Medical research, for both pharmaceuticals and medical devices, is slated to receive a big boost under a new federal law. President Obama recently signed the 21st Century Cures Act into law, a measure intended to bring additional financial resources to back innovative medical research. When that research develops into promising medical treatments, the law also aims to speed up the review and approval processes to bring these new products to patients.
First, let’s look at the money. In total, the Cures Act encompasses more than $6.3 billion in funding, UPI reported. Of that total, about $4.8 billion will go toward efforts overseen by the National Institutes of Health. The funding creates an “Innovation Fund” that will support targeted research projects, according to National Law Review, including Vice President Biden’s cancer “moonshot” program; the BRAIN Initiative pursuing new technologies for the brain; and the Precision Medicine Initiative, which aims to collect patient data that can be used to develop personalized medical treatments.
When those therapies advance to the FDA for regulatory review, they could have a smoother pathway that takes into account new sources of evidence. In addition to weighing clinical trial results, the Cures Act calls on the FDA to include “real world evidence” and patient experience as consideration factors for approval decisions, UPI reported.
The Cures Act also includes provisions for medical devices. Diagnostics and device developers large and small might be particularly interested in the Cures Act’s approach to speeding up the regulatory review of new devices. The law calls on the FDA to create a “Breakthrough Devices” program, which would offer priority review for those devices that treat or diagnose life threatening conditions, explains Mass Device. This faster pathway would apply to products addressing conditions for which there are no other products that are FDA cleared or approved. This new provision builds on the current “Expedited Access Pathway” by adding priority review to devices that would ordinarily be subject to the 510(k) clearance or premarket approval.
The place of software in medical device regulation has been an area of ongoing uncertainty. The Cures Act injects greater clarity in this area, stating that the FDA will not regulate medical software that uses big data to aid in clinical decision-making, Mass Device explained.
The Cures Act is a wide-ranging measure totaling more than 1,000 pages.
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