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Food and Drug Administration: Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual
In April 2003, Women’s Capital Corp. submitted an

Our Price: $20.00
By Marcia Crosse (au)
Year: 2005
Pages: 57
Binding Paperback

Product Code: 1422304434

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-approvable” 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. and 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; and (3) whether there are age-related marketing restrictions for prescription Plan B and other prescription and OTC contraceptives. Illus.

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