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Washington Highlights

AAMC Supports FDA Proposal on Access to “Non-Summary” Data from Safety and Efficacy Studies

August 9, 2013—The AAMC submitted an Aug. 5 comment letter  in support of a Food and Drug Administration (FDA) proposal to make available de-identified and masked data from safety and efficacy studies to researchers outside the agency. In its comments, the AAMC supports making “non-summary information, including patient-level data, available to qualified researchers, providing there are requisite safeguards for protection of privacy and sensitive proprietary or business information.” 

The proposal, published in the June 4 Federal Register, described the initiative as part of an ongoing effort to make the agency’s operations more transparent and to harmonize regulations relative to drug and device approval with other aspects of the nation’s research and development system.  The FDA invited public comments on the proposal, specifically on necessary requirements for sufficiently “masking” product, business, or other proprietary information in any released data.  For protection of personal health information, the FDA would rely primarily on the Health Insurance Portability and Accountability Act (HIPAA) de-identification standards, although the agency asked for comments on whether further standards are necessary. 

The AAMC focuses its comments more generally on the proposal’s rationale, noting “Our goal for transparency is to strengthen the clinical research ecosystem broadly, and to provide encouragement and incentive for the different actors or components of that system, including the firms and organizations that sponsor and conduct clinical studies, the volunteers who participate in such studies, and the networks of investigators who contribute to ongoing discovery and innovation.” 

The AAMC also agrees with the FDA’s assertion that “the contribution of patients who participate in clinical trials should be maximized for the benefit of society,” which expanded access to safety and efficacy data would help achieve. 

It is not clear from the notice if or when a final process for release of these data would be implemented or whether further changes in regulation would be needed to help effect such a program.

Contacts:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

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For More Information

Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org