Regulatory and Policy Initiatives
for Extending Human Healthspan
A key initiative of the Center for Law, Science & Innovation at ASU Law
Context: In the past few years, substantial scientific progress has been made in understanding the process of human aging and its role as the primary driver of chronic diseases such as cancer, cardiovascular disease, neurodegenerative disease, and other diseases associated with aging. A number of promising interventions have been identified (primarily in animal studies) that slow the aging process and reduce the incidence simultaneously of multiple chronic diseases. These interventions may improve human healthspan, defined as improving both the quality and length of human lifespans. However, regulatory hurdles present a major obstacle to the commercial availability of these interventions. Specifically, the Food and Drug Administration (FDA) does not recognize aging as a disease, and under its current approach will not approve a drug for anti-aging effects or for simultaneously reducing multiple chronic diseases associated with aging.
Opportunity: No other law school or other academic unit appears to be addressing the regulatory barriers for interventions to extend human healthspan, and only a few published articles have even mentioned these issues in passing. There is a major gap and opportunity for both scholarly and practical writing and ideas to identify the existing regulatory challenges and innovative proposals for overcoming those regulatory challenges. On February 26, 2016, we convened the first ever workshop in the United States on regulatory and policy issues associated with anti-aging interventions. This workshop was attended by a diverse set of experts and stakeholders with an interest in the antiaging issue, and identified a number of potential regulatory and policy initiatives to try to circumvent the existing regulatory barriers. The workshop was well-received by the participants, and there was broad recognition of the need and value of a workshop such as this on a regular basis to provide a forum for discussing the policy, regulatory, legal and ethical dimensions of healthspan extension technologies.
Moving Forward: With the success of our inaugural workshop, LSI launcheed the nation’s first project addressing the regulatory, policy, legal and ethical dimensions of human healthspan extension. This program seeks to promote valid anti-aging interventions and to reduce or overcome regulatory barriers to the commercial availability of such interventions. The program includes the following three central elements:
- An annual inter-disciplinary workshop on the Policy and Regulatory Issues in Healthspan Extension, that we hope will become established as the leading national forum for discussing and addressing the legal, regulatory, policy and ethical dimensions for healthspan extension;
- Publication of a series of papers in academic journals and the popular press on overcoming regulatory hurdles to healthspan extension interventions; and
- Pursuit of grants and other funding sources to sustain this program over the longer term.
Benefit: LSI believes that this work will help to promote and accelerate the commercial availability of effective healthspan extension interventions, thereby helping to improve the quality and length of human lives.