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Barr Laboratories on Tuesday said that it will resubmit its application for nonprescription sales of its emergency contraceptive Plan B and that once FDA receives the application the agency will act quickly on a decision, the New York Times reports (Harris, New York Times, 8/9). FDA in May 2004 issued a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B, which can prevent pregnancy if taken up to 72 hours after sexual intercourse. Barr purchased Women's Capital during consideration of the application. FDA in the "not approvable" letter cited inadequate data on its use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available only to girls and women ages 16 and older. Former FDA Commissioner Lester Crawford in August 2005 opened a 60-day public comment period on the application, saying that science supported approval of nonprescription Plan B access for women and girls ages 17 and older but that the application presented FDA "with many difficult and novel policy and regulatory issues," including how to enforce an age restriction. In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. The letter also requested that Barr meet with FDA within seven days, make unspecified changes to the packaging for Plan B and provide a thorough description of the company's plan to enforce the age restriction. The letter says, "If after our discussions we conclude (your) program isn't sufficiently rigorous, ... Plan B will remain [prescription]-only for women of all ages (Kaiser Daily Women's Health Policy Report, 8/3). The company and FDA officials on Tuesday met in Washington, D.C., to discuss the application (AP/St. Paul Pioneer Press, 8/9). FDA spokesperson Susan Bro and Barr spokesperson Carol Cox called the meeting between FDA and Barr "productive" (Reuters, 8/8). Barr after the meeting announced it planned to amend the Plan B application within two weeks, and Cox said FDA "made it clear to us they intend to act quickly" on the application (AP/St. Paul Pioneer Press, 8/9). When asked about the new age restriction requirement, Cox said, "These are all issues we can work through." FDA officials did not comment (Howard Price, Washington Times, 8/9). In related news, Barr CEO Bruce Downey said that von Eschenbach in a call said the agency was determined to resolve the Plan B debate (New York Times, 8/9). Sen. Rodham Clinton Praises Acting FDA Commissioner Von Eschenbach, Pledges To Continue Hold on Confirmation In related news, Sen. Hillary Rodham Clinton (D-N.Y.) on Monday during a press conference at a Harlem health clinic praised von Eschenbach, but vowed to continue to block his confirmation, the New York Daily News reports (Lite, New York Daily News, 8/8). Rodham Clinton and Sen. Patty Murray (D-Wash.) plan to block von Eschenbach's confirmation until FDA announces whether it will approve or reject nonprescription sales Plan B (Kaiser Daily Women's Health Policy Report, 8/7). Von Eschenbach is a "qualified, experienced physician," but "[h]e is trying to serve both masters: the administration that nominated him [and] the Senate, which has to confirm him," Rodham Clinton said. She added, "But the proof is in the pudding, and I am not lifting my hold until we get a decision." An FDA spokesperson was not available for comment (New York Daily News, 8/8). Election-Related News Virginia senatorial candidate James Webb (D) and the Family Foundation in Richmond, Va., criticized Sen. George Allen's (R-Va.) ownership of Barr stock, the Washington Post reports. Allen, who opposes abortion except in cases of rape or incest or to save the life of a woman, in January 2004 purchased the stock, which is valued at $1,000 to $15,000, the Post reports. Webb, who supports access to the procedure and opposes late-term abortion, in a statement said that his campaign is "troubled" that "Allen is profiting off a drug that many of his evangelical supporters consider a form of abortion." Webb added, "It seems hypocritical to oppose a woman's right to choose while investing in a drug that does just that." Chris Freund, policy director for the Family Foundation, said, "Given [Allen's] pro-life record, I think pro-life Virginians would be very confused by this decision to invest in the only producer of the morning-after pill," adding, "I think the issue of the morning-after pill really goes to the heart of the abortion debate, and for a lot of pro-life Virginians, this is the issue of the day." Allen on Tuesday said in an interview that he has no plans to sell his stock, adding that stock purchases should not be an issue in the campaign and that voters should focus on his record. "Look at the way I vote," Allen, who according to the Post often receives perfect ratings from the National Right to Life Committee, said, adding that he owns the stock because Barr operates a plant in Virginia and is important to the state's economy. Allen added that Barr is a "good company that works hard in the community" (Craig, Washington Post, 8/9). You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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