Over-the-Counter Sales of Plan B Approved
But the FDA still requires women under 18 to get a prescription for the emergency contraceptive
FRIDAY, Aug. 25 (HealthDay News) -- The U.S. Food and Drug Administration announced on Aug. 24 that it has approved over-the-counter sales of the emergency contraceptive Plan B, also known as the "morning-after pill," to women ages 18 and older. But Plan B will continue to be a prescription-only product for women ages 17 and under.
The approval requires Plan B's manufacturer, Duramed Research, Inc., of Bala Cynwyd, Penn., a subsidiary of Barr Pharmaceuticals, to comply with rigorous labeling, packaging, education, distribution and monitoring conditions under the CARE (Convenient Access, Responsible Education) program.
Under the program, Duramed agrees to restrict distribution of Plan B only to licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed health care practitioners and ensure that the drug is not available at convenience stores or other retail outlets where women under 17 could circumvent the prescription requirement. Duramed must also monitor the effectiveness of the distribution restrictions on Plan B.
"Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to over-the-counter use," according to the FDA statement. "Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package."