21st Century Cures Act, P.L. 114-255
On December 13, 2016, President Obama signed the 21st Century Cures Act into law. The nearly 1,000-page bill passed the House 392-26 and the Senate by a vote of 94-5. The act has been praised as an example of bipartisan support and seeks to increase funding for biomedical research, enhance the speed at which drugs are developed and approved, provide funding for a response to the opioid abuse crisis, and support mental health care. Key provisions for NIH aim to coordinate policies relating to early career investigators, improve loan repayment programs, and streamline procedural requirements for attendance at scientific meetings. The bill reauthorizes the NIH for FY18-FY20 at the following levels:
- $34,851,000,000 for FY 2018
- $35,585,871,000 for FY 2019
- $36,472,442,775 for FY 2020
In addition, the bill creates a $4.8 billion "NIH Innovation Account." The funds in the Innovation Account support these specific projects:
- Precision Medicine Initiative -- $1.45 billion over the next 10 years
- Beau Biden Cancer Moonshot -- $1.8 billion over the next seven years
- BRAIN Initiative -- $1.511 million over the next 10 years
- Regenerative Medicines -- $30 million over the next four years
Beau Biden Cancer Moonshot
One of the key features of the NIH Innovation Account is the Beau Biden Cancer Moonshot. This provision of the bill was renamed via a joint amendment introduced by Senate Majority Leader Mitch McConnell (R-KY) and Senate Minority Leader Harry Reid (D-NV), in honor of Vice President Joe Biden's son Beau, who passed away from cancer in 2015. The $1.8 billion for the Cancer Moonshot was authorized to be appropriated as follows:
- $300 million for FY 2017
- $300 million for FY 2018
- $400 million for FY 2019
- $195 million for FY 2020
- $195 million for FY 2021
- $194 million for FY 2022
- $216 million for FY 2023
The bill describes the purpose of the Cancer Moonshot funding as follows: To support cancer research, such as the development of cancer vaccines, the development of more sensitive diagnostic tests for cancer, immunotherapy and the development of combination therapies, and research that has the potential to transform the scientific field, that has inherently higher risk, and that seeks to address major challenges related to cancer.
- Encourages the FDA to approve new drug based on real-world evidence and surrogate endpoints, such as biomarkers.
- Calls for the use of data summaries to support the approval of certain drugs for off-label use.
- Allows for a quicker path for breakthrough medical technologies for patients with life-threatening or irreversibly debilitating diseases.
Sens. Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) led the opposition to the Cures Act. They argued that the FDA provisions watered down safety requirements for new drugs and devices, and potentially, compromise patient safety. Rep. Rosa DeLauro (D-CT) also opposed the bill, citing similar concerns about FDA provisions. She was one of only seven democrats in the House who voted against the bill's passage. Rep. Barbara Lee (D-CA), who serves alongside Rep. DeLauro on the House Labor-HHS Appropriations Subcommittee, was also a no vote.
Changes to Leadership and Committee/Subcommittee Membership
Changes to Senate and House Leadership for the 115th Congress are minimal, with Sen. Chuck Schumer (D-NY) replacing Sen. Harry Reid (D-NV, retired) as Senate Minority Leader. Sen. Mitch McConnell (R-KY) remains Senate Majority Leader. Rep. Paul Ryan (R-WI) remains Speaker of the House, and Rep. Kevin McCarthy (R-CA) and Nancy Pelosi (D-CA) remain House Majority and Minority Leader, respectively.
House Appropriations Committee
Rep. Rodney Frelinghuysen (R-NJ) was named the new chair of the full committee. Rep. Nita Lowey (D-NY) remains ranking member of the full committee, Rep. Tom Cole (R-OK) remains the chair of the L-HHS subcommittee, and Rep. Rosa DeLauro (D-CT) will continue to serve as ranking member of the L-HHS subcommittee. New members of the L-HHS subcommittee are Rep. Jaime Herrera Beutler (R-WA), Katherine Clark (D-MA), John Moolenaar (R-MI), and Mark Pocan (D-WI).
Senate Appropriations Committee
Sen. Thad Cochran (R-MS) remains chair of the full committee, and Sen. Patrick Leahy (D-VT) is serving as the ranking member of the full committee, replacing Sen. Barbara Mikulski (D-MD, retired). Sen. Roy Blunt (R-MO) and Patty Murray (D-WA) remain the chair and ranking member, respectively, of the L-HHS subcommittee. New members of the L-HHS subcommittee are Sens. John Kennedy (R-LA), Joe Manchin (D-WV), Chris Murphy (D-CT), and Marco Rubio (R-FL).
House Energy and Commerce Committee
The majority leadership of both the full committee and health subcommittee has changed hands; Rep. Greg Walden (R-OR) is the new full committee chair, and Dr. Michael Burgess (R-TX) has taken on leadership of the health subcommittee. Rep. Frank Pallone (D-NJ) remains ranking member of the full committee and will serve as an Ex Officio member of the subcommittee, and Rep. Gene Green (D-TX) continues to serve as ranking member of the subcommittee. New members of the health subcommittee are Reps. Susan Brooks (R-IN), Buddy Carter (R-GA), Diana DeGette (D-CO), Anna Eshoo (D-CA), Richard Hudson (R-NC), and Markwayne Mullin (R-OK). Rep. Fred Upton (R-MI), former full committee chair, is also a new member of the subcommittee, and Rep. Greg Walden (R-OR) will serve as an Ex Officio member.
Senate Health, Education, Labor and Pensions (HELP) Committee
Leadership of the HELP Committee remains the same, with Lamar Alexander (R-TN) serving as chair and Patty Murray (D-WA) serving as ranking member. New members are Sens. Todd Young (R-IN), Tim Kaine (D-VA), and Maggie Hassan (D-NH).