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March 13, 2017

More Transparency at FDA Needed, Researchers Say

Writing in JAMA, group outlines recommendations for release of regulatory information, analysis and study data

As the new administration considers the future direction of the Food and Drug Administration, a group of leading researchers has created a Blueprint for Transparency at the agency to advance the development of safe and effective new products.

The researchers include senior faculty from the Johns Hopkins Bloomberg School of Public Health, Harvard Medical School/Brigham and Women’s Hospital, Yale Medical School, and Yale Law School. The project was organized by Joshua Sharfstein, MD, professor of the practice at the Bloomberg School.

Sharfstein and Michael Stebbins, PhD, of the Laura and John Arnold Foundation, have authored an overview of the Blueprint in JAMA, released online March 13. The full report, Blueprint for Transparency at the U.S. Food and Drug Administration, is being released simultaneously online on the Bloomberg School's website.   

“FDA is more than an agency that makes regulatory decisions,” says Sharfstein, a former FDA principal deputy commissioner. “It is also a repository for scientific analysis and data that, if more widely available, would improve understanding of existing therapies, the pharmaceutical pipeline and opportunities for innovative product development.”

The report makes 18 recommendations in five principal areas:

All of the Blueprint’s recommendations can be implemented by FDA without new legislation from Congress, and all respect legal protections for trade secrets.

“Enhancing Transparency at the U.S. Food and Drug Administration: Moving Beyond the 21st Century Cures Act” was written by Joshua M. Sharfstein and Michael Stebbins. The full Blueprint for Transparency was written by the FDA Transparency Working Group, which includes Sharfstein as well as James Dabney Miller, Anna L Davis, Caleb Alexander, Brian Smith and Anam Chaudry of the Bloomberg School; Joseph S. Ross of Yale Medical School; Margaret E. McCarthy of Yale Law School; and Aaron Kesselheim of Brigham and Women’s Hospital/Harvard Medical School.

The Blueprint for Transparency is supported by a grant from the Laura and John Arnold Foundation.

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Media contacts for the Johns Hopkins Bloomberg School of Public Health: Stephanie Desmon at 410-955-7619 or sdesmon1@jhu.edu and Barbara Benham at 410-614-6029 or bbenham1@jhu.edu.