If I had a penny for every time the phrases “21st Century Cures” and “spur new drugs and devices” appeared in one of my stories over the last two or so years, let’s just say I wouldn’t get quite so excited about the unlimited free coffee we get at work.
Actually wait—that’s not true.
I will always be excited about free coffee.
But you get the idea ...
(Oh and in case you’ve been in the dark, 21st Century Cures was that giant, bipartisan biomedical innovation law enacted last December to … wait for it … spur new drugs and devices. Basically, the average cost of developing a new drug is something like $2.58 billion and takes more than 10 years and this was a move to clear out some of the bottlenecks.)
For anyone who hasn’t yet memorized all 312 pages of Public Law 114-255 (if you have, please come talk to me!), the Food and Drug Administration just released a new tracker to make it easier to stay updated on FDA-related provisions. The agency also just made public the work plan it sent to Congress last month on how it would spend the new money Congress gave it through Cures.
Faster Cures, the medical research think tank of the Milken Institute, also developed a neat Cures tracker back in February. This one actually allows you to filter by agencies and topic, statuses, and even the topics Faster Cures isn’t tracking, such as some of the Medicare and Medicaid provisions.
But the FDA tracker was one part of this larger announcement on how the agency plans to implement the Cures law specifically. The agency also made publicly available the final work plan it sent to Congress last month on how the FDA plans to spend the additional $500 million it got through the Cures innovation fund.
FDA Commissioner Scott Gottlieb also announced the agency plans to roll out a new “Innovation Initiative,” which he wrote in a July 7 blog will be a comprehensive effort “aimed at making sure our regulatory processes are modern and efficient, so that safe and effective new technologies can reach patients in a timely fashion.”
Whenever it rolls out, we will definitely be tracking this new initiative too.
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