President Donald Trump’s first budget has not gone down well with the medical research and regulatory communities, which have come out against his plans to cut nearly $6 billion from the NIH and possibly double FDA user fees.
ASCO, which represents 40,000 cancer docs and health professionals and runs the largest cancer research conference of the year, said starkly: “[The] President’s budget will devastate U.S. research enterprise.”
It went on: “We soundly oppose President Trump’s budget outline, which would cut $6 billion from the National Institutes of Health (NIH). Reducing NIH’s funding by nearly 20% will devastate our nation’s already fragile federal research infrastructure and undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis, and treatment.”
It said that the U.S. can’t afford to “turn back the clock on research” in oncology, and that “gutting the U.S. research infrastructure won’t make America First, but will decidedly place the United States behind other countries in scientific advances.”
ASCO says it is urging Congress, which does not have to implement the budget in its current state, to reject the proposed cuts and increase federal support for NIH, as well as the National Cancer Institute.
The NIH helps fund early-stage and translational research work in academia and with biotechs, and has a major reach around the U.S. and within the medical research community.
Gary Gilliland, president and director of the Fred Hutchinson Cancer Research Center in Seattle, which received more NIH funding in 2017 than any other cancer center in the country, told the LA Times: “We are at an inflection point in our efforts to develop cures for cancer and related diseases.” He called the proposed cuts “indefensible” and warned that they “would severely impede our progress.”
And J. Craig Venter, CEO of the J. Craig Venter Institute in La Jolla, California, and executive chair and founder of biotech Human Longevity, told the newspaper: “This is an engine that drives our entire economy. Our federal money can be better spent. But cutting these budgets will only make it 10 times worse.”
Venter said the NIH cuts will be akin to a biotech cutting its own research pipeline to save costs: In the end, it just removes high-risk research projects, but also removes their potential.
“The ones that suffer most are new investigators with new ideas,” he said. “It’ll just be a disaster for the U.S. economy.”
In a response to questions from Forbes, the pharma research lobby group PhRMA gave a standard, dry reply to questions on the issue of the NIH cuts, saying it would continue to review the budget and work with Trump to make the industry strong.
This drew much ire on Twitter when the response was posted by Forbes’ Matthew Herper, with industry vet and upstart Arrakis CEO Michael Gilman saying on PhRMA: “Those people are truly useless,” followed by: “Note to @PhRMA. Stay off Twitter for the next couple of hours.”
And on top of the cuts, the budget is also looking to cut back on spending at the FDA and relying more on increased user fees from the med dev and biopharma industry.
The budget plans state that it wants user fees to be more than $2 billion next year, which is around $1 billion over this year’s level.
It says the payoff will be allowing new meds to be sped through the FDA, but details here (and outside of the remit of Cures) have not yet been laid out.
“In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share,” the White House said yesterday.
The Alliance for a Stronger FDA was unequivocal in its response: “The President’s proposed funding mechanism—cutting more than a third of the agency’s appropriation and offsetting it with an enormous increase in medical product industry user fees—is neither wise nor realistic.
“Not wise because FDA’s core responsibilities—safe and effective medical products and safe foods—need to be supported in large measure by the public, who is the primary beneficiary. Not realistic because the drug and device industries have recently completed user fee agreement negotiations with FDA, concurring upon an appropriate amount of industry fees to support agency improvements. User fees have always been intended to supplement the agency’s appropriation, never to replace it.”
BIO, meanwhile, said: “While we are still reviewing today’s budget blueprint, we have initial concerns with the proposed reductions in the budgets for biomedical research, public health, and for agencies that play an important role in promoting innovations in agricultural, environmental, and human health.
“We are encouraged by other language in the budget blueprint that seeks to improve the regulatory environment for such innovations. As regards to user fee programs, we look forward to working with the President and Congress to preserve the commitments reflected in the carefully negotiated PDUFA VI goals letter, and ensuring that this vital program is reauthorized in a timely manner. We look forward to learning more about the President’s proposals to improve the FDA’s ability to perform its essential public health mission.”
Many biotech and medical device companies saw their stock drop on the budget yesterday, with the Nasdaq Biotechnology Index down 1.27%, and the S&P Biotech down 1.19%.