21st Century Cures Act could use a second look; It's time for the FDA to open up
Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.
The 21st Century Cures Act would benefit from a closer look before it’s passed
A slightly modified 21st Century Cures Act has been gaining momentum in the lame duck Congress, with Democrats and Republicans coming together in a rare kumbaya moment to back a bill industry lobbyists have been pushing hard for the past two years. It’s not hard to see why. There’s something in here for everyone, with plenty to rile the left in the form of an even warmer welcome for drug developers. One of the biggest plums is an offer to consider “real world evidence” in approving drugs. It should not automatically be assumed that the FDA will willy-nilly ignore long established guidelines on clinical data in approving drugs, but the agency has already gone a long, long way to accommodating developers and speeding approval timelines. To a fault. Perhaps rather than just rolling this out, the Senate should make some thoughtful adjustments. But it is clear that the mood in Congress is calibrated to supporting the industry, rather than punishing it. That kind of fair wind has been blowing in biotech’s favor for 5 years now. We’re happy to see the sails that have been filled. We just hope it doesn’t end up with many of these ships, and the patients that board them, on the rocks.
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