Applied Clinical Trials
The next version of the Cures Act will include provisions to advance research related to the COVID-19 crisis.
Congressional leaders are developing the next version of the 21stCentury Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster [see here]. A concept paper for a Cures 2.0 legislative package was recently unveiled by Reps. Diana DeGette (D-Col) and Fred Upton (R-Mich), who sponsored the Cures bill of 2016. It calls for a national COVID-19 testing and response strategy, with specifics for developing and administering vaccines and therapeutics and for modernizing and expanding U.S. biopharma manufacturing capacity to provide needed treatments for patients on a timely basis [see here].
Cures 2.0 continues and updates some of the main themes of the first Cures Act: support development of treatments for rare diseases, patient-focused drug development, diversity in clinical trials, expanded use of digital health systems, increased health literacy, and utilization of real-world data. FDA guidance would clarify methods for collecting post-market real-world evidence for products approved under accelerated approval pathways, and federal grants would support organizations that aide patients with rare diseases to facilitate patient participation in clinical trials. A public education campaign, moreover, would aim to counter concerns about the safety of vaccines to promote widespread vaccination.
Another goal is to boost industry investment in developing new antibiotics. Because these treatments are costly and unprofitable for biopharma companies to test and market, the legislation proposes additional financial support for both for pre-market studies and post-market production and subsidized higher reimbursement rates for antibiotics that address critical needs.
Federal government reimbursement and coverage for important new therapies would advance through earlier communication on upcoming breakthrough drugs by FDA and the Centers for Medicare and Medicaid Services (CMS). The final bill aims to outline additional proposals for modernizing CMS coverage policies, particularly related to reimbursement for cell and gene therapies and treatments for very small patient populations.
To further promote diversity in clinical trials, the new Cures legislation also supports efforts to modernize the Clinical Trials.gov website to make it easier for patients to identify studies open to enrollment. The aim is to make it easier for individuals to search for relevant studies and to understand enrollment criteria and study requirements. The National Library of Medicine (NLM) at the National Institutes of Health (NIH) has launched a modernization campaign for the 20-year-old CT.gov website, with the aim of streamlining and clarifying the process for trial sponsors to list and update study data and for patients to search for and retrieve desired information [see here]. A range of proposals were discussed last week at a NLM public meeting on the ClinicalTrials.gov modernization effort [see here].
Reps. DeGette and Upton also back a proposal to boost federal support for academic and independent medical research centers and laboratories that have been slowed or shuttered by the pandemic. A group of more than 150 lawmakers recently urged Congressional leaders to provide $26 billion in an anticipated fourth COVID-19 relief package to support important biomedical research programs [see here]. The funds would help fund researcher salaries, core research facility operating costs, and fellowships and research grants, as part of a strategy for preserving U.S. scientific infrastructure and protecting innovation.
Similarly, some of the Cures 2.0 provisions related to advancing research and regulatory policies designed to combat COVID-19 may be enacted more quickly as part of additional pandemic support legislation. Even so, the sponsors aim to introduce the full legislative package this year in order to gain enactment before Congress is under pressure to debate and approve the next FDA user fee renewal legislation in 2022.