Upton’s bipartisan Cures 2.0 Act draft unveiled

The United States would continue to accelerate the discovery, development and delivery of innovative 21st Century cures for a variety of diseases, according to a House discussion draft of the Cures 2.0 Act, a bipartisan bill being developed by U.S. Rep. Fred Upton (R-MI).

The draft bill that’s now circulating among lawmakers — which Rep. Upton authored with U.S. Rep. Diana DeGette (D-CO) — aligns with plans by President Joe Biden to create a new federal advanced research agency to work on cures for myriad diseases, according to the congressmen’s staffs.

“Developing and delivering new lifesaving cures is a mission that must unite all of us,” Reps. Upton and DeGette said in a joint statement released on June 22. “The Bidens know firsthand the pain and heartache that comes from losing a loved one to an illness, such as cancer. 

“Like us, they’re determined to find new cures and treatments for these difficult diseases and we couldn’t be more excited to be working with them to make this dream come true,” the members said.

For instance, included in the proposed Cures 2.0 Act is a provision that would create an Advanced Research Projects Agency for Health (ARPA-H) and authorize the more than $6.5 billion the White House says it needs to run the agency, according to a bill summary provided by the lawmakers.

The new ARPA-H would be modeled after the U.S. military’s Defense Advanced Research Projects Agency, which has successfully developed some of the nation’s most significant technological advancements, including the Internet, GPS and self-driving cars.  

And unlike other federally funded biomedical research programs, ARPA-H would be run by a small number of program managers who would have more autonomy to choose which projects to fund, thereby allowing them to pursue high-risk, high-reward projects, the summary says.

“The federal government has amazing resources at its disposal,” said Reps. Upton and DeGette. “Now is the time to put the full weight of those resources to use to cure some of the world’s most devastating diseases, such as cancer, diabetes, Alzheimer’s, and more.”

The lawmakers, who have been working with the White House for months to make the new ARPA-H a reality, included the language needed to create it in the broader Cures 2.0 Act, which they said would build upon the success they had in 2015 with passage of their comprehensive 21st Century Cures Act, according to their staffs.

While the enacted 21st Century Cures Act improved U.S. research and development of new drugs and treatments, the Cures 2.0 Act would improve how those new treatments and therapies are delivered to patients, according to the discussion draft.

In addition to creating the ARPA-H, the Cures 2.0 Act would improve how Medicare covers new healthcare technologies; increase diversity in clinical trials to ensure new drugs and treatments are safe and effective for more patients; require the Food and Drug Administration to expand the collection and use of Real World Evidence to aid in the development of new, patient-focused treatment approaches; and increase access to telehealth services for patients covered under Medicare, Medicaid, or the Children’s Health Insurance Program, among several other provisions.

The Cures 2.0 Act also would require the U.S. Secretary of the Health and Human Services (HHS) Department to conduct a nationwide study on the implications of long COVID, a condition that causes patients to experience a range of symptoms related to COVID-19 for weeks and even months after contracting the virus, according to the draft, and tasks the HHS Secretary with developing a nationwide testing and vaccine distribution strategy to be used in future pandemics.