21st Century Cures Legislation Unanimously Approved by Energy & Commerce Committee, Next Action on House Floor

May 21, 2015


On May 21, the House Energy & Commerce Committee unanimously passed H.R. 6, the 21st Century Cures Act, by a vote of 51-0. This landmark legislation represents more than a year of congressional activity and stakeholder engagement in an effort to modernize biomedical discovery, development and delivery to bring new therapies and cures to patients.

CLSA is strongly supportive of the legislation passed by the committee today and we are proud to report that several of our recommendations and priority policy initiatives were included in the legislation, including: several reforms to promote public-private and peer-to-peer collaboration amongst federal researchers and reduce administrative burdens to enable more of a researcher’s time can be dedicated to science; a provision to protect FDA user fees from future sequestration; and an extension of the pediatric rare disease priority review voucher program for four more years.

We look forward to continuing to work with congressional leadership to advance this legislation and ensure that it remains supportive of continued biomedical investment and innovation.

The 21st Century Cures initiative entered its legislative phase with the release of a discussion draft last January. This first draft included a number of the recommendations CLSA made in our October 2014 comments to the committee, where we focused on the “discovery” component of the initiative. After months of work that included incorporating feedback from a broad range of stakeholders, a second discussion draft was released on April 29 with strong bipartisan support from the initiative’s co-chairs, Energy & Commerce Committee Chairman Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), and Full Committee Ranking Member Frank Pallone (D-N.J.), Health Subcommittee Chairman Joe Pitts (R-Penn.), and Health Subcommittee Ranking Member Gene Green (D-Texas). The second discussion draft once again echoed several of CLSA’s proposals, and also proposed to increase support for the NIH through new mandatory funding stream of $2 billion a year for five years. A legislative hearing was held on April 30, in which Administration witnesses offered their perspectives on the document.

A third draft of the legislation was released May 13; this version of the legislation was considered at a markup by the Health Subcommittee the following day (May 14). Notably, this third version of the legislation again retained CLSA’s recommendations and the new funding for NIH, and also added two new provisions of which we are supportive, pertaining to incentives for the development of therapies for rare and/or pediatric conditions.

Finally, on May 19 and 21 the full Energy & Commerce Committee marked up and unanimously approved a final legislative package; the measure may be considered by  the House Committees on Appropriations, Budget, Judiciary, and Ways & Means before it will be considered on the House Floor this summer.

As this legislative process continues, CLSA will advocate for our priority “discovery” proposals contained in the draft, along with the “development” and “delivery” priorities of partner stakeholders, in outreach to the California delegation and the Energy & Commerce Committee.

Click here for our statement lauding the passage of the 21stCentury Cures Act.