FDA Approves New Emergency Contraceptive

On Friday, FDA approved the emergency contraceptive ulipristal acetate for preventing pregnancy for up to five days after sex, the New York Times reports. The agency approved the pill, which will be sold under the brand name ella, for prescription-only use. Ella is manufactured by the French-based HRA Pharma and will be distributed in the U.S. by Watson Pharmaceuticals, which said it will introduce it by the end of 2010 (Harris, New York Times, 8/13). Watson has not announced a price for ella (Reuters/Los Angeles Times, 8/14).

Studies have shown that ella is more effective for a longer period of time than Teva Pharmaceuticals' Plan B, an EC pill that is available without prescription to women ages 17 and older. Plan B can be taken up to three days after sex but gradually loses its effectiveness, unlike ella, which maintains its efficacy for up to five days. Regulators say that women who have unprotected sex have a one in 20 chance of becoming pregnant. Women who take Plan B within three days reduce that risk to about one in 40, and women who take ella within five days would reduce that risk to about one in 50 (New York Times, 8/13). According to Watson, the overall pregnancy rate for women who took ella within three days of sex was 1.9%, and the pregnancy rate was 2.2% for women who took the drug within five days (Reuters/Los Angeles Times, 8/14).

The decision to approve ella comes less than two months after an FDA advisory committee determined that it is safe and effective and unanimously recommended its approval. According to the Times, chemicals in ella block the effects of progesterone, a hormone that spurs ovulation. There is also "some evidence" that the pill can reduce the lining of the uterus, which makes it difficult for a fertilized egg to further develop, the Times reports.

Antiabortion Groups Voice Concerns

Antiabortion-rights that opposed the approval said that preventing implantation of a fertilized egg is the equivalent of an abortion (New York Times, 8/13). Based on this reasoning, Rep. Christopher Smith (R-N.J.) said that FDA was "misclassifying" ella as a contraceptive. Smith added that he plans to call on President Obama to issue an executive order prohibiting federal funds from paying for ella. Several antiabortion groups, including the Family Research Council, on Friday said they would launch a campaign publicizing their argument against ella.

Antiabortion critics also are concerned that ella will be eligible for federal tax subsidies and be included in the services health insurance providers will be required to cover under the federal health reform law (PL 111-148). Ella also is likely to intensify the debate over whether physicians and pharmacists have the right to refuse to provide prescriptions for medications they oppose on moral or religious grounds.














Decision Marks Shift at FDA

Advocates say that ella's approval is the "clearest evidence of a shift in the influence of political ideology at FDA," the Washington Post reports. FDA's decision to make Plan B available without a prescription to women ages 17 and older was "mired in controversy," as the decision was delayed repeatedly by political advisers in the George W. Bush administration. Kirsten Moore, president of the Reproductive Health Technologies Project, said, "Women's health advocates appreciate that the review process for ella was consistent with standard FDA procedure and based on scientific evidence, not politics." She added, "Approval of ella is further evidence that the FDA is committed to restoring scientific integrity in its decisions" (Stein, Washington Post, 8/14).


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