Dual marketing for Plan B

OB/GYN News, August 15, 2004 by Mary Ellen Schneider

Barr Pharmaceuticals Inc. is proposing to make levonorgestrel (Plan B) emergency contraception available over the counter for women aged 16 and older but to keep it as a prescription-only product for women aged 15 and younger. Barr made its proposal to the Food and Drug Administration in its formal response to the agency's "not approvable" letter.

The FDA rejected the company's bid for over-the-counter status in May despite a 23-4 vote in favor of the switch by an FDA advisory committee. In its decision, the FDA cited a lack of evidence surrounding the effects of OTC availability on women 16 and younger. "We are also working to increase awareness among women and health care providers as to the availability of [the] Plan B product and continue to work to increase the number of states where Plan B is available in pharmacies without an advance prescription." Dr. Carole Ben-Maimon, president and chief operating officer of Barr Research, said in a statement.