Research Ethics and Policy Series (REPS): The Burden of Uncertainty: Raising Regulatory Standards to Improve Health Equity with Reshma Ramachandran, MD, MPP, MHS

The Burden of Uncertainty: Raising Regulatory Standards to Improve Health Equity

Reshma Ramachandran, MD, MPP, MHS
Assistant Professor of Medicine (General Medicine),
School of Medicine, Yale University

Co-sponsored by the Department of Family Medicine and Community Health at the Perelman School of Medicine

Lunch is provided for in-person attendees.
Livestreaming available via Zoom.

Reshma Ramachandran, MD, MPP, MHS is a board-certified family physician and health services researcher. 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.

Recently, the U.S. Food and Drug Administration (FDA) has been placing greater emphasis and implementing reforms focused on improving health equity. The focus of the reforms has been largely on increasing representation in clinical trials, enhancing transparency and access to available data on the effect of medical products on minority populations, and promoting health and safety communication to these populations. Concurrently, FDA continues to increasingly adopt regulatory flexibility in their review process, accepting less rigorous evidence as the basis of approval of novel medical products. In the case of accelerated approval, the agency allows for residual uncertainty at the time of approval, but then requires sponsors to complete additional studies that confirm clinical benefit in a timely manner; should these not be completed or if the studies yield negative results, FDA can withdraw these drugs from the market. However, the expanded and more flexible use of this pathway by the FDA has raised questions about which communities will bear the burden of such uncertainty and whether this may in fact exacerbate health disparities.

In this presentation, Dr. Ramachandran will discuss trends in FDA’s adoption of regulatory flexibility in the approval of novel medical predicts, the implication of such policies, and proposals to center health equity in regulatory decision-making.