The 21st Century Cures Act – a long-debated bill that would allocate extra funding to the National Institutes of Health as well as effectively speed up the FDA approval process for drugs and devices – is headed for a House vote this week.
The latest version of the bill, which was released over the holiday weekend, allocates $4.8 billion to the NIH over the next 10 years. The funding would go towards three signature Obama administration initiatives that drive innovation in digital health: The Precision Medicine Initiative, the BRAIN Initiative, and the Cancer Moonshot. It would also grant an additional $1 billion to address the opioid crisis, and allocate $500 million for the FDA.
The Cures Act would also put different evidence standards on the FDA’s drug and device approval, effectively speeding up the process. As Politico reports, the bill would remove requirements that doctors and teaching hospitals report payments from drug and device companies for continuing medical education or for medical journal reprints and textbooks, and would also exempt physicians from reporting indirect payments for speaking fees.
The bill has gotten considerable attention for the amount of lobbying it has attracted. As Kaiser Health News reports, more than 1,455 lobbyists representing 400 companies, universities and other organizations pushed for or against an earlier House version of the bill this congressional cycle, according to federal disclosure forms compiled by the Center for Responsive Politics. That amounts to more lobbying activity than any of over 11,000 bills proposed in the 114th Congress, and is second only to MACRA as the most-lobbied healthcare bill since 2011, KHN reports.
For those operating under Precision Medicine Initiative funds, the bill is a welcome funding opportunity to improve research and speed up the process. In an explanatory piece written by NIH Director Dr. Francis Collins and NCI director Dr. Harold Varmus that was published in the New England Journal of Medicine prior to the Initiative’s passing, experts said such research programs were essential to “encourage creative approaches to precision medicine.”
"Many possibilities for future applications spring to mind: today's blood counts might be replaced by a census of hundreds of distinct types of immune cells; data from mobile devices might provide real-time monitoring of glucose, blood pressure, and cardiac rhythm; genotyping might reveal particular genetic variants that confer protection against specific diseases; fecal sampling might identify patterns of gut microbes that contribute to obesity; or blood tests might detect circulating tumor cells or tumor DNA that permit early detection of cancer or its recurrence,” the authors wrote.
For digital health companies building software for clinical decision support, the bill brings clarity over how the FDA would seek to regulate them. As health software companies are working on technology to help doctors do a more thorough job in both diagnosis and treatment decision-making (through apps, telemedicine and digital references), there is a real need for clinical guidelines, said Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA and digital health.
“Health software companies are working on exciting technologies that help doctors do a more thorough job in both the diagnosis and treatment decision making process. Software can analyze patient data quickly, and through reference to the literally millions of peer reviewed articles, clinical guidelines and other such clinical intelligence, make recommendations to the physicians,” Thompson wrote in an email to MobiHealthNews. “But there has been a cloud over this industry in the form of an uncertain regulatory environment.”
Specifically, Section 3060 provides some “much needed, high level clarity,” Thompson wrote.
“For example, the legislation incorporates the common sense notion that if a physician has access to all of the underlying information such that the physician can double check the basis for any recommendation, then the software is really simply supporting the physician in his or her practice,” wrote Thompson. “Such software should not be FDA regulated, and the legislation reinforces that point.”