After releasing a draft of the awaited 21st Century Cures Act 2.0 earlier this year, Reps. Diana DeGette and Fred Upton said that they anticipate to have the bill to the White House for signing before the end of the year.
The bill, dubbed Cures 2.0, builds on the original legislation passed in 2016 that aimed to streamline and improve medical care, research, drug development and more. The new legislation that DeGette and Upton pitched in their draft also builds on components of the White House’s infrastructure goals, such as supporting greater broadband and telehealth, as well as developing an advanced health research agency, ARPA-H.
DeGette and Upton spoke during Research America’s conference this week about the importance of the original Cures Act amid the emergence of the COVID-19 pandemic, but also the urgency of wanting to pass this legislation amid health challenges that have surfaced with the pandemic as well.
“One thing that we realized when we got into the pandemic was how important 21st Century Cures was, because many of those provisions actually helped us to develop the vaccine as quickly as we did, through the administration’s Operation Warp Speed and then also help with many other provisions dealing with COVID,” DeGette said. “But one thing we learned throughout the process was that we just have to be better prepared in the future, because I don’t think that COVID-19 is going to be the last potential pandemic that we have.”
Taking lessons learned from this pandemic, DeGette and Upton applied different provisions in their new legislation to improve the public health and medical preparedness of the country for both now and the future.
Cures. 2.0, for instance, directs the Health and Human Services secretary to convene a national series of meeting to serve as the basis of an ongoing learning collaborative with key sectors of the health care community to help the country understand COVID at a deep level. It will also require development of a national strategy based off lessons learned from the current pandemic to mitigate future public health emergencies, as well as a pandemic preparedness and rare disease support program to assist individuals who have rare diseases and their families during health emergencies.
DeGette and Upton emphasized that the boom in telehealth amid the pandemic is also a key provision that they want to keep and build on in Cures 2.0, noting the increased accessibility and potential it holds after the current pandemic is over.
“We’re going to have an emphasis on telehealth, but we’re also seeing as we hopefully pass an infrastructure bill that we have billions of dollars in that for broadband to connect communities, whether they be in urban or rural setting,” Upton said. “We hope that this is overwhelmingly bipartisan as we really look to introduce it this month in September.”
Cures 2.0 also takes advantage of new technologies and modernization efforts that can improve approval and regulatory processes in the health space, as well as bring more patient empowerment and engagement in drug development and clinical trials.
“One of the real cornerstones of the bill is to try to do everything we can to make sure that patients; voices are heard throughout the clinical trial process,” DeGette said. “If you can collect patient experience data and apply it through product development, that can really make sure that patients’ needs are addressed, and so 2.0 requires manufacturers to collect and report on patients experiences as part of the clinical trials, and then it also requires the FDA to consider that data in the regulatory decisions.”
DeGette added that Cures 2.0 will also look to modernize the Centers for Medicare and Medicaid Services to speed up agency decision-making so that the agency can provide faster and more predictable decisions on new therapies.
Not only are DeGette and Upton trying to improve federal health and public health processes with existing technologies and solutions, but they are also looking toward the future development of health technology by collaborating with the White House on the establishment of ARPA-H. The White House proposed developing ARPA-H as an independent advanced projects agency within the National Institutes of Health, much like the military’s DARPA. The legislators are now working to support that initiative by advocating for it in Cures 2.0.
“The president wants [ARPA-H] included within the NIH, so that’s going to happen, and we’re going to make sure that it’s independent enough in that they can chart their own course,” Upton said. “More exciting news is that the appropriators now … have included billions of dollars for this initiative. … It is our absolute aim and goal to have this bill, including ARPA-H, on [Biden’s] desk before this year is out.”