Does anyone have specifics on 21st century cures act, Obama signed yesterday

The 21CCA is a huge boon for researchers. It will expand funding for translatable clinical research by billions. Unfortunately, it comes at a high price. Ameet Sarpatwari, JD PhD explains the issues quite well here. Life science really gutted this one.

  1. High risk medical devices can now be approved with substantially less evidence. NYT did a great piece on how device manufacturers got their fingers in the pie on 21CCA.

  2. Orphan drugs - already WILDLY profitable - will receive an additional 6 months of market exclusivity. There are a number of other benefits gleaned by going after orphan diseases, pharma certainly didn't need any more incentives.

  3. "Medical education" payments will be exempt from the Sunshine Payment Act. But life science won't use them to inappropriately influence shady physicians, promise!

  4. MDR-focused antibiotics (what's the right term for this?) that go through the new expedited approval process can be approved based on phase II data alone. That means no large trial demonstrating efficacy.

The article highlights a bunch of other points and is absolutely worth reading, but basically we've received lots and lots of government funding in exchange for letting life science shit all over the regulatory framework they already abuse.

/r/medicine Thread