Will the 21st Century Cures Act Deliver Innovation and Health Breakthroughs for Post-Infection Diseases?

By Emily Taylor, Director of Advocacy and Community Relations

Five years ago, the 21st Century Cures Act (Cures Act) was signed into law making national headlines, launching new health initiatives, and spearheading a new chapter in government scientific investment. With robust funding, multiple government agencies rolled out programs designed to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

And yet, America’s biomedical and research and development (R&D) sectors did not gain the anticipated edge against international competitors and millions of patients still fell through the cracks. Did the 21st Century Cures Act go wrong? No. Big problems require big solutions. It simply didn’t go far or big enough.

This year, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures Act 2.0 discussion draft. This much-anticipated follow-up is already on track to deliver a very different vision for America’s biomedical investments. According to a press release from the office of Rep. DeGette, “While 21st Century Cures focused on the discovery of new cures, the second iteration of landmark legislation will explore ways to safely and efficiently modernize the delivery of treatments to patients.”


And what’s really hope-inspiring is the way those treatments are delivered. Science-forward and evidence-based, the massive legislative package acknowledges the gaps and makes appropriate considerations. For example, the first section, “Further Understanding the Implications of Long COVID,” delivers the desperately overdue federal leadership regarding the gaps in healthcare coverage for millions of COVID-19 long haulers who have fallen through the cracks of our traditional healthcare and safety net systems.

Next, the proposed Long Covid learning collaborative will fill another crucial void; diagnostics and therapeutics for Long Covid. While the National Institutes of Health’s (NIH) $1.15 billion RECOVER Initiative has begun the quest in “basic science,” the real need is for patients to GET IDENTIFIED and GET WELL. Our nation cannot afford to sacrifice an estimated 3.2 million people to lifelong chronic illness. Upton and DeGette’s proposal is the first major congressional step to address this public health crisis since Representatives Beyer and Bergman’s COVID-19 Long Haulers Act.

Another innovation is quietly peppered in multiple places throughout the bill, and offers big hopes for post-infection illness patients. Three words. PATIENT. EXPERIENCE. DATA. It seems simple, but this will revolutionize the research landscape for anyone who’s ever been told by their doctor, “I can’t find anything wrong with you” when they know that simply isn’t the case. In a systematic commitment, the Cures 2.0 Act finally enables federal agencies to utilize information drawn from patient experience, real-world evidence, and finally embrace patient-reported outcomes. While not every agency will evolve right away, Cures 2.0 sets into motion the critical first steps towards a revolutionary transformation in research: a world where a patient voice is central.

The act would also create ARPA-H, Advanced Research Projects Agency for Health. This new agency’s mission would be “to speed transformational innovation in health research and speed application and implementation of health breakthroughs…” by funding projects that could:

  • Tackle bold challenges requiring large scale sustained coordination;
  • Create new capabilities (e.g., technologies, data resources, disease models);
  • Support high-risk exploration that could establish entirely new paradigms; and/or
  • Overcome market failures through critical solutions, including financial incentives;
  • Complement NIH’s existing research portfolio and mission and the private sector’s research initiatives

Dr. Francis Collins, Director of the NIH, wrote about ARPA-H’s potential in ARPA-H: Accelerating biomedical breakthroughs. We’re enthusiastic about the capability of this initiative to tackle the big challenges, and we’re ready to fight for post-infection disease to be one of the inaugural projects if ARPA-H is implemented next year.

Congress must fully fund ARPA-H before we can fully imagine its potential, but one thing is clear: It’s about time! ARPA-H’s older cousin, the Defense Advanced Research Projects Agency (DARPA) birthed such wonders as GPS, Siri, and the Internet. We must invest in the health of citizens with the same high-risk, high-reward enthusiasm that we bring to our defense technology.

Those concerned with post-infection diseases should especially pay attention to ARPA-H. One of the biggest challenges in funding treatment trials and hypothesis-generating research (exactly what is needed!) is that NIH doesn’t fund it. So, if NIH doesn’t fund the kind of work you need, who do you turn to for government funding? ARPA-H could be the answer: a research home for the public health projects left behind, deemed not profitable enough by investors.

While all of this is exciting, the biggest impact is yet to come! Nothing can beat cold hard cash in the race for research, and Cures 2.0 delivers where its predecessor fell short. The final provision of the bill, known as “Research Investment to Spark the Economy” or the RISE Act, allocates $25 billion to independent research institutions, public laboratories, and universities throughout the country. Not only does this investment combat the COVID-19 disruption to our R&D, but also kickstarts America’s competitive edge internationally, where many believe we’re falling behind.

There are many exciting reasons to be optimistic about the future of America’s biomedical infrastructure, but only if we give it the vision it deserves, and avoid repeating our past mistakes. Cures 2.0 could be the way to a better, healthier, future.