21st Century Cures (But Doesn't Prevent) Act

Soy un perdedor
I'm a loser baby, so why don't you kill me?
-Beck (Loser)

There was a lot of excitement yesterday when the US Senate approved the 21st Century Cures Act, which would increase NIH funding, address issues with the mental health delivery and alter the approval process for pharmaceuticals and devices. Unfortunately, along with the winners there are several losers in this legislation.

And the big loser is?  - The Prevention and Public Health Fund. Dan has written often (here, here, and here) about how this fund is a frequent target for cuts. And this time, it seems even worse. Per reports, "[the bill] also cuts $3.5 billion, or about 30%, from Obamacare’s Prevention and Public Health Fund, which fosters work to prevent Alzheimer’s disease, hospital-acquired infections and other conditions."

So apart from the Cubs win, we can all agree that 2016 was a real loser for the HAI and public health communities.


  1. Also shiny and attractive is antibiotic discovery; there is language to help make a simpler and expedited pathway to allow use of experimental antibiotics for limited use populations – such as CRE or extremely drug resistant gram negative infections. Basically, without conventional clinical trials to prove that the antimicrobial actually decreases morbidity or mortality—but rather on small studies, phase 2 data. In theory this can help patients without many or any options received antibiotics that are untested. I agree with the Society for Healthcare Epidemiology of America (SHEA) which identify a part of the bill to support: SHEA supports the “Antimicrobial Innovation and Stewardship” provisions (http://www.shea-online.org/journal-news/press-room/press-release-archives/501-infectious-diseases-experts-show-support-for-policies-to-improve-use-of-antibiotics-in-the-21st-century-cures-act).
    However, under the surface there is some cause for concern. There are few safeguards to restrict prescribing to only the most appropriate patients. The NEJM commentary suggested that if “passed in its current form, the bill would also provide hospitals with a financial bonus for administering costly new but unproven antibiotics, which could encourage their more widespread use.” This part of the CURES act comes from a previous bill (ADAPT Act) I was more familiar with which called for monitoring of such prescribing, but I know (for a fact) that the governments capacity or ability to track newly developed antibiotics on a national scale doesn’t exist, and if it did, would be highly variable in quality and accuracy. I do not think the bottleneck for new antibiotic availability comes from an overly burdensome regulatory framework, but more likely comes from the lack of longevity of income from selling the product, just as hospitals all begin to ramp up antibiotic stewardship programs there will be less incentive for industry to make these drugs. There clearly needs to be incentives to industry to make novel antibiotics since it is only borderline profitable, but compromising on patient safety may not be the best route.

  2. Ouch. But love the Beck reference!

  3. So, why were IDSA and SHEA such big supportors of the bill that helps pharmaceuticals by weakening the FDA and cuts public health?


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