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FEDERAL | Senate Wrapping Up Work on Innovations Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee held its last of three markups of biomedical innovations legislation. In this last hearing the Committee advanced five bills: the FDA and NIH Workforce Authorities Modernization Act, the Promise for Antibiotics and Therapeutics for Health (PATH) Act, the Advancing Precision Medicine Act of 2016 Act, the Advancing NIH Strategic Planning and Representation in Medical Research Act and the Promoting Biomedical Research and Public Health for Patients Act. Making for a total of 19 bipartisan bills to comprise the Senate's work on medical innovation.

Chairman Alexander stated that the committee considered as many as 50 proposals. The progress was hailed by leadership of the House Energy and Commerce Committee, who spearheaded the companion 21st Century Cures Act that passed with bipartisan support last year. Negotiations on a deal for new mandatory funding for the National Institutes of Health (NIH) are still ongoing, and have been the largest point of contention in the Senate Innovations Initiative. Support for the Innovations Initiative from HELP Democrats has been contingent on the inclusion of new mandatory funding for the NIH and Food and Drug Administration (FDA). Chairman Lamar Alexander (R-TN) has expressed support for NIH mandatory funding targeted to specific initiatives – the Cancer Moonshot, the Precision Medicine Initiative, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, the young investigator corps, and Big Biothink Awards – but because funding offsets are likely to come from outside of HELP's jurisdiction, Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ranking Member Ron Wyden (D-Ore.) are also involved in the negotiation. The 21st Century Cures Act included $9 billion for the NIH and FDA.

Sen. Alexander has said that a completed package could be ready for the floor very soon, and that he has received assurances from Majority Leader Mitch McConnell (R-KY) that he will put the bill on the floor when the work is completed.