WASHINGTON — The Food and Drug Administration on Friday approved a controversial new form of emergency contraception that can prevent a pregnancy for 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. Critics, however, condemned the decision, arguing that it was misleading to approve ella as a contraceptive because the drug could also be used to cause abortions.
Ella can reduce the chances of becoming pregnant after unprotected sex by about two-thirds for at least 120 hours, 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, begins to lose its effectiveness almost immediately and becomes ineffective after 72 hours.
Supporters and opponents 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 became mired in controversy because of similar concerns by anti-abortion activists. Plan B was eventually approved for sale to women 18 and older without a prescription, but only after repeated delays.
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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 a month ago. Women will need a prescription for ella 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."
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 40 Days for Life, a Fredericksburg, Va.-based anti-abortion group.
May receive subsidies
Critics are also concerned that ella's approval as a contraceptive will make it eligible to receive subsidies using federal tax dollars, which is banned for the abortion pill RU-486, and include it in the list of services that health plans will have to pay for under the new health reform law. The Family Research Council and several other groups announced plans Friday to launch a campaign publicizing ella's possible abortion powers, including posting a YouTube video.
"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. The company has no plans to test ella as an abortion drug, but it did not appear to cause any problems for the handful of women who became pregnant despite taking the drug, according to officials at HRA Pharma of Paris, which makes the drug. 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 company said.
Watson Pharmaceuticals of Corona, Calif., 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.