One hundred days into the new administration in the United States, we have more questions than answers about how healthcare policy and regulation will proceed for the next four years.
In our February webinar, Stirred and Shaken: How a New Administration Will Change the U.S. Healthcare Market, we discussed likely impacts on the FDA and the National Institutes of Health as well as the Inflation Reduction Act and the Affordable Care Act. We looked at potential coverage shifts which may now be coming into focus as Congressional Republicans weigh possible cuts to Medicaid spending and the Affordable Care Act exchanges. In last week’s webinar, Navigating Potential Disruptions at the U.S. National Institutes of Health, our panel talked about the impact of layoffs and grant cuts at that critical funder of biopharmaceutical research and how researchers, institutions and innovator companies can weather the storm.
Massive disruption to medical research
A particular focus of the administration’s efforts to identify waste, fraud and abuse has been the National Institutes of Health, which has seen more than $2 billion in federal research grants canceled and 1,300 employees laid off.
Earlier this month, the administration announced that the NIH would cut off grants to international research partners in U.S.-led consortia effective immediately, citing national security reasons, and unveiled a proposed $18 billion, or 26%, budget cut for 2026, citing the COVID-19 lab leak theory and “radical gender ideology.” Under the administration’s proposed budget, funding would be eliminated for the National Institute on Minority and Health Disparities, the Fogarty International Center, the National Center for Complementary and Integrative Health, and the National Institute of Nursing Research. It proposes consolidating, quote, “multiple overlapping and ill-focused programs into five new focus areas with associated spending reforms.” It says “NIH research would align with the President’s priorities to reduce chronic disease and other epidemics, implementing all executive orders and eliminating research on climate change, radical gender ideology and divisive radicalism.”
Last week, the administration announced layoffs of 250 more employees, including 50 from the National Cancer Institute. That comes on top of the layoffs announced in March (though Secretary of Health and Human Services Robert F. Kennedy, Jr. said a fifth of those layoffs were made in error). Stat News reports that some clinical trials are months behind schedule as a result of the disruption. According to their analysis, NIH grant awards fell by $2.3 billion in the first few months of the new administration. Amid all this uncertainty, companies are paring back programs tied to federal dollars and exercising greater caution in their investments, partnerships, mergers and acquisitions while they wait for the dust to settle.
What it means for medical science
In science, said Principal, Pricing and U.S. Market Access Consulting at Clarivate Moira Ringo, “Everything depends on everything else and disruption, even to early discovery, affects everything downstream.” Downsizings at NIH and FDA could augur funding headaches for researchers, snags for companies seeking approvals and even possible pipeline gaps for pharmas.
So how can researchers and companies mitigate the disruptions of this chaotic moment in Washington?
- Identify areas of convergence. Whether writing a grant for a research program or exploring a partnership, consider how your aims align to those of the other party. “You can’t pivot, but try to see how you might align and put forward strong proposals,” said Dr. Hernan Bazan, vascular surgeon and CEO of South Rampart Pharma, which is developing novel non-opioid alternatives for pain relief.
- Plan for every imaginable contingency. An unpredictable environment such as this calls for even more rigorous prep work and a thorough understanding of the business, scientific and regulatory landscape. “Nothing is off the table,” said Ringo. Figure out what your greatest risks are and manage those. We do our work but we plan.”
- Think beyond your lane and across silos. New models of funding, researching and commercializing medicines will be needed in this new world. “Embrace the fluidity between medicine, bioscience and finance,” said Anette Breindl, Managing Editor of BioWorld Science.
View the full webinars on the election impact and the NIH cuts for more information on these topics, and visit BioWorld for the most in-depth and up-to-date coverage of the Trump Administration’s healthcare policies.
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