Memorandum
Today President Obama signed the 21st Century Cures Act into law, following its passage by decisive margins in both the House of Representatives (392-26) and the Senate (94-5) earlier this month. The bill provides >$6 billion in discretionary medical research funding (including $4.8 billion to the NIH and $500 million to the FDA – finally, how fantastic to see the under-resourced NIH and FDA receive funds!) and proposes a revamp of the FDA approval process (see our previous report for a complete breakdown of the bill’s provisions). This bill has been long-awaited and much anticipated – we’ve been tracking its progress for quite some time – and many were skeptical early on that it would make it into law, including us. This version of the bill is markedly different from the original that passed the House in July 2015 but was subsequently voted down by the Senate. Compared to the current $4.8 billion allocated to the NIH over 10 years (with the stipulation that these funds must be reauthorized by a congressional vote each year), this earlier iteration instead provided $10 million in guaranteed, mandatory funding. The discretionary nature of the current bill’s funding is one troubling element, in our view, especially in light of the uncertainty surrounding President-elect Trump’s plans for healthcare. Nonetheless, the law has garnered wide bipartisan support from advocacy groups, industry, and the Obama administration itself, which released an official statement saying that “this legislation offers advances in health that far outweigh these concerns.” We excited by the potential for the current bill to stimulate innovative medical research, shorten the time gap for new therapies to reach real-world patients, and create a structured framework for patient experience data to be considered in the regulatory review process for drugs and devices. These are three areas that deeply affect people with diabetes, and we so hope that this highly-anticipated bill is carried through in the years ahead and that diabetes work itself is touched.
-- by Abigail Dove, Helen Gao, and Kelly Close