Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products

Abstract

BackgroundThe U.S. Food and Drug Administration (FDA) 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.

Communicating emerging risks of SGLT2 inhibitors—timeliness and transparency of medicine regulators

“…. discordance can create confusion if the basis for the differing conclusions is not made clear.”41 In addition to detailed explanatory summaries, we think that regulators should provide public access to post-market safety reports submitted by industry to regulators 43. Industry interactions with regulators regarding the interpretation of safety data should likewise be a matter of public record.…”

Systematic overview of Freedom of Information Act requests to the Department of Health and Human Services from 2008 to 2017

“…For example, FDA advisory committee materials used to be confidential until they were the subject of FOIA requests, but the FDA changed its practice to proactively release such materials, which has provided useful information for the public and saved the agency time responding to FOIA requests. Notable types of records that HHS agencies might consider proactively disclosing include for the FDA; clinical study reports, final reports of clinical trials that fulfill postmarketing requirements and commitments, and Risk Evaluation and Mitigation Strategies; for CMS, provider level claims and spending data; and for NIH and CDC, expenditures on preclinical and clinical research and development, agency-held intellectual property, and payments to and from industry [18, 19].…”

Biden’s choice and FDA’s loosening standards of evidence

“…Woodcock has said industry is a “partner” of the agency 1. Sharfstein says that a stronger and more transparent FDA is needed to improve safety surveillance and trust in the agency 23…”