Advisory panel recommends FDA approve new "morning after" pill

The New York Times: A Food and Drug Administration advisory panel Thursday recommended that the agency approve "a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex. The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex. Ella, by contrast, works just as well on the fifth day as the first after sex. Ella blocks the effects of progesterone, a female hormone that spurs ovulation. It is a chemical relative to RU-486, the abortion pill, and some mystery remains over exactly how it works. That mystery spurred a fierce debate outside the committee over whether it should be considered an abortion drug, a debate that prompted the posting of several uniformed police officers around the meeting room." The FDA often, but not always, follows the advice of its advisory panels (Harris, 6/17).

Agence France-Presse: "A US health panel Thursday voted unanimously to allow the sale of a controversial French birth control pill. … The move is likely to stir controversy from the anti-abortion movement, because of the way it works. The manufacturers, France's HRA Pharma laboratory, say it delays ovulation, while opponents maintain it works by stopping a fertilized egg from implanting in the walls of a woman's uterus. … HRA said it hopes to market Ella in the United States by the end of the year through its US partner Watson Pharmaceuticals." It would be sold by prescription in the U.S., just as it is in Europe (6/17).

USA Today: "The panel called the effectiveness data, which were based on research involving more than 4,000 women in the USA and Europe, 'compelling.' Because ella hasn't yet been approved, Mayr said, he couldn't say how much it would cost. The European Commission approved ulipristal in May 2009. HRA Pharma, a French firm that has entered into an exclusive licensing agreement with Watson in the USA, launched the drug in October 2009. It is marketed under the brand name ellaOne in 22 European countries (Rubin, 6/18). 

The Associated Press/CBS News: "In a head-to-head trial between the two drugs, women who took ellaOne had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. … Experts tracked nearly 1,700 women who received emergency contraception within three to five days of having unprotected sex. … The FDA is scheduled to make a decision on ellaOne by late July" (6/17).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.