“An important step towards slowing aging and the onset of major age-related chronic diseases”
Washington, DC and San Francisco, CA, March 27, 2025— The Healthspan Action Coalition (HSAC) and the Kitalys Institute jointly proposed today the initial draft of a bill containing the “Therapeutic Healthspan Research, Innovation, and Validation Enhancement Act” – abbreviated as “THRIVE”. This bill, if enacted by the U.S. Congress and signed into law, would incentivize development and facilitate regulatory approval of innovative healthspan-extending products—drugs, nutritionals, devices and diagnostics. The term “healthspan” refers to the period of a person’s life spent in good health.
“As a dedicated regulatory framework for developing novel solutions that extend healthspan and reduce the debilitating burden of age-related chronic diseases,” noted Dr. Alexander Fleming, an endocrinologist and president of Kitalys Institute, “THRIVE would contribute significantly to transforming healthcare from being reactive to proactive.” As a former U.S. Food and Drug Administration official, Dr. Fleming played an instrumental role in that agency’s approval of the first statin for cardiac care and the drug metformin for metabolic care.
“At the heart of THRIVE,” Dr. Fleming continued, “we have constructed a three tier platform for product development and regulatory approval of innovative healthspan-extending products.”
Tier 1 includes products for which there is a “robust scientific basis” and “early clinical evidence”, indicating a reasonable likelihood of safely increasing healthspan in the applicable patient population. Tier 2 includes products for which there is “intermediate clinical evidence” indicating likelihood of safely increasing healthspan in the applicable patient population. Tier 3 includes products for which there is “substantial evidence” of safely increasing healthspan in the applicable patient population. Tier 3 approval is equivalent to the full approval that FDA currently grants drugs and other products. If Tier 1 and Tier 2 products do not progress to the next tier within seven years for Tier 1 and fourteen years for Tier 2, they lose their approval status.
Each of the three tiers offers a period of increasing market exclusivity –an important commercial and financial incentive for scientists in industry and not-for-profit settings, life science, biopharmaceutical and healthcare companies, and investors. Further support within THRIVE includes an FDA-led program offering guidance and clear regulatory milestones for each of the proposed three tiers. In addition, substantial cash prizes would be provided for breakthrough inventions and discoveries of healthspan products.
“The healthspan revolution is upon us,” said HSAC Executive Director Bernard Siegel, JD, a longtime advocate for regenerative medicine advanced technologies and patients for whom these technologies hold promise. “We’re facing a perfect storm of aging populations, falling birth rates, and a staggering increase in age-related conditions, Mr. Siegel continued. “This combination threatens to stress our social and medical systems as never before. We can no longer simply accept the idea that the later stages of life automatically entail declining vitality and increasing disability. Extending healthspan is not just a need, but an urgent healthcare and fiscal priority.”
“Proposing THRIVE for congressional consideration is the first step,” Dr. Fleming underscored, “toward reaching a consensus based on widespread input and discussion. To achieve that consensus, we are opening the initial draft to review and comment from all stakeholders –scientists, healthcare providers, industry, advocacy groups, and members of the public –through forums, webinars, and educational campaigns. In the coming months, HSAC and Kitalys will also co-host a series of public meetings to improve the THRIVE draft and its understanding.”
Kitalys held the first webinar on THRIVE on February 28. A recording of this online seminar can be accessed on both YouTube at [link to webinar] and the Kitalys website. Both the Kitalys and HSAC websites provide links to copies of THRIVE and related materials.”
Media Contacts:
Joseph Dawson
Director of Communications
[email protected]
Thomas Seoh
Executive Vice-President, Kitalys Institute
[email protected]
About Healthspan Action Coalition: HSAC, a not-for-profit advocacy and policy research organization, engages on multiple levels to extend the global human healthspan. It unites a broad spectrum of stakeholders in the discovery, development, and delivery of innovative medical treatments aimed at extending healthspan (i.e., the period of life spent in good health and free of debilitating disease and disability). HSAC advocates responsible policies that contribute to creating a society-wide cross-sectoral movement aimed at optimizing the application of resources and access to healthspan-oriented care and related products and services. HSAC’s leadership team and advisors include seasoned, experienced policy research professionals and scientific pioneers with proven track records of effecting major advancements in life science and healthcare. HSAC’s affiliate, The Regenerative Medicine Foundation, has organized 22 World Stem Cell Summits between 2005 and 2023.
About The Kitalys Institute: The not-for-profit Kitalys Institute was founded expressly to identify roadblocks to healthy longevity and catalyze solutions to overcome them. Kitalys organizes the annual Targeting Healthy Longevity (previously Targeting Metabesity) Conference to bring together the diversity of stakeholders necessary to tackle and solve these challenges. This widely acclaimed conference, first held in London in 2017 and subsequently in Washington DC and by streaming, has attracted leaders in NIH, FDA, the National Academy of Medicine, the US Congress and UK Parliament, geroscience, diabetes, cancer, and other chronic diseases, industry and capital markets, and consumer advocates.
