Cures Act Provides Research Funding, Direction

The 21^st Century Cures Act was signed by President Obama on Tuesday and is broadly intended to facilitate the research, development and transfer of medical discoveries in order to better-address diseases affecting American people. While the bill has received mainstream coverage for its bipartisanship – the core authors were two Democrats and two Republicans – and billions in new research spending – more than $5 billion in authorizations – the text also contains potentially significant changes for federally-supported medical research policy.

Funding

The bill is achieving significant attention for its appropriation of new research dollars. The National Institutes of Health will receive $4.8 billion over 10 years, distributed through four innovation projects: precision medicine, brain research, cancer research and adult stem cells. The Food and Drug Administration is appropriated an additional $500 million of funding over 10 years, primarily to accelerate drug and device access.

This newly allocated funding is factored into NIH’s reauthorization through FY 2020, which is also part of the Cures Act. NIH is authorized for a budget increase from $32.3 billion in FY 2016 to $34.9 billion in FY 2018, $35.6 billion in FY 2019 and $36.5 billion in FY 2020 (NIH’s budget for FY 2017 will likely be about $32.6 billion). The levels allow for additional new funding for NIH as the three years of authorizations include a total of more than $8 billion beyond both the FY 2016 funding level and the Cures Act funding. Of course, these authorizations will need to be appropriated during each year’s budget process and may not match these levels.

Policy

The overall objective of the Cures Act is to improve the efficiency and impact of the discovery-to-treatment process for drugs and medical devices. True to this goal, the text contains numerous statements about decreasing regulation, improving strategy and increasing collaboration. For example:

• The Precision Medicine Initiative encourages the Secretary of the U.S. Department of Health and Human Services to coordinate with other agencies and to utilize private partners (§2011);
• The NIH strategic plan must factor disease burden into research targets (§2031);
• NIH reports are reduced to triennial events but must include multiple metrics on inter-institute collaboration (§2032, also §2042);
• Requires HHS, NIH, FDA and the U.S. Department of Agriculture to consider how to reduce grantee regulations, such as sub-recipient oversight, laboratory animal treatment and conflicts of interest (§2034);
• Establishes a shorter review pathway for some drug development tools, breakthrough devices and humanitarian devices (§3011, §3051-2); and,
• Provides for more and better-paid researchers and conference attendance for FDA and NIH scientists (§3071-3).

The Cures Act also seems to provide the NIH Director with expanded authority over funding, largely because the “High-Risk, High-Reward Research” provisions (§2036) provide the Director with authority to approve “other” funding transactions for up to all of the $1.4 billion Precision Medicine Initiative funds and 50 percent of available NIH common funds.

The current director, Dr. Francis S. Collins, was an active advocate for the Cures Act, and Republicans including the bill’s authors are calling for Dr. Collins to remain in his position during the next administration.

The bill further provides for a “Research Policy Board” for the Office of Management and Budget that will last through 2021 (§2034). This board will include not more than 10 federal representatives and 9-12 academic and nonprofit research institutions and other nonprofits. The board will provide two reports to the government reconsidering “scientific research policy, including the regulatory benefits and burdens.” The legislation makes no commitment to implement any of the board’s recommendations, which could vary greatly depending on the appointed members.

Programs

NIH, FDA and HHS are authorized to implement or continue a variety of programs through the Cures Act. Three appear to be of particular interest:

• Prize Competitions (§2002) – Authorizes a prize competition within NIH for areas of biomedical science that could improve health outcomes, particularly where there is a high potential payoff for medical breakthroughs;
• Grants for Studying Continuous Drug Manufacturing (§3016) – Allows HHS to issue grants for institutions of higher education and nonprofits to study continuous manufacturing and other innovative techniques; and,
• Transparent Reporting on Usability, Security and Functionality (§4002) – As part of an intention to improve functionality of electronic health record systems, the bill establishes grants to study systems’ effectiveness.

Additional Information

The Cures Act is a substantial piece of legislation that includes many other provisions on data sharing, mental health programs, opioid abuse prevention programs and more. Organizations with a strong interest in medical research will likely want to review provisions in more detail. The House Rules Committee has compiled a section-by-section summary and the full text is available at congress.gov.^*

^* The 21^st Century Cures Act was originally introduced and passed in the House as H.R. 6, however, the bill sent to the president was actually H.R. 34. The House used an amendment in the form of a substitute to replace H.R. 34’s text and the Senate agreed to the amendment; no standalone companion bill exists in the Senate. We are providing this note because without the background, many public statements about the Cures Act are confusing when compared against the congressional record for each bill.