The HHS would have to develop a national strategy for beefing up the nation’s ability to spot and test for Covid-19 as well as future outbreaks, under a proposal from two lawmakers looking to follow up on their landmark biomedical innovation law.
Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) Monday released what they called a concept paper, a precursor to a draft bill that outlines their priorities for Cures 2.0, the follow-up legislation to the 21st Century Cures Act (Pub. L. 114-255). The Department of Health and Human Services would have to create a national plan for testing, data sharing infrastructure, vaccines, therapeutics, and a strategy to have medical supplies ready to mitigate current and future pandemics, under their proposal.
The announcement indicates lawmakers continue to move forward on improving their 2016 law amid the pandemic. Prior to the pandemic, DeGette and Upton wanted to issue a draft Cures bill in the first few months of 2020, as discussion began last fall. They plan to introduce Cures 2.0 some time this year, DeGette said.
The bipartisan duo said they hope to incorporate the provisions that address pandemic response and improving clinical trials in the fourth or fifth round of Covid-19 response bills, while they continue to massage other provisions such as modernizing payment models under the Centers for Medicare & Medicaid Services.
“As our nation faces this unprecedented health-care crisis, Fred and I feel like it’s really important that we continue our efforts to modernize the way that we treat the world’s most vexing diseases as has sort of poignantly been brought home to us,” DeGette said in a telebriefing.
“What we’re hoping is this new bipartisan bill will build on the successes of 21st Century Cures and help us take the next steps toward finding and delivering more lifesaving discoveries and cures,” she said.
The 2016 law aimed to accelerate the discovery and development of new medicines and devices, whereas the forthcoming bill looks primarily to improve the delivery of those treatments while overhauling the clinical trial process and modernizing the CMS and the Food and Drug Administration.
The concept paper identifies six major buckets of Cures 2.0, including pandemic surveillance and response:
- Improving pandemic surveillance and testing capabilities, commercializing antimicrobial resistance products, and expanding vaccine education and surveillance.
- Creating educational and training programs for caregivers.
- Increasing diversity in clinical trials.
- Empowering patients’ decision-making with better health literacy and access to health information.
- Modernizing the FDA by providing grants for innovative clinical trial design and patient-focused drug development to improve science in these areas.
- Finding ways for the CMS to keep pace with technological and scientific advances such as potentially curative therapies that have one time administration costs that can reach the millions.
The paper further indicates they’re looking to take a similar approach to 21st Century Cures, which included more than a year of feedback and solicitation from stakeholders before unveiling a draft bill in 2015 and passage in 2016. The concept paper stems from nearly 500 comments, the lawmakers said.
DeGette and Upton said they’re putting together a memo for House Energy and Commerce Chairman Frank Pallone Jr. (D-N.J.) and Ranking Member Greg Walden (R-Ore.) to consider putting the pandemic and clinical trial portions into the next round of Covid-19 funding bills.
“We’re really excited about this concept paper. The hard work now comes to build a bipartisan consensus behind it, to work with our leadership and see if in fact we can’t include some of these provisions in either a phase four or a phase five of what Congress does to get done this year,” Upton said.