Federal Priorities

FEDERAL PRIORITIES

For the first time in history, it appears aging is not an inevitable fate to which every human is consigned. Recent scientific advances demonstrate that the underlying causes of aging can be treated to prevent age-related diseases, ensuring Americans live longer, healthier lives. Supporting this kind of medicine is not only a moral imperative – it’s a fiscally and politically sound investment. So, what actions can the government take to advance the field? A4LI has identified five actions Congress can take:

1. Increase allocations to the National Institute of Aging – Division of Aging Biology;

2. Make geroscience and longevity medicine a focus of ARPA-H;

3. Create a dedicated regulatory pathway for longevity medicines;

4. Fund Congressional Budget Office research into the longevity dividend;

5. Initiate a national movement to increase healthy lifespan by setting an actionable, time-bound goal.


1. Increase allocations to the National Institute of Aging – Division of Aging Biology

If we can reorient our economy to focus on people living healthier for longer, the economic gains will be unparalleled.

Aging research in the United States is severely underfunded. Just 0.6% of the budget for the National Institutes of Health – $350 million of the nearly $52 billion budget – is spent on research into aging biology. In comparison, cancer receives $6.1 billion in research funding; COVID-19 receives $4.9 billion; and heart disease receives $2.6 billion. Even the National Institute of Aging within the NIH spends just 10 percent of its budget on the biology of aging. Most of its funding is spent on neuroscience – in particular, research into Alzheimer’s disease and dementia.

Increasing funding for aging biology research is vital, because aging is the leading risk factor for each of these diseases. Take cancer, for example. President Biden recently announced that the White House will reinvigorate Cancer Moonshot: reduce the death rate from cancer by at least 50 percent over the next 25 years, and improve the experience of people living with cancer. Funding aging research may be the most effective way to achieve these goals. Consider that, while smoking increases your risk for cancer by a factor of 15, aging increases it by 100. Any comprehensive research into cancer prevention will require a better understanding of the aging biology underlying this risk factor.

Furthermore, funding this research will not only develop strategies for cancer prevention. The same research will create in-roads for preventing other age-related diseases including diabetes, heart disease, and Alzheimer’s disease. That’s why every dollar spent on aging biology research is like spending a dollar for research on every single age-related disease. Given the benefits that such research will have on health outcomes for a wide variety of diseases, it is vital that the U.S. prioritizes funding for this field. A4LI calls for Congress to double the budget of the National Institute of Aging – Division of Aging Biology to $1 billion by 2025.


2. Make geroscience and longevity medicine a focus of ARPA-H

To accelerate research that can improve Americans’ health, President Biden is proposing the establishment of the Advanced Research Projects Agency for Health (ARPA-H). Included in the President’s FY2022 budget as a component of the NIH with a requested funding level of $6.5B available for three years, ARPA-H will be tasked with developing high-risk, high-reward technologies to drive biomedical breakthroughs – ranging from molecular to societal – that would provide our nation’s patients with transformative solutions. The program is modeled after the extremely successful Defense Advanced Research Projects Agency (DARPA), which is responsible for technological advancements such as the computer mouse and “packet switching” – the foundation for today's internet. ARPA-H would help to fund bold ideas that slip through current cracks in research and development because:

            • the risk is too high;
            • the cost is too large;
            • the time frame is too long;
            • the focus is too applied for academia;
            • there is a need for complex coordination among multiple parties;
            • the near-term market opportunity is too small to justify commercial investment; and/or
            • the scope is so broad that no company can capture the economic benefit.

Research into longevity therapies meets several of these qualifiers. Drug development is always commercially risky. However, it is especially risky when exploring a new class of medicines predicated on novel underlying biology. Designing clinical trials to test interventions that target the aging process poses a unique set of challenges – for example, testing the effect on longevity itself may not be feasible in the time frame of a typical clinical trial – which can further increase costs and risks. Because of these aspects of aging research, it is particularly suited for ARPA-H.

A key factor in DARPA’s success is the role of program managers. They work with R&D stakeholders to establish rigorous, aggressive program goals (including detailed technical milestones) needed to manage a portfolio of sophisticated R&D projects. For ARPA-H to succeed in its mission, program managers must have an understanding of the geroscience approach and the potential impact longevity medicine will have on society.

Like DARPA, ARPA-H should be solely focused on making pivotal investments in next-generation, breakthrough medical technologies. Geroscience has the ability to simultaneously treat many of the diseases Americans face in later life, and should be given high priority as ARPA-H is established. Given these parameters, A4LI supports the establishment and appropriate funding of ARPA-H, and urges policymakers to make geroscience a priority as the program moves forward.


3. Create a dedicated regulatory pathway for longevity medicines

In 2016, Congress passed the 21st Century Cures Act, intended to accelerate medical product development and commercialization. The Cures Act established a new expedited product development program, the Regenerative Medicine Advanced Therapy (RMAT) Designation. This designation, intended to expedite the approval of cell, gene, and tissue-based products, can be granted for products that are intended to treat a serious disease and have shown preliminary clinical evidence indicating the drug has the potential to address unmet medical needs. Benefits of the designation include increased FDA interaction and eligibility to apply for priority review for approval of the new therapy.  To date, therapies have received the FDA’s RMAT Designation, and three have been approved: one therapy to treat a rare, fatal birth defect, one therapy to treat a serious form of lymphoma, and one therapy to treat severe burns.Other therapies that have received the designation target sickle cell disease, fatal genetic disorders, and cancers that no longer respond to chemotherapy. While there are other FDA Designations that are technology agnostic – the Breakthrough and Fast Track Designations – the RMAT Designation has some advantages over those pathways. For example, while the benefits of the Breakthrough Designation and RMAT Designation are very similar, the RMAT Designation has slightly less strenuous requirements for receiving the designation.

This allows the FDA to better incentivize development for this novel class of therapeutics. The RMAT Designation has catapulted regenerative medicine into the mainstream. A Longevity Medicine (LM) Designation could do the same for longevity therapies. While some aging therapies fall under the category of regenerative medicines, some would not. They will need to meet the stricter requirements of a Breakthrough Designation. Additionally, because aging is not currently recognized as a disease by the FDA, and because many of these therapies would be
preventative in nature, it is possible that they may not qualify as intending to treat, modify, or reverse a serious or life-threatening disease or condition. Instead, sponsors would need to resort to showing that the therapy could treat one specific age-related disease, and then conduct additional trials to expand into other indications.

A4LI calls for the creation of a specialized Longevity Medicine Designation that could be tailored to reflect the unique potential of this class of therapies. This designation could help to create regulatory clarity for aging therapies and accelerate their development.


4. Fund Congressional Budget Office Research into the Longevity Dividend

By addressing the underlying causes of age-related disease, the United States could see significant financial returns. The government pays for more than 65% of healthcare costs for the elderly through Medicare and Medicaid spending. Age-related diseases pose the most significant financial burden on the American healthcare system. For example, Alzheimer’s and other forms of dementia cost the U.S. $305 billion in 2020, with Medicare and Medicaid paying for roughly $206 billion of those costs. And with the average age of the American population increasing, those expenses are expected to nearly triple by 2050.Besides offsetting the direct cost of treating age-related diseases, this field will provide significant indirect financial benefits. The savings will be further amplified when the U.S. reinvests these hundreds of billions of dollars. Additionally, Older adults could work longer, improving their total economic output. Moreover, an increase in average healthspan would mean older adults participate as consumers – traveling, buying groceries, seeing movies – for longer. As described previously, these economic benefits add up to what is known as the longevity dividend. Economists have previously evaluated the value of increasing the healthy human lifespan; estimates range from $7.1 billion in returns for increasing the average healthy human lifespan by 2.2 years to $38 million for just one additional year of healthy life. It is clear that developing aging therapies has financial benefits, but the exact return depends on many factors. There is a need for objective, nonpartisan, and timely analysis of the longevity dividend to inform Congressional actions in this field of science. With many voters and politicians increasingly concerned with the national debt, it is imperative that the United States is able to fully realize the financial benefits of longevity therapies. The Congressional Budget Office is uniquely positioned to provide this analysis. A4LI urges Congress to ask that the CBO conduct research to determine the potential impact of the longevity dividend in the U.S.


5. Initiate a National Movement to Increase Lifespan and Healthy Lifespan

In 2017, the United Kingdom released a white paper identifying four ‘grand challenges’ designed to tackle significant issues the country is facing. One of those was a grand challenge on aging, championed by the country’s All-Party Parliamentary Group on Longevity. Like many other countries, people over 65 are a rapidly growing proportion of the population – potentially leading to lower tax revenue as retirees exit the workforce and an increased strain on national resources. In 2018, the UK set a new goal to propel this ‘grand challenge on aging’ forward: to add five
years to healthy life expectancy by 2035. To help reach this goal, the UK has announced £130 million of investment to support healthcare innovation, including £69.5 million towards new treatments that allow people to lead healthier and longer lives. The UK is not the first major government to take this approach to extending life expectancy: in 2008, the European Union announced a goal to increase average life expectancy by two years by 2020, a goal they achieved. This approach has been utilized for other initiatives, including health-related initiatives, in the United States: President Biden’s recent Cancer Moonshot aims to cut today’s age-adjusted death rate from cancer by at least 50 percent over the next 25 years.The Department of Health and Human Services’ Healthy People program, first established in 1979, outlines clear, measurable goals as a part of a ten-year plan to improve health outcomes in the U.S. These are examples of public longevity goals that are strategic, measurable, attainable, results-oriented, and time-bound (SMART), often used in government and industry. Publicizing them encourages follow through. To increase the average American’s healthspan, policymakers should outline clear, actionable goals that can be supported by both the legislative and executive branches. As such, A4LI encourages Congress to initiate a national movement to increase healthspan by adopting a goal to increase the average American’s healthspan by five years by 2030.


Conclusion

The longevity field has reached a critical moment. We are developing therapies targeting the underlying causes of aging to treat and prevent diabetes, Alzheimer’s, cancer, and age-related loss in muscle and immune function. These therapies have the potential to radically improve health outcomes for older people in the United States, ensuring they live longer, healthier lives. They have the potential to help Americans subsist independently in their older years. In addition to the moral imperative the U.S. government has to support medicines that will transform their citizens’ lives, aging therapies are a sound financial and political investment. Our nation can look forward to reduced healthcare costs and greater economic growth as more citizens participate in the economy for longer. These benefits have the potential not only to offset, but also exceed the therapies’ development costs. Additionally, the United States stands to establish a significant competitive advantage over other countries by investing early into longevity therapies. By becoming a leader in the longevity space, the United States can increase its economic output, improve the average experience level of U.S. workers, and improve the health of U.S. servicemen and women. To fully realize and accelerate the accruement of these benefits, Congress must take action to pave the way for the development of longevity therapies. There is broad bipartisan support for longevity research. As such, policymakers should take this opportunity to represent the interest of all Americans by enacting legislation to advance this transformative new form of medicine. Create a specialized regulatory pathway for longevity medicines. Support Congressional Budget Office research into the longevity dividend. Set actionable, time-bound goals to launch a national movement to increase Americans’ healthspan. A4LI looks forward to working with policymakers to advance this innovative field and create social and political action around the issues of combating age-related chronic conditions and increasing Americans’ number of healthy, disease-free years.