FDA, Politics

House lines up biotech lollipops as support grows for an epic 21st Century Cures Act

Now that Donald Trump is headed to the White House with plans to gut ObamaCare, the House has fielded a new version of the 21st Century Cures Act in a bid to push through a bill now that includes fresh promises of an even speedier and more responsive FDA. And now that the Democrats and Republicans have reached an agreement on how to fund the measure, plucking cash from the carcass of the Affordable Care Act, there are good odds that the House and Senate could reach an agreement on a final bill in the not too distant future.

According to Kaiser Health News, more than 1,400 lobbyists have taken a crack — for and against — various sections of this bill. And that helps explain why this compromise bill weighs in at an epic 944 pages.

Rachel Sachs, a professor at Washington University who’s been following this bill closely, notes that some of the original goodies for drug and device makers have been removed, including one section that would have allowed developers to circumvent the FDA’s approval process.

So what’s in? A special mandate for the NIH to support young scientists looking for first-time grants; the priority review voucher program that the FDA hates; an extra $500 million in funding for the FDA to move drugs and devices along faster over the next 10 years, and so on.

Here’s a 44-page summary to help digest what’s coming. You’ll find this in the section on speeded drug development, a promise that Trump made in his post-election game plan. The bill:

• Establishes a review pathway at FDA for biomarkers and other drug development tools that can be used to help shorten drug development time and reduce the failure rate in drug development.

• Allows sponsors of genetically targeted or variant protein targeted drugs to rely on data for the same or similar technology from previously approved applications by the same sponsor.

• Does not alter the existing approval standards for drugs.

There have been some high-profile scandals this year to suggest that the FDA may have acted hastily in approving drugs or getting them back into the clinic after a safety mishap, most recently with Juno’s new clinical hold in the wake of more patient deaths. Far from slowing down the march at the FDA to lower the bar for biopharma, Congress is intent on hitting the gas and forcing regulators to go even faster.


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RAPS Regulatory Convergence 2017