Prescription Requirements and Patient Autonomy: Considering an Over-the-Counter Default
Madison Kilbride, Steven Joffe, and Holly Fernandez Lynch

When new drugs are approved by the Food and Drug Administration, the default assumption is that they will be available by prescription only, safe for use exclusively under clinical supervision. The paternalism underlying this default must be interrogated in order to ensure appropriate respect for patient autonomy. Upon closer inspection, prescription requirements are justified when nonprescription status would risk harm to third parties and when a large segment of the population would struggle to exercise their autonomy in using a drug safely and effectively on their own. Although these justifications can support prescription status for many drugs, this article proposes that reversing the FDA's current default to instead begin with a presumption in favor of over?the?counter status is the best way to avoid interference with valid claims of patient autonomy. Under this approach, a range of drug products, including oral contraceptives, statins, and HIV?prevention drugs, could be considered for an OTC switch. The authors are at the Perelman School of Medicine at the University of Pennsylvania.

Also in this issue:

The Social Risks of Science
Jonathan Herington, Scott Tanona

Another Voice: Health Research and Social Justice Philosophy
Sridhar Venkatapuram

Case Study: A Small-Town Heart
Tim Lahey, Jennifer L. Herbst, Marielle S. Gross, Brandi Braud Scully

Perspective: OK, Boomer, MD: The Rights of Aging Physicians and the Health of Our Communities
Tia Powell

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The table of contents of the November-December 2020 Hastings Center Report is available here: Hastings Center Report: vol. 50, no. 6 (wiley.com).

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