Psychology Program Presents
CANCELED (will be rescheduled at a later date)
Enabling the FDA We Want and Defending the FDA We Have
Thursday, April 4, 2024
Preston Theater
4:00 pm – 5:30 pm EDT/GMT-4
4:00 pm – 5:30 pm EDT/GMT-4
Reshma Ramachandran, Yale School of Medicine
The U.S. Food and Drug Administration (FDA) has an almost seemingly conflicting mission. On one hand, the agency acts as a national regulator, ensuring that medical products including drugs and medical devices are “more effective, safer, and more affordable.” On the other hand, FDA has played a significant role in “helping to speed innovation” through the increased adoption of flexibility in its regulatory standards for approval. Recent controversial approvals have raised questions around this tension, prompting public outcry and calls for the agency to adopt more robust regulatory standards to mitigate the potential patient harms of employing such regulatory flexibility. Amidst this, FDA is currently facing several judicial challenges seeking to undermine its administrative authority and ability to carry out regulatory decisions based on clinical and scientific expertise. This talk will discuss these two circumstances that the FDA faces and what can be done to protect and strengthen the FDA’s role as a national regulator in protecting public health.Reshma Ramachandran, MD, MPP, MHS is a board-certified family physician, health services researcher, and Assistant Professor at Yale School of Medicine. Her research focuses on the realignment of incentives for healthcare stakeholders including pharmaceutical companies, hospitals, and universities towards prioritizing equitable patient access to safe, effective health technologies. She co-directs the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, an interdisciplinary initiative that researches medical product evaluation, approval, and coverage towards advancing policies that improve patient outcomes. Prior to this role, Reshma worked as research faculty as part of the Innovation + Design Enabling Access (IDEA) Initiative at the Johns Hopkins Bloomberg School ofPublic Health, where she focused on policies to address the global challenge of antimicrobial resistance and unaffordable access to prescription drugs. Dr. Ramachandran trained in both medicine at the Alpert Medical School at Brown University and in public policy at the Harvard Kennedy School of Government. She completed her family medicine residency at Kaiser Permanente Los Angeles Medical Center and health services research and policy fellowship at the National Clinician Scholars Program at Yale. Previously, she served as the first PharmFree Fellow with the American Medical Student Association focused on removing the undue influence of pharmaceutical companies on prescribing behavior and medical education. She currently chairs the Doctors for America FDA Task Force. She also is the Board President of Universities Allied for Essential Medicines (UAEM) North America.
For more information, call 845-758-6822, or e-mail [email protected].
Time: 4:00 pm – 5:30 pm EDT/GMT-4
Location: Preston Theater