subsidies, which are banned for the abortion pill RU-486,. They also are concerned that ella will be included in the services that health plans will have to pay for under the new health-care overhaul law.
"By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion," said Rep. Christopher H. Smith (R-N.J.), who called on Obama to issue an executive order prohibiting federal funds from paying for ella.
Ella is also likely to exacerbate a long-running debate over whether doctors have an obligation to write prescriptions for medication they oppose on moral grounds and whether pharmacists have an obligation to fill them. Many doctors and pharmacists refuse to write or fill prescriptions for Plan B or refer patients elsewhere for it.
"I am certain that pharmacists will refuse to fill prescriptions for" ella, said Karen L. Brauer of the group Pharmacists for Life International.
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 abortion.
Ella, known generically as ulipristal acetate, works as a contraceptive by blocking progesterone's activity, delaying the ovaries from producing an egg. But progesterone is also needed to prepare the womb to accept a fertilized egg and to nurture a developing embryo. That's how RU-486 prevents a fertilized egg from implanting and dislodges growing embryos. Ella's chemical similarity to RU-486 raises the possibility that it might do the same thing, perhaps if taken at elevated doses. But no one knows for sure whether the drug would induce an abortion, because the drug has never been tested that way.
Critics, however, are convinced it will and fear that a woman who does not realize she is pregnant will use the drug, unwittingly giving herself an abortion. They also worry that men will slip ella to unsuspecting women. And, the critics say, a woman might knowingly use ella to try to abort a fetus, putting herself at risk for potentially serious complications that have been reported among a small number of women using RU-486 and possibly damaging her developing child if it doesn't work.
The Family Research Council and several other groups announced plans Friday to launch a campaign publicizing ella's possible abortion potential.
"Ella is an abortion drug," said Wendy Wright, president of Concerned Women for America. "It operates the same way as RU-486, the abortion drug. Many women may be comfortable taking a contraceptive but would object to taking an abortion drug."
Proponents dismiss the concerns, saying that ella has been tested only within five days of unprotected sex and there is no evidence that it works as anything other than a contraceptive. HRA Pharma of Paris, which makes ella, has no plans to test it as an abortion drug, but it did not appear to cause any problems for the handful of women who became pregnant after taking the drug, according to company officials. Studies involving more than 4,500 women in the United States show ella is safe, causing only minor side effects, such as headaches, nausea, abdominal pain and dizziness, the FDA said.
"Ella will become an important option for women," said Vanessa Cullins of the Planned Parenthood Federation of America.
Watson Pharmaceuticals, which will market the drug in the United States, hopes to make ella available by the end of the year. The price has not yet been announced.