BUSH SIGNALS SUPPORT FOR BARR'S NEW PLAN B APPLICATION
The controversial approval process for OTC sales of Barr Pharmaceuticals' Plan B contraceptive may be coming to an end, as the nation's commander-in-chief has indicated new conditions added to the application meet his approval.
Barr resubmitted its application to the FDA Aug. 17, just over a week after the company and the FDA met to discuss conditions under which the agency would approve OTC use. Those conditions include changing the minimum age for OTC use from 16 to 18 and ensuring that the drug will be kept behind the counter at pharmacies and dispensed only with production of a valid photo identification establishing the age of the consumer. The amended application, according to FDA spokeswoman Susan Bro, addresses all of the recommended changes.
President Bush appears to back approval of the new application. Asked at an Aug. 21 press conference what he thought of Plan B in light of opposition from anti-abortion groups, he said it "ought to require a prescription for minors" and that he supports acting FDA Commissioner Andrew von Eschenbach's decision on the matter.
Barr first sought OTC status for Plan B in 2003, but the FDA rejected the request, saying the application lacked scientific data on the product's OTC use among adolescents younger than 16. The agency later postponed another Plan B review in August 2005.
The delay came under fire from abortion rights groups amid accusations that the White House had interfered with the FDA's decisionmaking process and that the agency was making its decision based on politics, not science. Earlier this month, the Center for Reproductive Rights, which has filed a lawsuit seeking to force a decision on the contraceptive, asked a federal court to allow it to subpoena all White House communications with the FDA over Plan B.