Reps. Upton, DeGette reveal sequel to 'Cures' biomedical innovation, research bill
Washington — Republican U.S. Rep. Fred Upton on Tuesday introduced his long-expected biomedical research bill, following up on the landmark 2016 legislation aimed at expediting cutting-edge medical treatments, therapies and devices.
The bill, designed as a sequel to the 21st Century Cures Act, is dubbed Cures 2.0 and is again written with Democratic Rep. Diana DeGette of Colorado. Upton is former chairman of the House Energy and Commerce Committee.
He and DeGette told reporters Tuesday that they hope to "fast track" the bill to pass it in early 2022 at the latest, saying it's critical for accelerating the delivery of medical innovations and treatment to patients that need it.
Upton has noted that the federal government wouldn't have been able to grant emergency use approval to produce the COVID-19 vaccines if he and DeGette hadn't have passed their Cures legislation in 2016.
"While 21st Century Cures focused on finding new cures and treatments for some of the most difficult diseases, Cures 2.0 is going to focus on helping us get those cures and treatments to patients more quickly," DeGette said.
The legislation would authorize $6.5 billion to create and fund the first three years of a new federal agency housed within the National Institutes of Health. The department would be an incubator of sorts tasked with building platforms to support a high-risk approach to disease research and discovery, modeled after the success of the Pentagon's U.S. Defense Advanced Research Projects Agency.
The U.S. House already appropriated $3 billion for this new agency, the Advanced Research Projects Agency for Health, or ARPA-H, Upton noted.
"This is an exciting new provision that's going to be funded well into the future to really provide for the breakthrough therapies and cures that we all want to see," he said.
The lawmakers said the bill also would overhaul how Medicare pays for new treatments and technologies and increase access to telehealth services for Medicare and Medicaid patients, including those covered by the Children's Health Insurance Program (CHIP).
The bill would provide training and education to home-based caregivers, including family members, and would boost diversity in clinical trials to ensure new drugs and treatments are safe and effective for a more representative population, the lawmakers said.
Upton and DeGette have worked on the legislation for about two years. They had originally intended to introduce it last spring and pass it by year's end, but delays with the legislative counsel forced them to wait, Upton said.
They acknowledged that other must-pass legislation such as government funding and raising the debt ceiling will crowd the schedule in Congress for much of December, and that their bill might not get through by year's end.
"At the end of the day, we're now going to try to put this on the fast track and work with our Senate colleagues," Upton said.
"But we may not meet the deadline before the end of the calendar year, unless we really put in some long nights — which somehow I think we're gonna be doing even without this bill."
DeGette predicted the bill wouldn't be as difficult to get through the Congress as the original Cures package.
"One good thing about where we are is that 21st Century Cures was so successful that people have been looking forward to seeing Cures 2.0," she said. "There is such overwhelming support for the concept of it in both the Republican Conference and the Democratic Caucus."
Then-Vice President Joe Biden worked with Upton to include his "moonshot" effort to cure cancer into that package, which President Barack Obama signed before he left office in December 2016.
Upton and DeGette met with Biden in March at the White House, along with a bipartisan group of lawmakers, to discuss pathways to end cancer and Biden's vision for ARPA-H, which the White House has insisted be housed within NIH.
DeGette said she's spoken to Chairman Frank Pallone, D-New Jersey, of the House Energy and Commerce Committee about having hearings soon on Cures 2.0.
The new text would require drug manufacturers to collect and report on patient experience data as part of a clinical trial and for the Food & Drug Administration to consider that data.
The bill also allows for the use of clinical and other "real-world" evidence and patient registries to confirm the predicted benefit of a therapy that's been proposed for accelerated approval, according to a bill summary.
"Part of the data that we should be assessing are patient-driven data — the whole point of Cures 2.0 is to make sure that the predicted clinical benefit of the therapy actually works in the patient, and that it's working for them," DeGette said.
The legislation would also require the U.S. Department of Health and Human Services to conduct a national study of the implications of "long" COVID-19, as well as a study on long COVID in children, and to develop a national strategy for testing and vaccine distribution to be used in future pandemics.