Trump’s first budget seeks to slash $6B from NIH, raise FDA user fees

The Trump administration is looking to make a series of cutbacks, but will boost substance abuse services and new funds for outbreaks

President Donald Trump’s first budget will take $5.8 billion away from the National Institutes of Health (NIH), around 20% of its total, with FDA user fees also set to rise as biopharmas should "pay for their share."

The budget cut to the NIH, the leading state-backed medical research body that had around $30 billion in funds last year, also comes as the Department of Energy's Office of Science is set to lose $900 million, which also comes out as a 20% burning of its $5 billion budget. This Office supports research for around 300 universities and 10 national labs.

This is according to the White House budget (called a "blueprint" and seemingly subject to change), obtained last night by WaPo and now live, and comes after Trump recently pledged in a speech to Congress to help stop more diseases.

But Trump also made it clear during his campaign in 2016 that he wanted to cut back on government spending (outside of the military, which is in line for a major boost), and also comes as he is pledging to try and lower drug prices, and potentially remove some regulatory hurdles from the FDA.

The NIH, in fact, got a funding boost just last year when the 21st Century Cures Act was passed, a law that allowed the Institute an extra $4.8 billion in funding over the next decade. Some Republicans had been unhappy about this boost, however.

WaPo said a major re-jig at the NIH was also on the cards: “The spending plan calls for a ‘major reorganization’ of the 27 NIH institutes and centers, though it [the blueprint] does not spell out the changes—with one exception. It would abolish the Fogarty International Center, a $69.1 million program dedicated to building partnerships between health research institutions in the United States and other countries.

“The plan also would fold into NIH the Agency for Healthcare Research and Quality, a free-standing agency within HHS devoted to fostering research evidence to improve health care’s quality, safety and accessibility.”

And the Department of Health and Human Services (HHS) would also receive just $69 billion under the President’s budget proposal, a reduction of 17.9%.

There was no direct mention of FDA cuts, but use fees are set to potentially double. The blueprint says it: "Recalibrates Food and Drug Administration (FDA) medical product user fees to over $2 billion in 2018, approximately $1 billion over the 2017 annualized CR level, and replaces the need for new budget authority to cover pre-market review costs. To complement the increase in medical product user fees, the Budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products.

"In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share." More details were not revealed in the document and there remain questions over exactly what the industry could end up paying, but all this comes as user fees will expire in the fall.

But there is set to be a $500 million substance-abuse services funding boost aimed at treating the growing opioid addiction epidemic, and there are plans for an “emergency fund” to help respond to disease outbreaks, although details on this were thin on the ground.

The proposed cuts to the NIH have irked some: “A $6 billion cut to [NIH] is unacceptable to the scientific community, and should be unacceptable to the American public as well,” said Benjamin Corb, public affairs director of the American Society for Biochemistry and Molecular Biology in Rockville, Maryland, in a statement to Science.

“President Donald Trump’s fiscal year 2018 spending plan erases years’ worth of bipartisan support for the NIH, and the American biomedical research enterprise which has long been the global leader for biomedical innovation.  Cuts this deep threaten America's ability to remain a leader. It is of grave concern to the research community that President Trump's budget proposal – which would fund the agency at a 15-year low – values investments in defense above all other federal expenditures.”

And according to SNL, Rep. Rosa DeLauro, D-Conn., said these cutbacks would “turn back the clock on lifesaving biomedical research that has the power to change lives.”

“With more than $25 billion in cuts for programs funded by the Departments of Labor, Health and Human Services and Education, the Trump administration will decimate and eliminate some of our nation's most critical programs that serve hardworking American families," DeLauro added.

Meanwhile, UsAgainstAlzheimer’s co-founder and chairman George Vradenburg said: “We are unalterably opposed with the deep cuts proposed to NIH and medical research programs, which would threaten to undo the years of gains made in the fight against Alzheimer’s.

"The most direct path to health care cost savings is investing in research to achieve treatments and cures. Bipartisan leadership in Congress has strongly supported this path, and we urge Congress to reject the Administration’s proposed cuts.” The group reminds Trump that Alzheimer’s researchers have said that the minimum level of annual funding to achieve the national goal of stopping Alzheimer’s by 2025 is $2 billion a year at NIH. 

In the end, however, the 2018 budget will be set by Congress, which can decide to not follow Trump's blueprint.