The Fountain of Youth Revisited: Regulatory Challenges and Pathways for Healthspan Promoting Interventions
Lucille Tournas and Gary E. Marchant
For centuries, humankind has tried to evade the inevitability of aging and death by searching for the elusive fountain of youth, but the search has yielded only disappointment, false hopes, and charlatans. In the last decade or so, however, real progress has been made in the scientific understanding and modulation of the aging process. This progress has come about from a new paradigm called the “geroscience” hypothesis, which recognizes that aging is the number one risk factor for all chronic diseases. Therefore, there may be some intrinsic aging factors that can be targeted with interventions, rather than the futile attempt to extend healthy life by treating one chronic disease at a time. Utilizing genetic and other data showing that the aging process is malleable and can be slowed, scientists have recently identified key aging processes that underlie most chronic diseases and the symptoms of aging, such as frailty and cognitive decline. The next step has been to identify potential interventions that can affect or slow those aging processes, and a number of such candidate “geroprotectors” have now been identified, mostly in animal studies but in some cases in humans. The scientific progress that has been achieved in the past decade has advanced a number of promising interventions to the point where they are now ready for human clinical trials, regulatory approval and commercialization. Yet, just as the scientific advances have made significant healthspan extension a realistic possibility for the first time in human history, regulatory and legal impediments have arisen to impede the further advancement of such interventions. Specifically, because the FDA drug approval process is based on prevention and treatment of diseases, and aging is not recognized as a “disease,” there is no obvious regulatory approval pathway for therapeutics that may slow aging and extend healthspans. This paper describes this dilemma, identifies a number of alternative regulatory and commercialization pathways for healthspan extending interventions, and argues that the Food and Drug Administration (FDA) should take a more proactive role in expediting the clinical trials and regulatory approval of healthspan extension agents.
Food and Drug Law Journal
Volume 74, Number 1