Plan B OTC access extended to 17-year-olds
The Food and Drug Administration (FDA) is complying with a federal judge's instruction and is directing the manufacturers of the dedicated emergency contraceptive pill Plan B to make the drug available to 17-year-olds without prescription
According to a April 2009 statement issued by the federal agency, it has notified the drug's manufacturer, Duramed Research, that it may market the drug without a prescription to women 17 years of age and older upon submission and approval of an appropriate application.
The U.S. District Court for the Eastern District of New York ordered the FDA in March 2009 to make Plan B available over the counter (OTC) to women ages 17 and older. The ruling was spurred by a lawsuit filed in 2005 by the Center for Reproductive Rights on behalf of the Association of Reproductive Health Professionals and several other women's health organizations.
Plan B has been distributed since 2006 under a dual-label status that allowed it to be sold "behind the counter," but without a prescription, to women 18 years of age and older, with prescription-only availability for females 17 and younger.
The Food and Drug Administration (FDA) is complying with a federal judge's instruction and is directing the manufacturers of the dedicated emergency contraceptive pill Plan B to make the drug available to 17-year-olds without prescription.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content