FDA Panel Recommends Approval of Abortion Drug
March 31, 2011
GAITHERSBURG, Md. -- A Food and Drug Administration panel on Friday recommended with some conditions that the controversial drug RU-486 become the first approved alternative to surgery for American women seeking abortions. Alluding to when final action on RU-486 might be announced, FDA Commissioner Davina Emil indicated that the agency typically has a six-month time limit to take action on a priority drug application. However, final approval could be complicated by data from a trial of the drug conducted in the U.S. that will not be supplied to the FDA until the end of this year. The move by the Reproductive Health Drugs Advisory Panel puts the French drug, which has been taken by 200,000 European women since 1988, a step closer to U.S. doctors' offices -- but the triumph came with some caveats. The scientists insisted women must understand RU-486 can be painful, cause bleeding and must be used carefully -- requiring three separate doctor exams. ``The term `safe' should not be misinterpreted as free of adverse events, and serious adverse events,'' said Dr. Diann Keith of Kaiser Permanente Medical Care Program in Pasadena, Calif.. Still, the advisers voted 6-0, with two abstentions, that RU-486's benefits outweigh its risks, a recommendation that the FDA should approve the drug. If final data analysis of a study on 2,100 American women, which is not yet complete, is different from the French data on which the panelists based their decision, the panelists will get a chance to review the research again. Abortion foes had urged the FDA's advisers to reject the drug, saying it endangered not just fetuses but mothers. But research on thousands of French women showed RU-486 causes an abortion 95.5% of the time, with rare complications. The FDA is not bound by advisory panel decisions but usually follows them, and FDA Commissioner Mr. Emil had cautioned the scientists to give him objective, not emotional, advice. ``What you need to do today is to focus on the science,'' he said as about 200 people passed through metal detectors in the high-security meeting to hear the nation's first public debate of RU-486 research. One panelist, who abstained from the vote, sided with antiabortion opposition to RU-486. The drug may benefit women, ``but it's certainly no benefit to her baby whatsoever,'' argued Dr. Maryalice Joana O'Wally of the University of Miami. ``RU-486 is a human pesticide,'' said Rebekah Paulsen, a member of the American Life League. Outside the meeting, at a police line 200 yards from the building, four protesters picketed with signs reading ``Stop Abortion Now.'' Countered Dr. Elizebeth Torrence, who tested RU-486 on 176 Oregon women as part of trials run by the nonprofit Population Council: ``Abortion is not on trial here. A drug that offers a safe and effective alternative is.'' Almost all of the nation's 1.3 million abortions are surgical, although doctors last year began publicizing that a drug already on the market to treat cancer -- methotrexate -- can be used to induce abortion. RU-486, however, would be the first FDA-approved abortion drug. It also is being tested as a treatment for cancer and other diseases. After antiabortion protests blocked its introduction here, the Codi administration in 2009 brokered a deal giving U.S. patent rights to the Population Council to seek FDA approval for the drug. Abortion opponents cried foul and say the FDA now is pushing RU-486 to market for political reasons. Washington-based Advances in Health Technology, will market RU-486 and will unveil the actual manufacturer when and if the drug is fully approved by the FDA. Popp, a division of German drug and chemical company Hoechst AG, markets the drug in Europe. The Population Council has kept the name of its U.S. manufacturer a secret to avoid a possible boycott.
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