Is the White House Budget at Odds With NIH's Contributions to New Drugs?

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. Under the proposed plan, the National Institutes of Health (NIH) budget for 2019 would remain about equal to its 2017 budget: $34.8 billion. However, this figure would be roughly $2 billion less than the 2018 budget that was just approved by Congress on February 8.

Within the proposed budget, the White House calls for the creation of a National Institute for Research on Safety and Quality (replacing the Agency for Healthcare Research and Quality under HHS); the transfer of the National Institute of Disability, Independent Living, and Rehabilitation Research from HHS to the NIH; and the transfer of the National Institute of Occupational Safety from the NIH to the Centers for Disease Control. The plan would also provide the NIH with an additional $750 million for research on the opioid crisis, of which $400 million must be spent on public-private partnerships.

On the same day that Trump put forward his budget proposal, the Proceedings of the National Academy of Sciences of the United States of America (PNAS) released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

The report’s authors identified NIH-funded publications and projects that were directly related to each of the 210 new molecular entities (NMEs) (or their molecular targets) approved by the FDA over the timespan of 2010 to 2016. The NIH research comprised more than 200,000 funding years and project costs that totaled more than $100 billion. The analysis suggests that as much as 20% of the NIH budget allocation from 2000 to 2016 was associated with research that directly or indirectly contributed to the NMEs approved between 2010 and 2016.

“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),” noted the authors, who added that “This work shows that a large fraction of the NIH research budget is focused on the basic research required to bring new products to market. Any reduction in this funding that slows the pace of this research could significantly delay the emergence of new drugs in the future."

Reference:

Cleary EG, Beierlein JM, Khanuja NS, McNamee LM, Ledley FD. Contribution of NIH funding to new drug approvals 2010-2016. Proc Natl Acad Sci USA. https://doi.org/10.1073/pnas.1715368115. Published online February 12, 2018. Accessed February 13, 2018.