[Jan 03, 2006]
A lawsuit attempting to force the government to allow nonprescription sales of Barr Laboratories' emergency contraceptive Plan B can continue, federal Judge Edward Korman said on Dec. 22, 2005, Long Island Newsday reports (Kerr, Long Island Newsday, 12/23/05). FDA in May 2004 issued a "not approvable" letter in response to Barr's original application to authorize nonprescription sales of Plan B, citing inadequate data on its use among girls under age 16. After FDA rejected Barr's first application, the company submitted a revised application to make nonprescription Plan B available only to women ages 17 and older (Kaiser Daily Women's Health Policy Report, 12/05/05). In January 2005, FDA announced a delay in its decision on the revised application, after which the Center for Reproductive Rights -- on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others -- filed a lawsuit against FDA in a U.S. District Court in New York, claiming that the agency did not follow its procedures when it first denied the application (Kaiser Daily Women's Health Policy Report, 1/24/05). The lawsuit also says that by not approving nonprescription sales, FDA violated women's right to equal protection and privacy as guaranteed by the U.S. Constitution, according to Newsday. Assistant U.S. Attorney Franklin Amanat said that CRR does not have the legal standing to file the suit. However, Korman disagreed with Amanat, saying, "There's a serious issue here as to whether [FDA is] acting in good faith" (Long Island Newsday, 12/23/05).
For current women's health policy news, visit the National Partnership for Women & Families' website.