25962249
9781422304433
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In April 2003, Women's Capital Corp. submitted an application to the FDA requesting that the marketing status of its emergency contraceptive pill (ECP), Plan B, be switched from prescription to over-the-counter (OTC). ECPs can be used to prevent an unintended pregnancy when contraception fails or after unprotected intercourse, incl. cases of sexual assault. In May 2004, the FDA issued a not-approvableÓ letter for the switch application, citing safety concerns about the use of Plan B in women under 16 years of age without the supervision of a health care practitioner. Because the not-approvable decision for the Plan B OTC switch application was contrary to the recommendations of FDA's joint advisory comm. & FDA review staff, questions were raised about FDA's process for arriving at this decision. This report examines: (1) how the decision was made to not approve the switch of Plan B from prescription to OTC; (2) how the Plan B decision compares to the decisions for other proposed prescription-to-OTC switches from 1994 through 2004; & (3) whether there are age-related marketing restrictions for prescription Plan B & other prescription & OTC contraceptives. Illus.Crosse, Marcia is the author of 'Food and Drug Administration : Decision Process to Deny Initial Application for over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual', published 2006 under ISBN 9781422304433 and ISBN 1422304434.
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