A new federal research agency would seek solutions for the most challenging diseases, clinical trials would become more diverse, and patients would get new treatments sooner, under proposed legislation that was described in detail last week by members of Congress.
Cures 2.0—the long-awaited update to the 21st Century Cures Act—was the topic of discussion during a virtual congressional briefing with U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO), hosted by MichBio on Wednesday.
Here’s what you need to know about Cures 2.0 and how it would make new treatments more accessible to patients.
Background: The 21st Century Cures Act of 2016
“When we first started working on this legislation, the mission was to simply advance medical research and foster a new era of medical innovations and to try to find cures that will help us with some of the world’s most difficult and intractable diseases,” said Rep. DeGette.
“And so eventually, what we wanted to do was cut barriers that hold up clinical trials and also to expedite approval of new drugs and devices. This effort eventually led to the passage of the 21st Century Cures Act in 2016,” she continued.
And indeed, the legislation could not have come at a better time: “We would have lost hundreds of thousands more Americans [to COVID-19] had we not gotten the 21st Century Cures Act done because that really did set the stage to expedite the approvals of drugs and devices,” said Rep. Upton. The legislation helped expedite developing and administering COVID-19 vaccines eight or ten months earlier than they otherwise would have been developed.
“Without this legislation, we would have been up the creek without a paddle for a much longer time,” said Rep. Upton.
Now, Reps. Upton and DeGette are working to build on that success.
“21st Century Cures really focused on revolutionizing how we research and develop new cures and treatments,” said Rep. DeGette. “2.0 is looking at how we modernize how we get these breakthrough treatments and drugs to patients faster.”
What is Cures 2.0?
Introduced in November of 2021, the bipartisan Cures 2.0 legislation “addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research.”
The bill creates an entirely new agency aimed at ending some of the world’s most difficult diseases. According to Rep. DeGette’s office, “The so-called Advanced Research Projects Agency for Health, or ARPA-H, would be housed within the National Institutes of Health and tasked with finding new cures and treatments to a slate of illnesses that affect tens of millions of Americans across the country.”
Cures 2.0 would also seek to increase diversity in clinical trials by:
- Requiring an update from FDA on efforts to improve diversity in clinical trials;
- Requiring a GAO study on barriers to clinical trial participation;
- Requiring the Department of HHS to conduct a public awareness campaign to increase awareness and understanding, particularly in minority communities, of clinical trials; and
- Establishing a task force to make clinicaltrials.gov more user- and patient-friendly.
Additional provisions include:
- Transforming how Medicare covers innovative new treatments and technologies to make those new discoveries available to patients sooner.
- Increasing access to telehealth services for Medicare and Medicaid patients, including those covered under the Children’s Health Insurance Program (CHIP).
- Training and educational programs for at-home caregivers, including family members with no prior health care experience.
- Providing patients with more information about treatment options available to them to make them a more integral part of the decision-making process.
Read a section-by-section summary of Cures 2.0.
“Cures 2.0 could help ensure scientists, researchers and entrepreneurs have the policy and regulatory environment they need to develop new medicines for patients around the globe,” said BIO President and CEO Dr. Michelle McMurry-Heath in November 2021, when Cures 2.0 was introduced.
‘Frankly, patients can’t wait.’
Perhaps what’s most interesting about the 21st Century Cures Act and Cures 2.0 is that both highlight how bipartisanship is still possible in a partisan political environment.
“We had so many ideas and they were all bipartisan,” said Rep. Upton. “When that bill passed, everybody was on board and it was a 53-to-nothing vote.
“We want to duplicate that same thing,” he continued. “So, let’s not be behind. Let’s get this done. Frankly, patients can’t wait.”
