21st century cures act

Here comes the 21st Century Cures Act

Bills passes House with broad bipartisan support; Senate approval likely

Although it’s being called the “the biggest health reform bill since the Affordable Care Act,” and has been promoted in an unusually aggressive, multi-year effort by Rep. Fred Upton (R-MI), chair of the House Energy and Commerce Committee, the 21st Century Cures Act boils down to some additional funding for NIH, some support of expanded treatment for opioid addiction, and potential changes in FDA review processes for drug approvals.

Which is not to minimize the Act’s impact. It will bring $4.8 billion in additional funding to NIH, much of which is targeted for initiatives supported by the White House (which made the Obama Administration a supporter of the bill’s passage): the Cancer Moonshot (announced at this year’s State of the Union Address in January); the Brain Initiative, a longterm research project into neurology, and additional support for rare diseases. The pediatric review voucher—a mechanism to reward companies pursuing treatments for infants with a voucher that can be sold to anyone else for an FDA priority review—has been renewed.
Provisions to streamline FDA drug reviews, in part by allowing broader use of real-world data (rather than a formal double-blind trial) are included, but how those will work out for actual FDA reviews remains to be seen. An attempt to revise the Physicians Sunshine Act, which created the Open Payments System where CMS reports on payments to prescribers by healthcare product suppliers (including the pharma industry), was removed at the last minute at the behest of Sen. Chuck Grassley, who had long supported the system originally passed as part of the Affordable Care Act.

Evidence of how contorted the mechanisms for getting the bill passed can be seen in how it is funded: a selloff of crude oil stored in the Strategic Petroleum Reserve, and not a straightforward addition to the national budget. However, while the bill’s offsets are mandated for its duration, the actual authorizations will need to be re-approved by Congress annually—something that puts that money at risk in future Congresses. Even at best, the bill adds about $480 million annually to the NIH budget—a big boost, but with an annual budget around $30 billion, it doesn’t represent a new era in medical research.

It could be, too, that the bill will represent a high-water mark for Congressional lobbying: reportedly, some 1,455 lobbyists were involved in its passage after Upton started writing draft legislation in 2013. If President-elect Trump’s sloganeering to “drain the swamp” in Washington is to be believed, that activity will fade.

UPDATE, DEC. 7: The 21st Century Cures Act passed the Senate by a 94-5 vote, and is scheduled to be signed into law by President Obama on Dec. 13.

4 comments on “Here comes the 21st Century Cures Act

  1. […] of its passage in the current Congress are essentially nil, given that it didn’t figure in the recently passed 21st Century Cures Act (a law that in some ways will accelerate the approval of more sole-source drugs). That bill also […]

  2. […] Taltz (ixekizumab) for plaque psoriasis. And, although the workings of the recently passed 21st Century Cures Act remain up in the air until FDA regulations come out, that law’s loosening of evidence standards […]

  3. […] Another element of the Marathon situation is that it also received a pediatric drug voucher, a sort-of “get out of jail free” ticket that entitles the holder to an accelerated review of another drug before FDA; this voucher can be used by Marathon or can be sold to another company. As the time savings can have considerable value (Sanofi paid $65 million to obtain such a voucher when it expedited review and approval of its PCSK9 drug in 2015), the voucher is meant to provide additional compensation to a drug company pursuing the uncertain economic return of a rare-disease drug for pediatric populations. (The voucher program was renewed and extended when the 21st Century Cures Act was passed in December.) […]

  4. […] is language in the newly passed 21st Century Cures Act that requires US manufacturers to have “publicly accessible compassionate use policies” in […]

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