The House easily passed the bipartisan “21st Century Cures Act” yesterday. Among its numerous provisions, the bill allocates $4.8 billion over 10 years to the National Institutes of Health in support of the Obama administration’s Cancer Moonshot, BRAIN, and Precision Medicine Initiatives, and creates a Research Policy Board tasked with identifying means of reducing administrative burdens.
Yesterday, the House passed the “21st Century Cures Act” by a vote of 392 to 26, after adopting a manager’s amendment. Some Senate Democrats, namely Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT), have vowed to oppose the bill, arguing that it unduly benefits the pharmaceutical industry. However, the bills’ backers are optimistic that the Senate will pass the legislation and the president will sign it into law before the current Congress ends. The White House says it “strongly supports” the bill, which would provide dedicated funding for three of President Obama’s biomedical innovation priorities: the Cancer Moonshot, BRAIN, and Precision Medicine initiatives.
Bill passes despite scaled-back funding boost
The House has been working on the bill for the past three years, and the final text reflects many compromises made to win the support of both parties, the pharmaceutical industry, patient advocates, and the research community.
Before the vote on the House floor yesterday, the lead Republican sponsor Rep. Fred Upton (R-MI) summarized the underlying motivation for the bill:
Finding cures and boosting research and innovation was absent from any policy to-do list. People didn't seem to care that the gap between biomedical innovation and our regulatory process was widening, or that of the 10,000 known diseases—7,000 of which are rare—there are treatments for only about 500. We needed to change the conversation and restore urgency. And working together, we have.
However, some blasted the decision to significantly reduce the overall funding boost provided to NIH and make it subject to annual appropriations. Rep. Lloyd Doggett (D-TX) explained that he rescinded his support for the bill because of this change:
In a wide and endless desert of support for research funding, even getting a few drops of rain is understandably welcomed by the thirsty. … I voted for the bill when it was on the floor of the House at a previous time. At that point, it promised the hope, after this long drought of almost $10 billion in assured, certain funding... . Now, under this new measure, we have only about a fourth of the funding previously approved in the House, and it is no longer certain money; it is maybe money for the future.
As reported in FYI #144, the initial version of the bill would have provided NIH with $8.75 billion in mandatory funding over a five-year period. The new version provides NIH with $4.8 billion over a ten-year period, and the funding must be approved by appropriators on an annual basis. This change was made to gain the support of fiscal conservatives opposed to establishing new mandatory funding streams.
The NIH Innovation Account established by the bill provides $1.8 billion for the Cancer Moonshot, $1.5 billion for the BRAIN Initiative, $1.4 billion for the Precision Medicine Initiative, and $30 million for a regenerative medicine research program. This funding would be added to the annual discretionary appropriations for NIH. The bill also provides $500 million over nine years to the Food and Drug Administration and $1 billion over two years to address the opioid crisis.
The funding profile for these initiatives is perhaps influenced by the timing of the offsets used to pay for the spending increases. These offsets include the sale of millions of oil barrels from the Strategic Petroleum Reserve and the diversion of money from the Prevention and Public Health Fund established by the Affordable Care Act.
Other items of interest include top-line authorizations, new Research Policy Board
The bill contains numerous other provisions pertaining to NIH, such as authorization of top-level funding and measures to support young scientists, improve research coordination, increase research data sharing, and reduce administrative burden.
The bill authorizes $34.9 billion for NIH in fiscal year 2018, $35.6 billion in FY 2019, and $36.5 billion in FY 2020. Although appropriators often do not match the authorized funding levels, the increases indicate congressional support for raising the base NIH budget higher than the amount that would be provided by the Innovation Fund alone.
Indeed, the pending FY 2017 House and Senate appropriations bills would provide NIH with a $1.25 billion or $2 billion increase, respectively, over the FY 2016 level of $32.3 billion. However, Congress appears likely to extend the current continuing resolution that has fixed spending at FY 2016 levels, meaning that the proposed increase may not materialize this year.
Also of particular note, the bill establishes a Research Policy Board charged with recommending ways to modify and harmonize research regulations across the government with the goal of reducing administrative burdens while maintaining proper oversight. The board would serve as an advisory committee to the White House Office of Management and Budget and have up to 10 federal members, 9 to 12 non-federal members, and sunset at the end of FY 2021. As reported in FYI #80, the National Academies recommended that Congress create such a body, although the Academies proposed a different organizational structure for the board.