Psychology Program Presents

Enabling the FDA We Want and Defending the FDA We Have

The US Food and Drug Administration (FDA) has a 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, the 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, and the 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 the opposing 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 codirects the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, an interdisciplinary initiative that researches medical product evaluation, approval, and coverage aligned with the goal of advancing policies that improve patient health and healthcare.

For more information, call 845-758-6822, or e-mail [email protected].

Time: 4:00 pm EST/GMT-5

Location: Reem-Kayden Center Laszlo Z. Bito '60 Auditorium

Subscribe: Save this Event: Subscribe / .ics File