THE FDA AND PLAN B: The Legislative History of the Durham-Humphrey Amendments and the Consideration of Social Harms in the Rx-OTC Switch

Abstract

The 1951 Durham-Humphrey Amendments limited the FDA’s power over the Rx-OTC decision by enacting an objective definition of a prescription drug that would be applied primarily by drug manufacturers. Under this regime, Congress likely intended the Rx-OTC decision to be limited to consideration of medical or scientific harms so as to insure the most limited role for the FDA, maximize the ability of the public to self-medicate, and insure consistency in different manufacturer’s Rx-OTC determinations. However, the 1962 Drug Amendments expanded the FDA’s power regarding Rx to OTC switches by requiring the FDA to balance the costs and benefits of a drug to determine whether it was in the best interest of society for the drug to be marketed OTC. Thus, social harms are appropriate considerations for the Rx-OTC decision if they are true societal costs of a drug, specifically, if they are quantifiable, generally accepted, and a reasonable probability. Applying these lessons to the proposed Rx to OTC switch of the emergency contraceptive Plan B, the FDA seems to have exceeded its authority by considering social harms—increased teen promiscuity and decreased teen condom use—that are not reasonably probable. Moreover, by failing to acknowledge that it was considering social harms the FDA threatened the transparency necessary to administrative accountability.