Barr Laboratories on Thursday submitted an application to FDA to sell the emergency contraceptive Plan B over the counter for women age 16 and older, the AP/Las Vegas Sun reports (Neergaard, AP/Las Vegas Sun, 7/22). FDA in May decided to issue a "not approvable" letter to an application submitted by Barr to market Plan B -- which can prevent pregnancy if taken within 72 hours of unprotected sexual intercourse -- over the counter over concerns about inadequate clinical data on the use of the medication among girls younger than age 16. The decision contradicted the recommendations of two FDA advisory committees, which in December 2003 voted 23-4 to recommend OTC status for Plan B. In addition, Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said that he made the decision to reject the application on his own and did not follow the recommendations of his staff (Kaiser Daily Reproductive Health Report, 7/14). Barr said that its new proposal -- which allows women age 16 and older to buy Plan B over the counter and requires a prescription for younger women -- will "lead to approval," according to Reuters. An FDA spokesperson said that the agency would not comment (Reuters, 7/22). FDA has never approved a "mixed marketing" OTC approach requiring pharmacies to check customers' ages (AP/Las Vegas Sun, 7/22).

Reaction
Carol Cox, a spokesperson for Barr, said that FDA has "given us every indication they're willing to work with us on this proposal," adding that Barr will seek more safety data that could eventually lead to OTC status for Plan B for women of all ages, according to the Long Island Newsday (Kerr, Long Island Newsday, 7/23). Dr. Scott Spear, chair of the national medical committee of Planned Parenthood Federation of America, said that Barr's new proposal is a "response to the political realities created by the FDA," adding that FDA's call for an age requirement for OTC status for Plan B is "bogus," according to the Bergen Record. Spear added, "One could argue that younger women need (OTC availability) even more than older women who have more resources at hand." Kirsten Moore, president and CEO of the Reproductive Health Technologies Project said that FDA may "back out" of approving the mixed-marketing approach or that Barr could face a lawsuit challenging the age requirement because there is no legal precedent allowing it (Krauskopf, Bergen Record, 7/23). Carole Ben-Maimon, head of research for Barr, said that the company will "continue to work to increase the number of states where Plan B is available in pharmacies without an advance prescription" (Reuters, 7/22).