FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
On August 24, 2006, the U.S. Food and Drug Administration (FDA) announced approval of Plan B, a contraceptive drug often called the “morning after pill”, as an over-the-counter (OTC) option for women aged 18 and older. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. It will remain available as a prescription-only product for women aged 17 and under. Plan B is manufactured by Duramed Pharmaceuticals Inc., a subsidiary of Barr Pharmaceuticals, Inc., headquartered in Pomona, New York.
The FDA Release notes that the approval concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees. The process also provided an opportunity for public comment on issues regarding the scientific and policy questions associated with the new status of Plan B as an OTC medication. 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. With this in mind, the FDA has further noted that it remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.
For additional information about Plan B, please see WebMD.