Fresh Thinking: Extending Healthy Lifespans
LIVE EVENT!
Come join us tomorrow, (Friday, February 28) at 11 a.m. ET to discuss the need for a regulatory pathway to enable the development of products that extend the span of life free of chronic diseases and disabilities
https://www.eventbrite.com/e/draft-healthspan-legislation-the-thrive-act-tickets-1246559596309
I never intended FDA Matters to focus only on the new Administration or on existential threats to FDA[1]. Nonetheless, that is mostly what you have gotten from me since we launched on January 10.
I need a break from politics. Maybe you do, too? Let’s talk instead about living longer and healthier.
This Friday (February 28) at 11 a.m. ET, I am going to be part of a web event to discuss the proposed THRIVE Act. The bill (and the event) is a first step in initiating a national discussion on how to enable the development of products that extend healthspan, the span of life free of chronic diseases and disabilities.
I applaud Kitalys Institute and the bill’s champions[2] who have raised valuable questions and developed a foresightful approach to the collective toll of chronic diseases of aging.
Those who reach their seventies are likely to live longer and in much greater numbers than ever before. Will those later years of life come at great personal and societal cost….or be the wonderful and productive years that we all wish for? Can we stimulate innovation in the discovery and marketing of drugs, vaccines, devices, OTC medicines and other products that will slow, and in some cases may completely prevent, the accumulation of chronic diseases?
Creating a pathway for such products is a cause that deserves the attention of policymakers and bold action on the part of our elected leaders. This should be a bipartisan effort, but someone needs to step up to champion it.
Secretary Kennedy, are you listening?
FDA reviews drugs, biologics, vaccines, and medical devices that treat diseases and medical conditions. A small but important segment, notably vaccines, helps prevent specific diseases[3].
The FDA is good at this. That, in turn, has stimulated an innovative biopharmaceutical and medtech environment that has made great strides in treating and preventing diseases[4].
However, looking beyond that, there is no regulatory pathway for healthspan products that addresses the goal of healthy aging and prevention of multiple chronic conditions. Such products do not fit the prevailing disease model of medicine. Plus, importantly, it is not realistic to run 20-year long trials with control groups and pre-specified endpoints.
The THRIVE Act is aimed at encouraging the development of products that prevent multiple chronic diseases and lays out a regulatory pathway that could work. I am told that discoveries from the field of geroscience, (the field that studies the biology of aging), suggest that the major chronic diseases share root causes in the aging process. Based on that insight, we can hope to find single drugs or other products that slow the aging process and delay the onset of multiple chronic diseases, including diabetes, cardiovascular, and neurodegenerative diseases.
If we want healthspan products—and want to delay and prevent chronic diseases of aging—then an appropriate and realistic regulatory pathway is needed.
Build it and inventors and investors will come!
I expect a lively discussion on Friday. Come join us for this kick-off event and the beginning of a movement to find new ways of addressing chronic diseases.
Join us for the web event at: https://www.eventbrite.com/e/draft-healthspan-legislation-the-thrive-act-tickets-1246559596309
For more background, go to https://www.linkedin.com/posts/thomasseoh_healthcare-healthspan-fda-activity-7296924407577362432-EvNq/
Please join us on Friday. Do not wait for the book and movie versions!
–Steven
I created FDA Matters to be a platform for a variety of FDA topics, such as food safety, biomedical and MedTech innovation, orphan drugs, and other policy interests of FDA and its stakeholder community.
This is an effort championed by the non-profit Kitalys Institute (www.kitalys.org) and its three co-founders: Alexander (Zan) Fleming, Founder of Kinexum and formerly FDA’s lead reviewer on a number of drugs for metabolic diseases; David Fox, a Partner at Hogan Lovells and former Associate Chief Counsel at FDA, and Thomas Seoh, CEO of Kinexum.
Prevention has largely been confined to infectious diseases. Statins, which prevent cardiovascular disease, provide one of the very few examples of a drug class that prevents chronic disease. More recently, the GLP-1 drugs have also been shown to prevent cardiovascular disease in people with diabetes or obesity. These are the exceptions, not the rule, in preventing the major causes of death and disability in our country today.
I often ask audiences: why didn’t the original Medicare (1965) include coverage for pharmaceuticals and medical devices? Sixty years ago, neither field was far enough advanced to be considered integral to disease prevention or good health. I promise future columns on how ODA, Hatch-Waxman, and other game-changers have contributed to the success of our current medical products innovation ecosystem.