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Court Documents Reveal FDA Politicized Plan B Approval

August 24, 2006

Recently released court documents in a suit filed against the Food and Drug Administration charge that the FDA faced undue political pressure by the Bush Administration to stymie over the counter sales of the Plan B morning after pill. The documents were released as part of a lawsuit filed in January 2005 by the Center for Reproductive Rights against the FDA. Depositions were taken of FDA officials in the lawsuit. At the center of the controversy is a request by Barr Pharmaceuticals to sell its emergency contraceptive, Plan B, without a doctor’s prescription. In recent weeks, the Washington rumor mill has been in over drive over an imminent decision by the Food and Drug Administration (FDA) to let Plan B emergency contraception be sold over the counter. Even President Bush made his first direct public statement this week on Plan B, which has delayed a Senate confirmation vote on his nominee to head the FDA, acting commissioner Andrew von Eschenbach. Bush skipped his ususal stock answer about “promoting the culture of life,” and indicated he supports the over-the-counter sale of Plan B, except for minors. “I believe Plan B ought to be a required prescription for minors,” Bush said, adding he supports “Andy’s decision.” The acting FDA commissioner, von Eschenbach, had testified at a U.S. Senate committee hearing last week that he thinks Plan B can be sold safely to women over the age of 18. Despite the seeming change of heart, the recent court documents support the widespread impression that the Bush administration has politicized this women’s health issue, in order to appease its base. Healthcare officials across the country have criticized the FDA for making decisions affecting women’s health that are based on politics and not science. When the FDA makes decisions based on politics and not science, public health suffers. For years, countless women who have been victims of rape or incest, or have had to contend with broken condoms or unprotected sex for any reason have faced obstacles in obtaining emergency contraception that would otherwise not have been there had this supposed independent federal agency not capitulated to the White House and its political agenda. The hoopla began on July 31 when the FDA announced that it would reopen discussion with Barr Pharmaceuticals regarding the approval of Plan B to be sold over the counter only to women 18 and older. Plan B, approved as a prescription in 1999, is a set of two high dose hormone pills that can prevent pregnancy if taken within 72  hours of sexual intercourse. The drug has come under fire from conservative groups, who have erroneously tagged it as an abortion pill (it instead blocks the release of an egg from an ovary). Barr Pharmaceuticals had failed in two attempts to win government approval to sell Plan B drug more widely without a prescription. Its first application in 2003 covered women of all ages, but was rejected. The second was limited to women 16 and older. The FDA then postponed a decision. However, the timing of the FDA’s recent announcement that it would reopen its discussions with Barr drew suspicion, as it came one day before the President’s presumptive nominee to head the FDA, von Eschenbach, was to testify at his Senate Committee confirmation hearing. Senator Patty Murray of Washington and Senator Hilary Clinton of New York have exercised a hold on von Eschenbach’s nomination until the FDA approves Plan B for over-the-counter use. While this news is somewhat welcoming--denying minors access and other potential restrictions aside--information has surfaced that the FDA’s rejection of Plan B’s move to over-the-counter staus in the spring of 2004 may have been the Bush Administration’s plan all along. The FDA’s rejection came despite overwhelming support by its own scientists, and the subsequent resurrection of Plan B for women 18 and older (a move which came after the 2004 election). Recently released depositions taken from senior FDA officials as part of a lawsuit filed by the Center for Reproductive Right’s (the Center), Tummino v. von Eschenbach indicate the politicization of the issue was more widespread than previously known. In the depositions taken earlier this year, Dr. John Jenkins, director of the FDA’s Office of New Drugs, testified that approval of Plan B was rejected in May 2004 by then-FDA Commissioner Mark McClellan—but the rejection occurred well before the FDA had completed its approval process of Plan B. Even more damning, Dr. Florence Houn, a senior FDA scientist who was involved in reviewing the appplication, testified she was instructed by Dr. Janet Woodcock, a former acting deputy commissioner, of the need to appease the “adminstration’s constituents” by nixing the over-the-counter status for women of all ages, but then approving it down the road with an age restriction. “She conveyed to me her assurance that this was the only way to go, to issue a non-approval letter to appease the administration's constituents, and then later this could be approved," Houn testified.However, Dr. Houn added in her deposition that she was unaware of any political pressure put on FDA officials. This discovery of the undue political influence by the White House in the Plan B decision and contradictory statements made by McClellan (now head of the Center for Medicare & Medicaid Services, a division of the U.S. Department of Health & Human Services) and the former FDA official, Woodcock, led the Center to request subpoenas for White House documents on any and all communications between the Bush Adminstration and McClellan, as well as other FDA officials. Not surprisingly, on August 11, the White House asked for a dismissal of the request, claiming the Center was demanding too many documents and asserted executive privilege. Regardless of the decision made by the FDA, the lawsuit will continue. According to an August 3rd statement released by the Center, the requirements announced just prior to von Eschenbach’s Senate hearing “still violate the constitutional rights of women in need of emergency contraception and would perpetuate the agency’s non-scientific reasons for denying over-the-counter access for younger women.”

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