Sign On to Support the Multi-Disease Therapeutic Designation
Members of Congress and Federal Health Policymakers
Full proposal here
The Food and Drug Administration (FDA) has built an expedited drug development framework that has transformed how innovative therapies reach patients. Programs such as Breakthrough Therapy Designation, Fast Track, Accelerated Approval, Priority Review, and the Regenerative Medicine Advanced Therapy (RMAT) designation have shortened development timelines and accelerated the delivery of treatments for cancer, rare diseases, and other serious conditions.
However, these pathways were designed around a traditional model: one drug, one disease.
That framework is increasingly mismatched with a new class of investigational therapies designed to target the biological mechanisms that contribute to multiple chronic diseases of aging. Today, sponsors developing these therapies must navigate separate FDA review divisions for each disease indication, often facing inconsistent endpoint requirements and duplicative clinical trial expectations. The result is unnecessary delay, increased development costs, and reduced investment in therapies that could address several age-related diseases simultaneously.
A4LI's white paper proposes the creation of a Multi-Disease Therapeutic Designation (MDTD): a new expedited designation under 21 U.S.C. §356 modeled after successful pathways such as RMAT and the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).
Under this proposal, an investigational therapy would qualify for MDTD if it is intended to address biological mechanisms common to two or more serious age-related chronic diseases and preliminary clinical evidence suggests the potential to address unmet medical needs.
The Proposal:
Requires no new appropriations and creates no new FDA office or program.
Does not lower FDA's safety or efficacy standards.
Establishes a dedicated expedited pathway for therapies that target multiple age-related diseases through shared biological mechanisms.
Builds on clear congressional precedent, including the creation of Breakthrough Therapy Designation through FDASIA (2012) and RMAT and LPAD through the 21st Century Cures Act (2016).
The upcoming PDUFA VIII reauthorization, covering FDA fiscal years 2028–2032, presents a natural legislative vehicle for this reform.
Chronic diseases account for approximately 90 percent of the nation's $4.9 trillion in annual healthcare expenditures, and nearly half of Medicare beneficiaries live with four or more chronic conditions. Creating a regulatory pathway specifically designed for therapies that address the shared biology underlying these diseases represents one of the most impactful and cost-effective reforms available to Congress during the upcoming reauthorization cycle.
Sponsored by
To:
Members of Congress and Federal Health Policymakers
From:
[Your Name]
To my Elected Officials,
I am writing as a constituent and supporter of the Alliance for Longevity Initiatives (A4LI) to urge your support for policies that modernize the development, testing, and evaluation of medical devices.
The United States has long been a global leader in medical innovation, yet many of the systems used to evaluate emerging technologies were designed for a different era. Advances in artificial intelligence, digital health, advanced diagnostics, and next-generation medical devices have created unprecedented opportunities to improve patient outcomes and accelerate medical progress. However, outdated development and testing frameworks can unnecessarily delay patient access to promising innovations.
A4LI's Modernizing Device Testing and Development (MDTD) proposal outlines practical reforms that would enable regulators, researchers, and innovators to leverage modern scientific tools while maintaining strong standards for patient safety. These reforms include expanding the use of real-world evidence, encouraging advanced computational approaches, improving evidence generation pathways, and creating more efficient mechanisms for evaluating novel technologies.
Modernizing device testing and development would help patients access innovative treatments more quickly, strengthen American competitiveness in biomedical innovation, reduce healthcare costs, and accelerate the development of technologies that improve health and longevity.
I respectfully urge you to review A4LI's MDTD proposal and support efforts to modernize the nation's medical device development ecosystem. By embracing evidence-based regulatory modernization, Congress and federal agencies can help ensure that patients benefit from the full potential of twenty-first century medical innovation.
Thank you for your time and service.