Wednesday, March 2, 2022


Panel Discusses Hot Topics for the Food and Drug Administration

On March 1, the Solomon Center for Health Law and Policy, in collaboration with the Yale Health Law and Policy Society, hosted a panel discussion on hot topics for the Food and Drug Administration (FDA).

Dr. Joseph Ross, Professor of Medicine (General Medicine) and Public Health at the Yale School of Medicine, moderated the panel that included Visiting Professor of Law Dr. Aaron Kesselheim, a Professor of Medicine at Harvard Medical School; Dr. Joshua Sharfstein, Professor of the Practice in Health Policy and Management at Johns Hopkins Bloomberg School of Public Health; and Patricia Zettler, Associate Professor at Moritz College of Law and faculty member of the Drug Enforcement and Policy Center and the Comprehensive Cancer Center at The Ohio State University.

The panel of experts discussed several facets of the FDA’s role in health administration. The agency is taking on a larger role as a public health agency during the ongoing COVID-19 pandemic, according to the panelists.

The panel discussed opportunities for the FDA to exercise greater authority over tobacco products as well as the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). In addition, panelists addressed how the FDA can act with greater transparency and promote public trust. They also touched upon the potential for greater collaboration between the FDA and other agencies, including the Center for Medicare and Medicaid Services.

Each panelist concluded by expressing what they believed should be a priority for the FDA. In terms of tobacco marketing, Zettler said she would like the FDA to close the loophole that allows for the marketing of synthetic nicotine products.

Sharfstein hopes to see the FDA do more to promote equity beyond encouraging diversity in clinical trials.

Finally, Kesselheim said he would like to see an off-ramp included in the upcoming PDUFA reauthorization that works to reduce the FDA’s reliance on user fees.