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  • Washington Highlights

    Senate Panel Continues Examination of Medical Innovation

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

    The Senate Health, Education, Labor, and Pensions (HELP) Committee April 28 held a hearing entitled “Continuing America’s Leadership, the Future of Medical Innovation for Patients.”

    Committee Chair Lamar Alexander (R-Tenn.) noted this was the panel’s third hearing “examining how we can get safe drugs, medical devices and treatments from the discovery process through the regulatory process into medicine cabinets, and into doctor’s offices for patients who need them.”

    Senator Patty Murray (D-Wash.), the committee’s ranking member, said, “I see maintaining our country’s central role in the life sciences as a top priority. And I believe we need to be doing everything we can to make sure the next life-saving, world-changing cures and treatments are developed right here in the United States.”

    Christopher Austin, M.D., National Center for Advancing Translational Sciences (NCATS) Director at the National Institutes of Health (NIH), presented several examples of the institute’s efforts to improve the process for translating fundamental understanding to interventions that will improve the health of patients, including the Tissue Chip for Drug Screening and the Discovering New Therapeutics for Existing Molecules programs.

    In addition, he described how the 62 Clinical and Translational Science Awards (CTSA) sites serve as research hubs to support a national network for clinical and translational studies. He noted the CTSA program also is working on improving participant recruitment to clinical trials and to leverage electronic health records to speed clinical research.

    Roderic Pettigrew, Ph.D., M.D., director, National Institute of Biomedical Imaging And Bioengineering (NIBIB), presented a video showing a broad view of NIBIB-supported technologies at various stages of development from proof of concept to commercialization. These included tissue engineered human liver that can be implanted in a mouse to evaluate candidate drugs for toxicity, a hand-held MR system that is capable of detecting a variety of targets from bacteria to viruses to components of cancer cells, and a biodegradable system to simplify vaccinations.

    Janet Woodcock, M.D., director, Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told the committee that “a large number of innovative new medicines are being approved and are in the pipeline. And in fact, U.S. patients do, in a vast majority of cases, have first access to these treatments.”

    “But we do need to continue to improve the efficiency of drug development if we're going to continue to get drugs to patients rapidly and affordably,” she noted.

    Jeffrey Shuren, M.D., J.D., director, FDA’s Center for Devices and Radiological Health, testified on the agency’s work to promote patient access to innovative medical devices while ensuring appropriate patient protection.

    Chairman Alexander told the witnesses, “Our purpose here is to enable you, not to slow you down. We want to align federal policies … with an opportunity for more, not less, safe innovation. So I would invite each of you to form your own internal red team for red tape…. [T]his is an opportunity to clear the clutter out of the way and to take advantage of a rapidly changing landscape.”

    Senator Elizabeth Warren (D-Mass.) said, “Medical research funding in this country is in crisis…. [T]he NIH needs more resources, we've got to keep this pipeline going.” She added, “[I]f we want medical innovation in this country, we need to double down on support for NIH. If we want to improve the quality of life for Americans and reduce federal health care spending, we need to double down on NIH spending.”

    The committee has scheduled a hearing on “Continuing America’s Leadership: Realizing the Promise of Precision Medicine for Patients” for May 5.