Senate HELP Committee Passes Final Innovation Bills
The Senate Health, Education, Labor and Pensions (HELP) Committee has voted out five bills that completes the Senate’s work on companion legislation to the House’s 21st Century Cures Act that passed last year. What is missing is an agreement on mandatory funding for the National Institutes of Health. However, HELP chairman Lamar Alexander (R-TN) said he is working on finalizing a bipartisan funding agreement that will be included when the legislation is handed to Senate majority leader Mitch McConnell (R-KY) for consideration on the Senate floor.
“Because our Innovation — or ‘Cures’ — legislation will affect virtually every American, it will be the most important new law enacted this year,” Alexander said at the hearing. “The legislation would create a breakthrough path for new medical devices like the breakthrough drug path approved in 2012 that has already attracted 384 applications and led to 39 approvals. It would give the FDA new authority to attract talented researchers, and reduce the administrative burden on NIH and researchers. It would target rare diseases, including diseases resistant to antibiotics. It would allow NIH to require researchers who use NIH funds to share their data. It would encourage interoperability of electronic medical records, reduction in excessive physician paperwork, clarify each patient’s right to own their own medical record, and discourage information blocking.”
Alexander said that his goal is to present the companion legislation to McConnell, along with a bipartisan “NIH Innovation Fund,” which would provide a surge of one-time funding for targeted NIH priorities, including the president's Precision Medicine Initiative, the vice president’s National Cancer Moonshot Initiative, Young Investigator Corps, Big Biothink Awards and the BRAIN Initiative. He added: “With its 21st Century Cures Act passed last year, the House voted 344 to 77 to provide $8.8 billion in paid-for mandatory funding to support such NIH priorities. We continue to work to find an amount that the House will agree to, the Senate will pass and the president will sign.”
The following bipartisan bills were passed by the committee: (S. 2700) FDA and NIH Workforce Authorities Modernization Act: This will help FDA and NIH attract and retain the talent they need to handle new developments headed their way for research and review — a top priority for the heads of both agencies.(S. 185) Promise for Antibiotics and Therapeutics for Health Act: The bill is intended to shorten the development of new treatments to help those infected with life-threatening superbugs.(S. 2713) Advancing Precision Medicine Act of 2016: The bill would support the president’s Precision Medicine Initiative to map one million genomes and make the information available to researchers, who in turn will be required to share their research – all to help find treatments for diseases sooner.(S. 2745) Advancing NIH Strategic Planning and Representation in Medical Research Act: The bill would require NIH to come up with a strategic plan every six years, and also helps ensure that scientists are including women and minorities in their research and reporting on the differences they find.(S. 2742) Promoting Biomedical Research and Public Health for Patients Act: The bill would allow researchers at the NIH to spend more time finding life-saving treatments and cures and less time on paperwork.
By voice vote, the committee also adopted an amendment on FDA good guidance practices offered by Sen. Pat Roberts (R-KS) that would require the agency to explain why a guidance document is the proper route in lieu of formal rulemaking. Roberts noted that FDA has increased its use of guidance documents, with over 600 issued since 2007, and many are misused to effect policy changes which should be reserved for regulations. Ranking member Patty Murray (D-WA) opposed the amendment. Murray said she addressed the issue with FDA commissioner Robert Califf, who had concerns the amendment would slow down the “already slow” guidance process and would delay needed information for industry.