- The House of Representatives on Friday overwhelmingly voted to approve the 21st Century Cures Act—a significant FDA and drug development reform bill expected to usher in some of the biggest regulatory changes to healthcare since the passage of the Affordable Care Act.
- The bill was widely expected to pass the chamber considering that it made it through the large and influential Energy and Commerce Committee in a unanimous vote—a rare feat in that committee for legislation of this magnitude.
- On Friday morning, the full House voted on a series of amendments to the bill before a vote on the final product. One particularly contentious amendment, from Rep. Dave Brat (R) of Virginia, would have made the significant new funding for the NIH provided in the bill discretionary rather than mandatory. That was seen as a poison pill measure and was defeated 141-281.
All eyes have been on this bill since its formal introduction in January, and for good reason: 21st Century Cures would speed up drug development efforts, provide more funding to the NIH and FDA, grant exclusivity to orphan drug products, make it easier for pharma companies to make the economic, value-based case for their drugs to providers, integrate patient voices into the regulatory and drug development process, and much, much, more.
The legislation's widespread bipartisan and cross-industry support has been notable. It's attracted the support of stakeholders ranging from pharmaceutical companies, to patient advocacy groups, to federal regulatory and research agencies.
But in recent days, some other stakeholders have expressed concerns that the bill could actually be dangerous from a patient safety perspective by relaxing certain FDA regulatory hurdles (such as allowing for the use of surrogate endpoints and antibiotic approvals based on early-stage clinical trials). Generic manufacturers have also balked at the orphan drug exclusivity measures, arguing that they will increase costs and decrease access for rare disease patients. On the other hand, pharma companies and patient groups might respond that when it comes to unmet needs, the more options there are for patients, the better, and that exclusivity provisions are a needed carrot for encouraging development for diseases that won't have a particularly wide market reach.
Now that the bill has passed the House, the big question is: What will the Senate's version of the legislation look like? There's already been some evidence that companion bills in the Senate will diverge from the House-passed measure, sometimes in significant ways (it is seen as probably a less comprehensive bill). However, lawmakers expect differences to be ironed out during the conference committee process.