Senate HELP Committee Holds Final Innovation Initiative Mark-up

April 10, 2016

On April 6, the Senate Health Education Labor and Pensions (HELP) Committee completed their third and final mark-up of bills related to their “innovation initiative” agenda, passing five additional pieces of legislation with bipartisan support. Chairman Lamar Alexander (R-Tenn.) has indicated that a companion to the House-passed 21st Century Cures Act could be on the Senate floor this year, although issues involving NIH and FDA funding remain unresolved.

Several of the bills considered at the April 6 markup are based on or contain elements consistent with ideas advocated by CLSA (through our legacy CHI organization) in formal comments submitted to the Committee last year.

Legislation passed by the committee include:

  • S. 2700, FDA and NIH Workforce Authorities Modernization Act: This bill will help the FDA and NIH attract and retain the talent needed to best advance promising scientific research and new medicines and technologies. This is a top priority for the leadership of both agencies.
  • S. 185, Promise for Antibiotics and Therapeutics for Health Act: This bill will shorten the development timeline of new treatments to help those infected with life-threatening superbugs.
  • S. 2713, Advancing Precision Medicine Act of 2016: This will support the president’s Precision Medicine Initiative to map 1 million genomes and make the information available to researchers who in turn will be required to share their research in the mission find treatments for diseases sooner.
  • S. 2745, NIH Strategic Plan and Inclusion in Clinical Research: This bill requires NIH to develop a strategic plan every 6 years, and also includes provisions to 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: This bill serves to reduce the amount of time and effort researchers spend on paperwork requirements, allowing them to spend more time on actual research.

As mentioned above, the intention is that the bills passed by the HELP Committee over the past several months will be consolidated on the Senate floor into an omnibus bill, pass the Senate, and then go to conference with the 21st Century Cures bill passed by the House last summer.  However, as is being widely reported, there is concern over a lack of funding resources for FDA and NIH to carry out the substantial new responsibilities envisioned by both House 21st Century Cures and the Senate Innovation measures. Senate HELP chairman Alexander has acknowledged that committee Democrats will look to block the legislation unless increased funding for NIH is provided in the package. However, given the difficulty in the current political landscape in finding the off-sets needed to pay for new funding, it remains unclear how increased appropriations would be accomplished.

For questions, please contact Jenny Carey, CLSA’s Vice President of Federal Government Relations and Alliance Development (