The 21st Century Cures Act is here to stay. Now what?

There’s something for just about everyone in the 21st Century Cures Act, which will now become law once it lands on President Obama’s desk. There’s more money for cancer research, an initiative on the opioid epidemic. There are even a number of initiatives related to mental health that drew strong support from the advocacy community.

But it’s the provisions designed to ease the regulatory burden of proof around new drug indications that has the few remaining critics rankled. In particular there’s a provision allowing for “real-world” evidence of efficacy to back a broader label, replacing clinical data with data summaries. The change could be worth billions in added revenue. And the small number of legislative opponents left to fight the bill tried, completely unsuccessfully, to make that a sticking point that would bring the whole thing down.

“A homeopath would love this provision, and, I’m sure, so would drug companies,” David Gorski, an oncologist, tells the LA Times. “Why bother with the time, bother and expense of those pesky clinical trials to get your drug approved for additional indications, when you can rely on clinical experiences?”

Gorski also wasn’t too happy about provisions allowing drug companies to promote off-label uses of a drug to insurers.

As far as the critics are concerned, the agency has already become far too lax about approving most everything that comes its way. Last year, that figure was about 9 out of 10.

This year, the big wave of new drug approvals is going to subside considerably, partly because there were fewer applications and partly because manufacturing snafus delayed a lineup of new treatments. But you can be sure that any drug that makes its way out into the market now that causes unexpected side effects will get prominent attention as a symptom of the legislative embrace of faster approvals. In the meantime, the wind in Washington DC is blowing ever stronger in biopharma’s direction, even while a few backlashes on pricing still force the occasional blowback.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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