Researchers Want More Transparency From the US FDA

Author: Johns Hopkins University Bloomberg School of Public Health
Published: 2017/03/18 - Updated: 2023/09/19
Publication Type: Reports and Proceedings - Peer-Reviewed: Yes
Contents: Summary - Main - Related Publications

Synopsis: Researchers create Blueprint for Transparency 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 full report, Blueprint for Transparency at the U.S. Food and Drug Administration, is being released simultaneously online.

Main Digest

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.

"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.

Attribution/Source(s):

This peer reviewed publication pertaining to our FDA News and Approvals section was selected for circulation by the editors of Disabled World due to its likely interest to our disability community readers. Though the content may have been edited for style, clarity, or length, the article "Researchers Want More Transparency From the US FDA" was originally written by Johns Hopkins University Bloomberg School of Public Health, and submitted for publishing on 2017/03/18 (Edit Update: 2023/09/19). Should you require further information or clarification, Johns Hopkins University Bloomberg School of Public Health can be contacted at the jhsph.edu website. Disabled World makes no warranties or representations in connection therewith.

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