Abstract
BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation.
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DOI 10.1177/1073110517750615
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Disclose Data Publicly, Without Restriction.Peter Doshi & Tom Jefferson - 2017 - Journal of Law, Medicine and Ethics 45 (s2):42-45.
FDA and the Marketplace of Ideas for Medical Products.Nathan Cortez - 2017 - Journal of Law, Medicine and Ethics 45 (s2):39-41.
Transparency at the U.S. Food and Drug Administration.Robert M. Califf - 2017 - Journal of Law, Medicine and Ethics 45 (s2):24-28.
The Case for Disclosure of Biologics Manufacturing Information.Yaniv Heled - 2019 - Journal of Law, Medicine and Ethics 47 (S4):54-78.
FDA Transparency in an Inescapably Political World.Daniel Carpenter - 2017 - Journal of Law, Medicine and Ethics 45 (s2):29-32.

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