FDAnews Drug Daily Bulletin


June 14, 2006

The FDA has come out swinging in the latest development over whether the agency should approve the controversial Plan B contraceptive for OTC use.

The FDA used a recent letter rejecting the Center for Reproductive Rights' (CRR) petition asking the agency to approve Plan B for OTC use to argue that CRR lacks the standing to continue its Plan B lawsuit. The group is suing the agency to force the FDA to approve OTC status for Barr Pharmaceuticals' contraceptive.

The agency faces increasing pressure from lawmakers such as Sen. Edward Kennedy (D-Mass.), the ranking member of the Senate Health, Education, Labor and Pensions Committee, to make a decision on the Barr application. Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) had earlier held up Andrew von Eschenbach, President Bush's nominee to be the FDA commissioner, because of the Plan B controversy.

The CRR suit has made public details of the agency's decisionmaking process through a series of depositions of current and former high-ranking FDA officials. These depositions have revealed that former Commissioner Lester Crawford took the Plan B review out of career staffers' hands.

But the group lacks the standing or the authority to force the FDA to make a decision on Barr's application, the agency said. CRR can't act on Barr's behalf because "you lack any commercial, financial, associational, fiduciary or confidential relationship with Barr and therefore you cannot represent its interests," the letter added. The agency maintains that CRR's efforts to expedite the OTC review would deny Barr its statutorily granted right to a full drug application review. Moreover, even if the group had standing, it lacked the data to back up its claims, the agency said. (http://www.fdanews.com/did/5_115/)