Senate Medical Innovation Bills: Overview and Comparison with the 21st Century Cures Act (H.R. 6)

Summary

Both the House and the Senate are considering legislation to support medical innovation, primarily through reforms to the National Institutes of Health (NIH) and changes to the drug, biologic, and device approval pathways at the Food and Drug Administration (FDA). On February 3, 2015 Senators Lamar Alexander and Patty Murray, chairman and ranking Member of the Committee on Health, Education, Labor and Pensions, announced the start of a bipartisan initiative to “examine the process for getting safe treatments, devices and cures to patients and the roles of the [FDA] and the [NIH] in that process.” This initiative culminated in a package of 19 bipartisan bills that were reported out of the Senate Health, Labor, Education, and Pensions (HELP) Committee in a series of three executive sessions held on February 9, 2016; March 9, 2016; and April 6, 2016.

The Senate’s medical innovation package is that chamber’s companion effort to the House’s 21st Century Cures initiative, which culminated in the House passage of H.R. 6, the 21st Century Cures Act, on July 10, 2015, on a vote of 344 to 77. H.R. 6 is the result of a series of hearings and roundtable meetings hosted by the House Energy and Commerce Committee dating back to spring 2014. While consisting of many different provisions, H.R. 6 is primarily focused on efforts to increase strategic investments in medical research at NIH and change some aspects of how the FDA executes its regulatory oversight mission with regard to the review and approval of new drugs, biologics, and medical devices.

This report provides for each of the bills in the Senate medical innovation package (1) background on the issue, or issues, addressed by the bill, including a summary of relevant current law; (2) a summary of the bill’s provisions; and (3) where applicable, identification of comparable provisions in H.R. 6 that address the same topic. For a summary of all the provisions in H.R. 6, as passed by the House, including an explanation of how the bill would change current law, see CRS Report R44071, H.R. 6: The 21st Century Cures Act.