21st Century Citizen Pharma: The FDA & Patient-Focused Product Development

Abstract

Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration (FDA). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA’s activity in drug, biologic, and medical device regulation over the course of the last one-hundred plus years. The most recent fundamental reframing of the agency’s authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process. This Article explores recent developments in patient-focused product development efforts at the FDA and offers modest insights on the increasing role of patients, and patient advocacy groups, in agency decision-making. The Article terms this era “21st century citizen pharma.”

Keywords: Patient Advocacy, 21st Century Cures Act, FDA, Drugs, Devices, Biologics