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  • Washington Highlights

    BPC Briefing Discusses Development of Cures Companion

    Stephen Heinig, Director, Science Policy
    Anurupa Dev, Director, Science Policy & Strategy

    Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Lamar Alexander (R-Tenn.), House Energy and Commerce Committee Ranking Member Diana DeGette (D-Colo.), and Rep. Michael Bennet (D-Colo.), July 27 spoke at a Bipartisan Policy Center (BPC) briefing that centered on a recently released BPC report entitled, Advancing Medical Innovation for a Healthier America.

    The report recommends accelerating the pace by which drugs and medical devices become available to patients by improving the regulatory environment for approval. The BPC panel included former Sen. Bill Frist, M.D. (R-Tenn.), former Rep. Bart Gordon (D-Tenn.), and several researchers and health advocates. The speakers aired strong support for medical research at the National Institutes of Health.

    The report includes four broad categories of recommendations:

    • Improving the medical product development process, and to ensure patient perspectives are included in the benefit-risk assessment associated with regulatory decision-making;
    • Increasing regulatory clarity regarding the development of a precision medicine framework, health information technology (HIT), and laboratory developed tests (LDT);
    • Strengthening the Food and Drug Administration’s (FDA) ability to carry out its mission; and
    • Improving patient access to medical products for unmet and public health needs.

    Sen. Alexander stated that the HELP committee would closely consider the recommendations as it develops legislation complimentary to the 21st Century Cures Act (H.R. 6), bipartisan legislation developed in the House Energy and Commerce Committee and approved July 10 by the House [see Washington Highlights, July 10].