Senate committee completes consideration of medical innovation legislation

The Senate Health, Education, Labor & Pensions (HELP) Committee took another step forward in their ongoing effort to advance legislation similar to the 21st Century Cures bill that was passed by the House last year. On April 6, the HELP Committee approved several bills of interest to the biomedical research community. But the committee has yet to reach a consensus on funding for the National Institutes of Health (NIH).

Among the legislation passed by the HELP Committee was the Food and Drug Administration and NIH Workforce Authorities Modernization Act (S 2700). This bill removes some of the administrative barriers that make it difficult for federal employees to attend scientific conferences. It also exempts NIH research that relies on voluntary data collection from the Paperwork Reduction Act. This law required NIH to seek permission from the Office of Management and Budget before requesting most types of information from the public, a process that can delay research from moving forward.

The HELP Committee also passed the Promoting Biomedical Research and Public Health for Patients Act to reduce regulatory burden for NIH-funded investigators. This bill recommends a number of actions to reduce regulatory burden on researchers, including efforts to reduce inconsistencies, overlap, and duplication in policies related to the care and use of animals in research as well as reforms of sub-recipient monitoring requirements for multi-site awards. The Federation of American Societies for Experimental Biology included similar recommendations in its Sustaining Discovery Discussion Framework. The HELP bill also calls for the creation of a Research Policy Board that would make recommendations for the harmonization and streamlining of research regulations across federal agencies.

“This legislation will help the NIH eliminate this unnecessary red tape that not only wastes researchers’ time, but also wastes taxpayer dollars the agency could devote to additional multi-year grants for sponsored research to capitalize on this exciting time in science and bring more life-saving cures and treatments to American patients,” said Chairman Lamar Alexander (R-TN).

Two additional bills were also approved by the HELP Committee this week. The Advancing Precision Medicine Act (S 2713) authorizes the effort currently underway at NIH to develop treatments and therapies based on individual variability in genes, environment, and lifestyle. NIH strategic planning would also proceed as per the Advancing NIH Strategic Planning and Representation in Medical Research Act (S.2745), which also seeks to increase diversity among clinical trial participants so that these studies become more representative of patient populations.

In remarks at the end of the markup, Chairman Alexander reiterated his desire to move this set of bills forward as soon as possible. In order to do so, he pledged to work toward a bipartisan agreement on mandatory funding for NIH in order to gain the support of Democrats and allow this legislative package to be brought to the Senate floor.