House Approves Drug Pricing Bill with NIH, FDA, and Opioids Funding
On December 12, the House passed along party lines (230-192) H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. Although the bill focuses primarily on drug pricing and coverage for dental, vision, and hearing, last week House leadership added provisions (Title VII) that relate to the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Opioid Epidemic Response. The NIH section incorporates language from H.R. 4667, the Biomedical Expansion Act of 2019, sponsored by Cong. Mikie Sherrill (D-NJ) and the FDA section incorporates language from H.R. 4663, the Investing in Safety and Innovation Act, sponsored by Congs. Anna Eshoo (D-CA) and Scott Peters (D-CA). Those bills proposed to amend the 21st Century Cures Act to reauthorize funding for the NIH Innovation Fund projects and the FDA Innovation Account projects, respectively.
For the NIH, H.R. 3 appropriates supplemental funding to the amount provided under the 21st Century Cutes Act for the NIH Innovation Fund. For the total amount authorized for Fiscal Years (FY) 2021 through FY2030, the funding would be allocated as follows:
- $2.07 billion for the Precision Medicine Initiative;
- $2.04 billion for the Brain Research through Advancing Innovative Technologies (BRAIN) Initiative;
- $1.56 billion for the Cancer Moonshot;
- $154 million for the Regenerative Medicine Initiative (using adult stem cells);
- $1.14 billion for Antimicrobial Resistance (AMR) research; and
- $53.6 million for Rare Diseases research.
In summary, the legislation extends the Innovation Fund from FY2026 to FY2030, “smooths out” the variations in funding from year-to-year within the first four initiatives above that were specified in the 21st Century Cures Act, and adds funding for AMR and Rare Diseases to the Innovation Fund. It also establishes within NIH a Clinical Trial Acceleration Pilot Initiative, funded at $500 million for each of fiscal years 2021-2025.
The FDA would receive an additional $2 billion for various Innovation Account projects, and the bill would establish an Opioid Epidemic Response Fund, providing $1.98 billion annually for fiscal years 2021-2025. H.R. 3 would fund all of these programs directly through savings, therefore bypassing the annual appropriations process.
The inclusion of the reauthorization and expansion of NIH and FDA Innovation activities in H.R. 3 sets a marker, even though the Senate is unlikely to take up the full bill for consideration, preferring its own bill [S. 1227, the Prescription Pricing for the People Act of 2019, introduced by Senator Chuck Grassley (R-IA)] that focuses on drug pricing. These NIH and FDA provisions could change in future legislation, as the House Energy and Commerce Committee has initiated its own Cures 2.0 legislative process.
NAEVR will continue to monitor all legislative developments related to Cures reauthorization, as vision researchers have received funding from both the BRAIN and Regenerative Medicine Initiatives.