The Senate Committee on Health, Education, Labor and Pensions (HELP) has passed the last of 19 bipartisan pieces of legislation that will become the Senate companion to the 21st Century Cures Act–passed last year by the House of Representatives in a vote of 344-77. 

Sen. Lamar Alexander (R-Tenn.) committee chair, said the innovation legislation would be the most important new law enacted this year because it will "help improve the health of virtually every American." It 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, according to a release. 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 EMRs, reduction in excessive physician paperwork, clarify each patient’s right to own their own medical record and discourage information blocking.

Alexander said his goal is to present this companion legislation to Majority Leader Mitch McConnell (R-Ky.), 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. 

“The lack of NIH funding over the past decade has been devastating to the latest generation of scientists and innovators,” said Tammy Baldwin (D-Wisc.).

This third and final mark-up meeting is part of the effort to “take advantage of this remarkable time in science,” Alexander said.

Five bipartisan bills were approved during the April 6 meeting:

• The FDA and NIH Workplace Authorities Modernization Act will help the FDA and NIH to hire and retain research talent, increase data sharing between different centers at the FDA, collaborate with the private sector for regulatory research, and reduce the administrative burden on researchers. “At a time when there is so much brain power at the FDA and NIH, with exciting new ideas, we need to make sure there is sufficient brain power within those agencies about what to approve and what research makes the most sense for the NIH to be doing,” Alexander said. “The top priority is attracting more talent to their agencies. This bill does a variety of things to create an environment in which they’re more likely to succeed.”
• The Advancing Precision Medicine Act of 2016, which supports the Precision Medicine Initiative’s goal of mapping 1 million genomes and creating a research cohort of accessible health information.
• In the Advancing NIH Strategic Planning and Representation in Medical Research Act, legislators stated that NIH will develop a strategic plan every six years and ensure that research includes women and minorities.
• The Promise for Antibiotics and Therapeutics for Health Act will help to streamline the development of new treatments for individuals infected with superbugs that resist standard antibiotics.
• Researchers with NIH grants today spend 42 percent of their time filling out paperwork. The Promoting Biomedical Research and Public Health for Patients Act allows those researchers to spend more of their time finding life-saving treatments and cures.