The latest iteration of this legislation was released on November 25 and combines many of the provisions from the original Cures Act. Some of the newer areas of focus include mental health and opioid abuse prevention. Additionally, an altered method of paying for the legislation is incorporated into this proposed legislation.
In July 2015, the House passed a previous version of the 21st Century Cures Act, but the effort stalled after being referred to the Senate. The Senate then began a parallel effort by combining existing Senate bills into a smaller package, but it was never brought it to a floor vote.
Key provision changes include the following:
- Funding levels for both the Food and Drug Administration (FDA) and the National Institute of Health (NIH) have been reduced. New funding for the FDA is now at $500 million (previously $550 million) and NIH is now at $4.8 billion (previously $9.3 billion). Despite these reductions, funding for precision medicine and the BRAIN initiative remain in place.
- Provisions in this bill are now organized into more therapeutic areas, as well as class specific. The legislation provides $1 billion in grants to states to help them combat opioid abuse. It also funds mental health and family services. Provisions related to regenerative medicine, antimicrobials, and medical countermeasures were also added.
- Funding for the bill mainly comes from a drawdown of the Strategic Petroleum Reserve (SPR) and other appropriations previously allocated to the ACA’s Prevention and Public Health Fund and territory funding. Other offsets include Medicare and Medicaid payment changes.
“Cures has generally had broad bipartisan support because many of its provisions are intended to help get medical products to patients faster without sacrificing FDA’s central safety and effectiveness mantra,” said Jay Jackson, manager at Avalere Health. “Provisions that were debated and not included in the current iteration of the bill - such as FDA guidance on off-label communication and laboratory-developed test regulation, may well reappear through further