FDA, Politics

It’s the law: Obama signs widely popular 21st Century Cures Act

In the end, the 21st Century Cures Act looked like an old-time bill, laden with extras for cancer research, antibiotics, the opioid epidemic and even Alzheimer’s, which has managed to resist just about everything thrown at it so far. It even had the kind of bipartisan support that you don’t see much these days in Washington D.C.

Vice President Joe Biden was there to savor the moment as President Obama inked the nearly 1,000-page initiative, which helps capture more money for cancer drug research — his last big initiative. And the biopharma industry reps, along with some 1,300 lobbyists, were happy to see promises of shorter, swifter drug approvals with new FDA funding.

Only Elizabeth Warren and Bernie Sanders, joined by three fellow Senators, were willing to cast their votes against the law. Don’t be surprised to see elements of that opposition woven into the 2020 campaign.

For BIO, this is the biggest single piece of new legislation to pass since the ACA included longterm safeguards against biologics competition. Now it will have to make sure that no one tampers with those provisions as the new Trump administration goes back and starts to undo that complex piece of legislation.

But there are plenty of little provisions in the bill that could affect a wide variety of researchers and biotechs. Case in point: Biopharma companies will need to prominently post their policy on compassionate use, which is a rarity these days.

The NIH director is also in a position to require researchers to share data from NIH funded studies, writes Francis Collins in an article for the NEJM. And there will be a new office at the NIH charged with finding new opportunities for young researchers.


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