21st Century Cures Initiative
Update: House Passes 21st Century Cures Bill with Strong Bipartisan Support
Bill provides significant, mandatory funding to NIH and FDA
On July 10, 2015, the U.S. House of Representatives passed H.R. 6, the 21st Century Cures Act, by a vote of 344-77, with twelve members not voting. This vote concluded work begun more than a year ago by the House Energy & Commerce Committee under the leadership of Chairman Fred Upton (R-Mich.) and Ranking Member Diana DeGette (D-Colo.) and continued the show of bipartisan support for medical research within Congress.
In addition to legislation aimed at modernizing the clinical trial process , this bill would create an Innovation Fund that would provide mandatory funding of $8.75 billion ($1.75 Billion per year) to the National Institutes of Health (NIH) in fiscal years 2016 – 2020. The bill also creates a Cures Innovation Fund to provide $550 million in mandatory funding ($110 million per year) to the Food and Drug Administration (FDA) over the next five fiscal years. In a key vote, an amendment offered by Rep. Dave Brat (R-Va.) that would have shifted the funding for the NIH and FDA from mandatory to discretionary was defeated 141-281. Had this amendment passed, it could have undermined the ability of the bill to provide a measure of stability to NIH and FDA funding.
In a letter to Chairman Upton and Rep. DeGette, the AACR expressed our congratulations on the final passage of the bill and commended the open and bipartisan process by which the bill was deliberated, written, and ultimately passed. Our attention now shifts to the Senate, where the Committee on Health, Education, Labor, and Pensions is working on the "Innovation for Healthier Americans" initiative. This initiative, which was announced early this year, is expected to align with the 21st Century Cures bill and address many of the same challenges as that bill. Therefore, it is critical that the medical research advocacy community continues to emphasize the importance of support for both the NIH and the FDA in the form of mandatory, robust, and predictable funding.
Earlier on May 21, 2015, the U.S. House Energy & Commerce Committee unanimously the 21st Century Cures bill by a vote of 51-0. This vote capped more than a year of work by the committee to develop legislation aimed at supporting precision medicine, encouraging medical innovation, supporting research, and delivering treatments more quickly to patients. The bipartisan effort on the part of the committee to put together a bill with multiple opportunities for public input was especially commendable.
The 21st Century Cures Initiative had been the subject of discussion within the AACR and the larger medical research community because of its focus on the funding activities at the National Institutes of Health (NIH), regulatory activities of the U.S. Food and Drug Administration (FDA), and efforts to modernize the clinical trial process.
Prior to the May 21 mark up, the committee released a discussion draft of the bill on which the AACR provided
extensive comments. Many of the concerns expressed in these comments were addressed when the final version of the bill was presented and voted upon in the committee. In an op-ed to the Cancer Letter, José Baselga, president of the AACR and William S. Dalton, chair of the AACR Science Policy and Government Affairs Committee, remarked that the process was a "Model for an Open and Honest Conversation."
On Sept. 9, 2014, former AACR President Charles Sawyers, MD testified before the House Energy and Commerce committee, reiterating the AACR's position on the regulation of laboratory-developed tests. This issue, while not contained in subsequent drafts of the 21st Century Cures bill, had originally been discussed for inclusion.
Full Hearing: 21st Century Cures: Examining the Regulation of Laboratory Developed Tests. Jump to Dr. Saywers's testimony.