On July 10, the House of Representatives passed the bipartisan 21st Century Cures Act (H.R. 6) by a 344 to 77 vote. In addition to reauthorizing the National Institutes of Health (NIH) for three years, the bill as passed would provide $9.3 billion in advanced appropriations for fiscal years (FY) 2016-2020 for a new NIH Cures Innovation Fund and $110 million annually for the Food and Drug Administration’s (FDA) regulatory modernization activities. (See COSSA’s analysis of the bill here.)
Several amendments were considered during the floor debate:
The House rejected, by a vote of 141 to 281, an amendment by Representatives Dave Brat (R-VA), Tom McClintock (R-CA), Scott Garrett (R-NJ), Marlin Stutzman (R-IN) and Scott Perry (R-PA) that placed passage of H.R. 6 in jeopardy by making the Cures Innovation Fund to support NIH and FDA a discretionary program instead of a mandatory program as proposed by the bill. Such a designation would have required the fund to be automatically subject to sequestration. There was added concern that the Cures Innovation Fund would further divert funding from other discretionary health programs and activities within the jurisdiction of the Labor, Health and Human Services Appropriations Subcommittee.
An amendment by Representatives Barbara Lee (D-CA), Jan Schakowsky (D -IL), and Yvette Clarke (D-NY) that would have removed policy riders from the bill was rejected by a vote of 175 to 275. The amendment would have removed language codifying existing prohibitions on federal funding for abortions inserted in the bill after the Committee mark up.
The House adopted by voice vote an amendment offered by Representatives Todd Young (R-IN) and Andy Harris (R-MD) which provides NIH the authority to conduct a prize program designed to “incentivize health innovation by offering competitors the chance to win a prize for creating breakthrough research and technology.”
An amendment by Representative Joaquin Castro (D-TX) that “ensures underrepresented individuals, such as women and minorities, are included in the Supporting Young Emerging Scientists Report” was unanimously agreed to by voice vote.
The House also agreed, via voice vote, to an amendment offered by Representative Louise Slaughter (D-NY) which directs the Centers for Disease Control and Prevention to “conduct a study to determine how additional payments are affecting the development of drug resistance.”
Finally, an amendment by Representative Shelia Jackson Lee (D-TX) was agreed to by voice vote directing the “Secretary of Health and Human Services to conduct outreach to Historically Black Colleges and Universities, Hispanic Serving Institutions, Native American Colleges, and rural Colleges to ensure that health professionals from underrepresented populations are aware of research opportunities.”
White House Issues Statement of Administration Policy
Ahead of the bill’s passage in the House, the White House issued a Statement of Administration Policy (SAP) expressing its appreciation for the bipartisan effort to support medical research.
While the Administration acknowledged H.R. 6’s support for the President’s Precision Medicine Initiative and for improving the drug development and approval process by incorporating patients’ voices into FDA decision-making, it expressed concern about providing additional funding for NIH and FDA without addressing sequestration more broadly. According to the SAP, “Sequestration funding levels threaten not only NIH research, but also other investments in innovation. They threaten health care access and quality, not only by underfunding biomedical research, but also by underfunding key public health and mental health programs.”
Meanwhile, the Senate is on a slower timeline in its consideration of a comparable measure. Chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, Lamar Alexander (R-TN), has noted that the HELP Committee is also working on a bipartisan basis to introduce a companion measure bill (See Update, March 24, 2015). At a May 28-29 special session of the NIH Advisory Council to the Director (ACD) Precision Medicine Initiative Working Group, Sen. Alexander reported that the committee is currently holding hearings and have staff working groups examining several areas of the discovery and approval process to identify the “five or six things that we might do in the next few months.” There is also a subgroup working on electronic health records (EHR). Alexander announced a goal of producing legislation by the end of the year (see Update, June 6, 2015). Given that the respective versions of the bill would then need to be reconciled by a conference committee, final passage of a measure that accommodates the perspectives of both houses this year remains uncertain.
Scientific Community Weighs In
COSSA has joined the scientific community in sending a letter to the Senate HELP Committee providing input and recommendations designed to enhance the role of NIH as it continues to work on their bipartisan innovation initiative. The letter offers recommendations representing the consensus of the organizations and institutions on the need to:
- Stabilize the NIH budget through sustained increases in appropriations
- Affirm existing NIH support for interdisciplinary scientific research
- Grant NIH “carry-over” budget authority
- Ease the burdensome travel restrictions for federal researchers
- Address regulatory burden