U.S. Pharmacist

Advertisement
Advertisement

FDA’s Advice to Sell Plan B One-Step OTC Overruled

By Staff


1/20/2012

US Pharm. 2012;37(1):10.

Silver Spring, MD—The FDA’s recommendation that the age restriction on the emergency contraception pill Plan B One-Step be eliminated to allow it to be sold without a prescription to adolescents younger than 17 years was overruled by Health and Human Services Secretary Kathleen Sebelius. According to Sebelius, medical evidence from actual-use studies was insufficient to support the manufacturer’s (Teva Pharmaceuticals) application to make the drug available OTC to all girls of reproductive age. The FDA, however, maintained that the safety and efficacy of the drug for all females of childbearing potential were well supported by data from the two trials conducted by Teva. The drug remains available OTC to adolescents aged 17 and older.

To comment on this article, contact rdavidson@uspharmacist.com. 
Advertisement

U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Copyright © 2000 - 2014 Jobson Medical Information LLC unless otherwise noted.
All rights reserved. Reproduction in whole or in part without permission is prohibited.