The next time someone challenges the importance of NIH-funded research in drug development, you might want to point them to a new study that highlights the foundational role the Institutes plays in biopharma research.
The study — published in the Proceedings of the National Academy of Sciences — concludes that every one of the 210 new molecular entities approved by the FDA between 2010 and 2016 can source research back to NIH-funded work. That is especially important in figuring the public context of first-in-class work, where basic research played a significant role in the scientific understanding of the targets involved.
From the study by a team of researchers at Bentley University:
These data demonstrate that a sizable public-sector investment occurs before the approval of first-in-class NMEs, particularly those discovered using targeted discovery methods (including recombinant biologicals). The scale of this investment can be estimated from the costs associated with first-in-class NMEs approved in 2010–2016 and their molecular targets. These data suggest that the public-sector investment in research underlying each first-in-class drug is as high as $839 million, with 89% of this cost associated with target research and 11% of the cost associated with the first-in-class compound or follow-on compounds approved from 2010–2016….
Overall, this analysis suggests that as much as 20% of the NIH budget allocation from 2000–2016 (more than $100 billion) was associated with published research that directly or indirectly contributed to NMEs approved from 2010–2016.
The authors in particular wanted to expand the scope of their research to make sure they were accounting for NIH-funded studies that were essential to a drug target, which doesn’t always factor into the patents used to protect the commercial value of each drug — a standard that had been used in earlier attempts to highlight the role of the NIH in drug development.
No one at the NIH is likely to get any kickback from biopharma on this score. NIH funding has been under the gun under President Donald Trump, who’s been ready to sacrifice research spending in favor of other priorities. But the NIH budget has been saved by a bipartisan phalanx of elected officials in Congress who have rallied against the cuts. They’ll be back on the frontline of this debate now that Trump has submitted a new budget this week that calls on lawmakers to flatline spending at the Institutes.
Those defenders just got some fresh ammunition for the fights to come.
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