Drug Regulation When Patients Can’t Wait

Thursday, September 12, 2024

For most of the 20th century, the Food and Drug Administration (FDA) made progress toward ensuring patients could have confidence that their medicines were both safe and effective. But there is often tension between speedy access and certainty about the benefit of new drugs.

Beginning with the HIV patient advocacy movement, the FDA has increasingly emphasized flexibility, prioritizing access for patients facing serious diseases with no time to wait. This lecture will discuss the current challenges confronting the FDA as it seeks to address the needs of current and future patients.

About the Speaker

Holly Fernandez Lynch is an associate professor of medical ethics and law at the University of Pennsylvania. Trained as a bioethicist and lawyer, she pursues conceptual and empirical scholarship regarding clinical research ethics and regulation, access to investigational medicines, and FDA pharmaceutical policy, especially approaches to drug development and early approval pathways for diseases with unmet treatment needs. From 2023 to 2024 she served as a member of the National Academies ad-hoc committee “Amyotrophic Lateral Sclerosis: Accelerating Treatments and Improving Quality of Life.” She is an elected fellow of the Hastings Center and a National Academy of Medicine Emerging Leader in Health and Medicine.

About the Series

The Joseph Priestley Society (JPS) promotes a deeper understanding of science, technology, and industry, with an emphasis on innovation and entrepreneurship. Speakers are leaders from a wide variety of large and small chemical companies and the financial, consulting, and academic communities. View past JPS events at sciencehistory.org/jpsvideos.

For more information about this event, please contact jps@sciencehistory.or g.

Featured image: Certified Pharmacal Company aspirin pillbox, 1910–1950.