U.S. FDA APPROVES OTC PLAN B FOR WOMEN 18 AND OVER

The FDA today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." The drug will remain available as a prescription-only product for women 17 and under.

Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. The company has agreed to: provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B; ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services and clinics with licensed healthcare practitioners; design packaging to hold both OTC and prescription Plan B; and monitor the effectiveness of the age restriction and the safe distribution of the drug.

Today's action concludes an extensive process that included obtaining advice from two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application for OTC Plan B.