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  • Washington Highlights

    AAMC Submits Comments to the FDA on the Review of Existing Regulations and Requirements

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel
    Daria Grayer, Director, Regulation and Policy

    The AAMC Feb 5 submitted a letter to the Food and Drug Administration (FDA) in response to a request for comments on ways to identify regulations and related paperwork requirements that could be “modified, repealed, or replaced” under Presidential Executive Order (EO) 13771, “Reducing Regulation and Controlling Regulatory Costs” and EO 13777, “Enforcing the Regulatory Reform Agenda” [see Washington Highlights, Feb. 10, 2017 and March 3, 2017].

    The AAMC’s comments emphasize the importance of collecting and using credible evidence about a regulation’s impact and burden as a framework for federal agencies and departments to review their regulations, policies, and programs. The association underscores this need, citing recent reports from the AAMC, the National Academy of Sciences, Engineering and Medicine [see Washington Highlights, Sept. 25, 2015], the Government Accountability Office, and the Commission on Evidence-Based Policymaking [see Washington Highlights, Nov. 18, 2016].

    In its letter, the AAMC also urges the FDA to further align its human subject protections regulations with the Department of Health and Human Service’s revised Federal Policy for the Protection of Human Subjects (“Common Rule”) and strongly encourages the FDA to use the recently issued six month implementation delay to the revised Common Rule [see, Washington Highlights, Jan. 19) to initiate and finalize rulemaking to harmonize the FDA regulations. The AAMC also recommends that the FDA review and streamline its regulations and policies related to the disclosure and reporting of financial conflicts of interest as required by Section 2034 of the 21st Century Cures Act (P.L. 114-255).