
New Cures 2.0 Legislation Advances Biomedical Research and Care
Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.
Leading legislators have
A likely scenario is that next year, Cures 2.0 will be incorporated into a broader legislative package to reauthorize several FDA user fee programs that provide critical funding for the agency. Revised fee programs for drugs, generic drugs, biosimilars, and medical devices need to be approved by next summer to meet the Sept. 30, 2022 deadline, a scenario that encourages policymakers to add to the fee measure a wide range of pet projects and policy updates related to public health, biomedical research, and access to medicines and care.
The new Cures legislation similarly
FDA would advance digital health technologies, expand the use of real-world evidence, and support novel trial designs, such as decentralized trials. The policymakers also call for FDA to accelerate designations for breakthrough and regenerative medicines, with specific attention to developing more information on CMC (chemistry, manufacturing, and controls) for expedited programs. FDA and the Centers for Medicare and Medicaid Services would communicate earlier on breakthrough therapies to facilitate coverage, and sponsors could utilize a broader range of evidence to fulfill postapproval study requirements for drugs receiving accelerated approval.
The measure also looks to continue certain more flexible coverage policies authorized for the health emergency, notably wider use of telehealth under Medicaid and Medicare and continued coverage for breakthrough devices and other innovative technologies. It facilitates diagnostic genetic testing of children with rare diseases and authorizes pharmacogenetic consultations for the elderly.
The House Energy & Commerce Committee will consider the measure with an eye to gaining agreement on a package likely to win Congressional approval next year. In budget deliberations earlier this year, the legislators dropped the Biden administration’s pricey ARPA-H proposal, and that may occur again as federal funds get tight. Industry supports the overall bill but will not want any extensive policy debate to delay user fee reauthorization.
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