- The Senate voted 94-5 on Wednesday to pass the 21st Century Cures Act.
- The legislative package will now head to President Obama's desk, who is expected to sign the bill into law.
- Over the course of 10 years, the Cures bill authorizes the National Institutes of Health to spend $4.8 billion toward funding the Cancer Moonshot ($1.8 billion) and the precision medicine and the BRAIN Initiative efforts ($3 billion).
The sweeping bill has a lot going on within its 996 pages and is not without controversy. About three years of work and efforts from 1,400 lobbyists for 400 companies went into the making of this $6.3 billion package. It seeks to deliberately speed medical research and treatments.
Sen. Elizabeth Warren (D-MA) and Sen. Bernie Sanders (I-VT), had previously stated they think the bill is too favorable to pharmaceutical companies and while Cures authorizes the $4.8 billion spending for NIH, the actual money must be appropriated by Congress. This means the NIH funds must get fresh approval every year. In addition, Cures authorizes the FDA to receive $500 million to help speed up product approval processes, which some critics say weakens safety and efficacy standards. For example, when drug makers seek to expand approvals for their marketed products, they will be allowed to include "real world evidence" rather than additional placebo-controlled trials in their applications.
The legislation also clarifies low-risk medical devices will not be regulated as a medical device under the FDA. This includes your FitBits, your smart shirts that can track your physical activity or your EHRs for that matter. This is important from a health IT developer perspective, Stephanie Zaremba, director of government and regulatory affairs at athenahealth, told Healthcare Dive, as investors won't face the uncertainty that the health app could be blocked by the FDA before gaining a return on investment.
"Giving certainty is really important for investing purposes," Zaremba says, noting she believes such a law will help get more innovative, low-risk technology in patients' hands.
An interesting analysis from Stat's Sheila Kaplan notes the package lacks a fair number of deadlines for some of its implementations when it comes to changes at the FDA.