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  • Washington Highlights

    Senate Committee Works to Finalize Biomedical Innovation Legislation

    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach

    The Senate Health, Education, Labor, and Pensions (HELP) Committee April 6 approved several bipartisan bills as part of its piecemeal approach to produce companion legislation to the House-passed 21st Century Cures Act (H.R. 6). This was the third and likely final hearing marking up medical innovation legislation [see Washington Highlights, March 11, 2016].

    In his opening remarks, Committee Chair Lamar Alexander (R-Tenn.) highlighted the HELP committee’s work on the fifty bipartisan proposals his committee has considered over the course of three markups, and noted that the Senate’s “Innovation legislation” would “give the FDA new authority to attract talented researchers, and reduce the administrative burden on NIH and researchers.” Sen. Alexander did note that while this will likely be the final hearing, there are several outstanding issues remaining before the full Senate will consider the legislation, including issues such as mandatory funding for NIH and FDA regulations of laboratory developed tests (LDTs).

    Ranking Member Patty Murray (D-Wash.) reiterated the chair’s comments on the importance of including a “surge” of funding for NIH in order for the innovation legislation to be considered before the full Senate. Senator Murray also noted that the committee has found common ground on “ways to strengthen our nation’s health IT infrastructure, support the next generation of scientists and researchers, and help incorporate patient feedback into FDA decision making…”

    The committee approved the Promoting Biomedical Research and Public Health for Patients Act (S. 2742) to reduce the regulatory burden on research institutions and scientists.

    In an April 4 letter endorsing the legislation, AAMC President and CEO Darrell Kirch, M.D., said the bill “appropriately incorporates many of the recommendations of the National Academies’ report Optimizing the Nation’s Investment in Academic Research. The myriad regulations, policies, guidance documents, and funding requirements have increased and complicated the regulatory oversight of federally funded research and we agree with the National Academies’ assertion that this system should be ‘critically examined and recalibrated’.”

    Supporting the bill’s approach, Dr. Kirch said “provides some direction and clearly sets forth the objectives of the review and revision of specific rules and the regulatory framework overall, but is not so prescriptive that it prevents the NIH from identifying alternative solutions that could accomplish the same goals.”

    Key provisions of S. 2742 include: the review of the rules related to the review of financial interests and reporting of financial conflicts of interest; the provision to reduce the administrative burden related to subrecipient monitoring by primary awardees of NIH grants; and the requirement for systematic review of similar regulations or policies issued by different funders, including for laboratory animal research.

    The committee also approved several other bills, including:

    • The FDA and NIH Workforce Authorities Modernization Act (S. 2700), sponsored by Sens. Alexander (R-Tenn.) and Murray (D-Wash.);
    • The Promise for Antibiotics and Therapeutics for Health Act (S. 185), sponsored by Sens. Hatch (R-Utah) and Bennet (D-Colo.);
    • The Advancing Precision Medicine Act of 2016 (S.2713), sponsored by Sens. Alexander (R-Tenn.) and Murray (D-Wash); and
    • The Advancing NIH Strategic Planning and Representation in Medical Research Act (S.2745), sponsored by Sens. Collins (R-Maine), Warren (D-Mass.), Kirk (R-Ill.), Baldwin (D-Wis.), Alexander (R-Tenn.), and Murray (D-Wash.).