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Carmel Shachar, Recent Developments in Health Law Administrative Law v. Constitutional Law: The Correct Decision on FDA's Treatment of Plan B, 37 J. L. Med. & Ethics 523 (2009).

Abstract: In order for the Food and Drug Administration (FDA) to receive the trust and deference it needs to accomplish its mission, it must be seen as relatively impervious to political manipulation. For most of the FDA’s history, it has been seen as an institution driven by scientific expertise, not by political maneuvering. However, the FDA was increasingly criticized during the Bush administration for politicizing decisions such as rejecting an application to grant the “morning after pill,” known as Plan B, over-the-counter (OTC) status for women of all ages. After an atypical approval process, the FDA approved OTC Plan B use only for women over the age of 18. Because some groups perceive the morning after pill as a form of abortion, the politically appointed leadership of the FDA was suspected of dramatically departing from normal FDA procedures in order to ensure that the application would not be approved.