The 21st Century Cures Act: Still alive, and still poised to endanger patients

[HuckleB]

http://scienceblogs.com/insolence/2016/05/20/the-21st-century-cures-act-still-alive-and-still-poised-to-endanger-patients/

"it was less than a year ago that I described a bill wending its way through Congress called the 21st Century Cures Act “old vinegary wine in a new bottle.” The reason I characterized the bill that way was because it really was nothing new and it rested on a very old fallacy, namely that the only way to speed up medical “innovation” is to weaken the FDA and its standards for drug and medical device approval, which is exactly what the 21st Century Cures Act would do if passed into law. It’s basically the American cousin to the British Saatchi Bill, which in essence proposed to do very similar things, but even more so, so much so that Andy Lewis referred to it as the “quack’s charter.” Fortunately for the British, the version of the bill that ultimately passed bears little resemblance to the original Saatchi bill and lacked the most onerous removals of patient protections. I’m not so optimistic that the American Saatchi bill will be so watered down.

...

When I wrote about this misbegotten bill, I pointed out just this aspect of it. What I perhaps didn’t emphasize enough, is that the bill is in essence a “grand bargain,” as Silverman puts it. The bargain is this: Congress will step up funding for the NIH in return for a loosening of regulatory standards at the FDA. Not surprisingly, Silverman thinks that this is a bargain the American people should turn down. Even less surprisingly, I agree even more strongly.

...

Unfortunately, as I discussed last year, the NIH and by extension the American public don’t get very much for giving up a lot, as this is a bad deal. That’s not to say that there aren’t some good things. For example, the 21st Century Cures Act doesn’t add that much to the NIH budget, a 3% increase per year for three years plus $1.86 billion a year “innovation fund” to support precision medicine initiatives and young scientists. Given that the current budget of the NIH is approximately $32 billion, 3% per year is less than $1 billion a year, which means that nearly two thirds of the increase is spoken for, much of it for “precision medicine.” Having been around, I’m also cynical enough to doubt that the part of the funds allocated to “young investigators” will actually benefit young investigators as much as Mr. Alexander thinks it will. If Mr. Alexander is willing to pump $2.86 billion a year for three years into the NIH, it would do a lot more good if there were no strings attached to the budget increase.

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The 21st Century Cures Act is cynical politics played to increase pharmaceutical company profits. It is not, nor has it ever been, about protecting patients. Although its advocates genuinely believe that its purpose is to bring cures faster to patients who need them, the 21st Century Cures Act will do no such thing, and tying changes in the FDA regulatory framework to increasing NIH funding is the ultimate cynical political ploy to gut the FDA and turn back the clock on drug development at least 50 years."

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Not good, and I can only imagine how much worse it could get under a President Trump.