FDA approves ella as 5-day-after emergency contraceptive
By Rob Stein
Saturday, August 14, 2010The 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.
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.
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