Critics blast pill certified by FDAWASHINGTON
The Food and Drug Administration yesterday 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 is 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 both said that the decision marks the clearest evidence of a shift in the influence of political ideology at the FDA.
The last time that the FDA considered an emergency contraceptive -- making Plan B available without a prescription -- the decision became mired in controversy because of similar concerns from anti-abortion activists. Plan B was eventually approved for sale to women 18 and older without a prescription, but only after repeated delays.
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, the 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 that the decision reflects 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, the director of 40 Days for Life, a Fredericksburg, Va.-based anti-abortion group.
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 the abortion pill 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 if the drug would cause an abortion because it has never been tested for that.
Critics, however, are convinced that it will, and fear that women who do not realize that they are pregnant will use the drug, unwittingly giving themselves an abortion. They also worry that men will slip ella to unsuspecting women. Some women might knowingly use ella to try to abort a fetus, putting themselves at risk for potentially serious complications that have been reported among a small number of women using RU-486 and possibly damaging their developing child if it doesn't work, the critics say.
On Aug. 2, such concerns prompted 91 members of Congress to send a letter to FDA Commissioner Margaret Hamburg, urging her not to approve ella.
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 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 yesterday to start a campaign publicizing ella's possible abortion powers, including posting a YouTube video.
"Ella is an abortion drug," said Wendy Wright, the 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 after 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 that ella is safe, causing only minor side effects, such as headaches, nausea, abdominal pain and dizziness, the company said.
Ella is 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.
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.
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