Issue of Emergency Contraception Raised at House Hearing
Acting FDA Commissioner Andrew Von Eschenbach when questioned by members of a House subcommittee on Thursday reaffirmed that science, not politics, would play a role in the decision to approve Barr Laboratories' application for nonprescription sales of its emergency contraceptive Plan B, adding that the agency would carry out the process in the "appropriate fashion," the AP/San Jose Mercury News reports (Freking, AP/San Jose Mercury News, 2/16).
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 (California Healthline, 11/15/05).
Former FDA Commissioner Lester Crawford in August 2005 announced that the agency would indefinitely defer the application and opened a 60-day public comment period on it, which expired on Nov. 1, 2005 (California Healthline, 11/2/05).
While appearing before the House Agriculture Appropriations Subcommittee to discuss FDA's fiscal year 2007 budget proposal, Von Eschenbach credited the potential "enormous complexity" of about 10,000 comments submitted to the agency during the comment period for the delay in deciding on Barr's application. He told the subcommittee, "[T]here are obviously a large number of them, and they are complex" (CQ HealthBeat, 2/16).
According to the AP/San Jose Mercury News, Democrats on the subcommittee questioned Von Eschenbach on the application, citing politics as the main reason for the agency's delay. Von Eschenbach denied that politics are playing a role in the decision, and he added that he could not provide a timetable for FDA's decision (AP/San Jose Mercury News, 2/16).