Washington, D.C., December 29, 2022 – The Alzheimer’s Association and the Alzheimer’s Impact Movement (AIM) commend the passage of the fiscal year 23 (FY23) budget, which was signed into law today and included critical bipartisan policy priorities to address Alzheimer’s and dementia across the nation. This legislation included key provisions of the bipartisan Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act (S. 1548 / H.R. 3085), language to strengthen the Food and Drug Administration’s (FDA) accelerated approval pathway, a $226 million increase for Alzheimer’s and dementia research funding at the National Institutes of Health (NIH), and $33 million to implement the BOLD Infrastructure for Alzheimer’s Act (P.L. 115-406).
“The Alzheimer’s Association and AIM commend bipartisan congressional champions for their continued commitment to those impacted by Alzheimer’s and all other dementia,” said Robert Egge, AIM executive director and Alzheimer’s Association chief public policy officer. “Today we saw our nation take a significant step forward to increase the participation of underrepresented populations in Alzheimer’s and other dementia clinical trials, strengthen the accelerated approval pathway to ensure more people can gain earlier access to new and innovative treatments, and ensure a robust Alzheimer’s and dementia research budget at the NIH and critical investment in the Alzheimer’s public health response. On behalf of the Alzheimer’s community, thank you to our advocates and our congressional champions for their tireless efforts.”
Advancing Equity in Alzheimer’s Clinical Trials
To ensure future treatments and means of prevention are effective in all populations, Alzheimer’s and other dementia research must be reflective of all Americans. The ENACT Act, introduced by Representatives Lisa Blunt Rochester (D-Del.), Jaime Herrera Beutler (R-Wash.), John Curtis (R-Utah), Christopher Smith (R-N.J.) and Maxine Waters (D-Calif.) and Senators Ben Ray Luján (D-N.M.) and Susan Collins (R-Maine), seeks to advance equity in Alzheimer’s clinical trials.
The key provisions of the ENACT Act included in this legislation will advance this goal by expanding education and outreach to these populations, encouraging the diversity of clinical trial staff and reducing the burden of participation.
Thanks to bipartisan congressional champions and dedicated advocates, our nation has taken action to address health disparities in Alzheimer’s and dementia research.
Strengthening the Accelerated Approval Pathway
Lives have been saved, extended and improved because of the use of the accelerated approval pathway. Through the pathway, people living with an unmet medical need — like Alzheimer’s and other dementia — can gain earlier access to new and innovative treatments.
By including critical elements first introduced in the bipartisan Modernizing Accelerated Approval Act by Senators Susan Collins (R-Maine) and Tim Kaine (D-Va.), this critical tool will be preserved and strengthened. The FDA will better utilize the accelerated approval pathway, set benchmarks for accelerated approval development plans and strengthen transparency throughout the process.
AIM was proud to work with bipartisan congressional champions and other voluntary health care groups to strengthen the FDA’s accelerated approval pathway.
Investing in Research and BOLD Infrastructure for Alzheimer’s Act
Thanks to the leadership of longtime congressional champions, including Sen. Roy Blunt (R-Mo.), Sen. Patty Murray (D-Wash.), Rep. Rosa DeLauro (D-Conn.) and Rep. Tom Cole (R-Okla.), a sustained investment in Alzheimer’s and dementia research continues into FY23. The legislation includes a $226 million increase for Alzheimer’s and dementia research funding at the NIH.
The omnibus bill also includes $33 million to implement the BOLD Infrastructure for Alzheimer’s Act (P.L. 115-406). The BOLD Infrastructure for Alzheimer’s Act directs the Centers for Disease Control and Prevention (CDC) to strengthen the public health infrastructure across the country by implementing effective Alzheimer’s interventions focused on public health issues such as increasing early detection and diagnosis, reducing risk and preventing avoidable hospitalizations. It also establishes Alzheimer’s and Related Dementia Public Health Centers of Excellence, providing funding to state, local and tribal public health departments and increasing data analysis and timely reporting.