Ohio State and Partners Secure Grant to Inform Future Vision of FDA

Researchers at The Ohio State University Moritz College of Law and partner universities were recently awarded a grant from Arnold Ventures to support a multi-faceted research project, titled “A Principles-Based Approach to Rebuilding and Reenvisioning FDA.” The research team will analyze the history of reforms to the U.S. Food and Drug Administration (FDA) to identify key themes and policy choices, and convene leading FDA stakeholders to develop principles to guide future reforms, with a focus on FDA-regulated pharmaceuticals, devices, and other medical products. 

“The work of FDA is vital for the health and well-being of the American people and for driving biomedical innovation,” said Patricia Zettler, the John W. Bricker Professor of Law at Moritz and principal investigator (PI) for the project. “We're at an inflection point in the work of the FDA where the public and policymakers are paying substantial attention. This makes it an opportune time to carefully study the Agency and investigate how its legal authority, implementation of that authority, and operations might be improved.” 

The team includes Holly Fernandez Lynch, Associate Professor of Medical Ethics at the University of Pennsylvania Perelman School of Medicine, and Reshma Ramachandran, Assistant Professor at Yale University School of Medicine and Co-Director of the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT). The research is designed to inform real-world policy discussions among lawmakers, agency leaders, regulated industry, and the public, and builds on the team’s prior collaboration. 

“The most exciting thing about this project is its potential to affect policy conversations in ways that can have a lasting benefit for public health,” said Professor Zettler. “I’m grateful for Arnold Ventures’ support for this kind of impactful research, and for the opportunity to collaborate with Professor Fernandez Lynch and Dr. Ramachandran, who bring not only FDA expertise but medical, bioethics, and policy expertise to the work.”