The House of Representatives has voted overwhelmingly to pass the 21st Century Cures Act, a contentious, long-gestating piece of legislation with implications for drug approval standards at FDA. Members of the Senate are now set to discuss—and expected to pass—the legislation.
If the bill comes into force, NIH is in line to receive $4.8 billion in funding over the next 10 years. The cash is earmarked for the three landmark big science initiatives of President Obama’s time in office: The cancer moonshot, the BRAIN Initiative and the Precision Medicine Initiative. In theory, the funding provision secures the future of the programs, although, as some lawmakers have noted, the flow of money must be reauthorized each year.
The funding boost for NIH ensured the bill secured bipartisan support—it passed in the House by 392 to 26—even though lawmakers and observers have misgivings about aspects of the legislation.
Nonprofit lobbying group Public Citizen has called the act “a threat to FDA standards,” despite lawmakers removing some of the controversial proposals that caused progress of an earlier version of the bill to stall. Public Citizen fears requirements for FDA to develop a program for evaluating real-world evidence and accept data summaries for supplemental new drug applications will weaken standards.
These are long-standing concerns for critics of the bill, who helped head off the advance of an earlier version of the legislation in the Senate last year. The latest version, while generally an attempt to placate critics through increased funding and other tweaks, features some new sections that have caused consternation. Notably, plans to create an accelerated approval pathway for regenerative medicines have caused agitation in some quarters, although they could be more favorably received by companies developing such treatments.
The regenerative medicine accelerated approval pathway is part of a clutch of proposals intended to cut the time it takes for drugs to reach patients while maintaining checks and balances on efficacy and, particularly, safety. Yet, some people are skeptical about whether the act will achieve this goal. And, given FDA already moves faster than its peers, there are doubts about whether tweaks to the speed-safety balance are even necessary.