BARR FORMS POSSIBLE AGREEMENT WITH FDA ON PLAN B
Barr Pharmaceuticals is making a change to its Plan B application that should clear the way for the FDA to approve the contraceptive for OTC use, a Barr spokeswoman said.
Representatives from Barr's subsidiary, Duramed Pharmaceuticals, and the agency met Aug. 8 to discuss the FDA's recent framework to approve the drug for OTC use. The meeting was "very productive, very positive," and has led the company to make an amendment to its application that may meet the agency's requirements and answer the questions necessary to sell Plan B (levonorgestrel) OTC, Carol Cox, Barr's vice president for investor relations and corporate communications, said. But Cox declined to explain what the amendment involves.
The FDA confirmed that the company agreed to amend its application, but also declined to elaborate. "We look forward to receiving it and moving forward with our review," an FDA spokeswoman said.
However, when the agency announced its framework July 31, one of the prerequisites was that Duramed amend its application for Plan B to change the minimum age for OTC use to 18. The company had originally requested that women 16 years and older be able to obtain the drug OTC. The agency also required a variety of enforcement efforts from Duramed, including assurances 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 customer.
Many lawmakers and activists see the Plan B issue as a symbol of an agency making decisions based on politics rather than science. As a result, Sens. Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-N.Y.) are pledging to hold up the administration's nomination of Andrew von Eschenbach to be FDA commissioner. The agency is also facing a lawsuit from the Center for Reproductive Rights.
The company will formally propose this amendment within two weeks, Cox said. Duramed has scheduled no other meetings with the FDA.