The Center for Reproductive Rights is on a "fishing expedition" for White House documents and testimony in a case related to FDA's rejection in 2004 of Barr Laboratories' application for nonprescription sales of the emergency contraceptive Plan B, and it should be denied the right to review such files, Department of Justice attorney John Tyler wrote in a letter sent to CRR on Thursday, the AP/Forbes reports (AP/Forbes, 11/30). CRR on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others filed a lawsuit claiming FDA did not follow procedure when the agency in 2004 sent a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B. Women's Capital later was purchased by Barr. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. 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. Barr in August resubmitted its application and FDA approved it later that month. CRR attorneys during two hearings in October at a U.S. District Court in New York City asked federal judges to grant a subpoena of White House documents related to the case. Federal Magistrate Viktor Pohorelsky last month ruled that CRR can seek more than three years of White House documents (Kaiser Daily Women's Health Policy Report, 11/10). A judge in the case on Nov. 21 issued a stay in the case that allows FDA to withhold certain documents from the group.

Letter
Tyler in the letter wrote it is "inappropriate" that CRR pursue the White House records while the stay is in place. CRR spokesperson Dionne Scott said the group plans to proceed with the lawsuit and require the White House to provide the relevant documents. She said the stay does not apply to the White House subpoena, adding that the group plans to continue to pursue the lawsuit and ask for the documents. Tyler also wrote that CRR has not met the "heightened standard" required for the White House to release documents, adding "the subpoena is a fishing expedition to probe the internal processes of the White House" (AP/Forbes, 11/30).