Donald Trump’s healthcare budget outlines FDA, NIH cuts

Donald Trump's budget is seeking to cut back on billions of dollars in federal research funding, while asking biopharma to pay more for the FDA.

President Donald Trump’s administration has released a breakdown of its attempts to cut back on healthcare and research spending across the government, with proposed cuts to governmental biomedical research centers and the drugs regulator laid down in the fleshed-out budget.

The document (available via the Washington Post), "Putting America’s Health First: FY 2018 President’s Budget for HHS," sees the NIH in line for just under a 20% cut, down to $26 billion in FY 2018 from $31 billion in 2016, a loss of around $5.8 billion. The FDA meanwhile will be down $855 million in funding next fiscal year, but there are plans to increase FDA user fees to make up the shortfall, and more.

Funding for the Centers for Disease Control is also on the block, with under a billion dollars ($934 million) set to be spent on HIV/AIDS, viral hepatitis, sexually transmitted infections, and TB prevention, a drop in funding of around 17%.

Structural changes are also in the works for the NIH, aimed at reducing “indirect costs and preserve more funding for direct science.” It says the NIH has been split 70-30 in terms of spending on “direct science”, with 30% being spent on “indirect costs.”

The plans also outline the administration’s desire to cut the NIH’s Fogarty International Center, but will retain all federal staff and aims to “maintain key activities in other NIH Institutes.” The changes are designed to “enable NIH to focus on higher priority activities.”

The proposed budget is also seeking to consolidate the Agency for Healthcare Research and Quality into the NIH, but will hold on to its discretionary $272 million funding.

But as part of this, the NIH will be told to “conduct a review of health services research across NIH and develop a strategy to ensure the highest priority health services research is conducted and made available across the Federal Government.” The budget will also cut what is deemed “lower priority” programs.

And for the FDA, now run by Trump’s pick Scott Gottlieb, this budget is reworking how companies pay for the Agency’s premarket work: “Industry fees are increased 100% of costs for premarket review and approval activities,” it says.

The budget reiterated previously made points from the White House that in a “constrained environment,” life science companies “can and should pay to support FDA’s activities.”

The budget also says it will include reforms that “balance the demand for scientific rigor and access to reliable, lifesaving cures. In addition, the budget will include regulatory relief to the industry and speed the development of safe and effective medical products.”

This will dovetail with the recently approved 21st Century Cures Act, which also aims to help speed up approvals, alongside the Breakthrough and Fast-Track tags that are also handed out to biopharmas.

Former FDA Commissioner and Obama pick Robert Califf, speaking on Twitter, said of the cuts this week: “[This] must be dealt with vigorously just like NIH. A cut in FDA will create logjam for life cycle of technology innovation.”

In the document, released Monday, it sums up the reduced funding stream by saying: “The Department’s approach to budgeting this fiscal year puts the American people first by supporting fiscal discipline within the Federal Government and saving taxpayers a net estimated $665 billion over 10 years.” Around $250 billion of that is slated to come from reform to Obamacare.

This builds on the so-called skinny budget, released a few months back. But it’s not all slash and burn, as there are also healthcare investments planned, including a $207 million boost “to respond to the needs of the American people in the event of an influenza pandemic,” as well as over $1 billion into the R&D of “medical countermeasures needed during disasters,” such as “radiological, nuclear, chemical and biological threats.”

But the cuts are getting the most attention. 

Jonathan Hirsch, president and founder of precision medicine company Syapse, and who served on the White House Cancer Moonshot Data Sharing Working Group, told FierceBiotech in a statement: “Even if the Trump budget proposal never fully comes to fruition, as is likely, it will still make an impact—forcing NIH to stall programs that physicians and patients rely on. We stand at the precipice of major breakthroughs in areas like cancer research, and NIH is critical to moving those forward. Now is the time to double down on our commitment to end cancer, not take steps backward.”

Research!America’s president and CEO Mary Woolley also did not pull any punches. “The president’s proposed FY18 budget is an imbalanced, heavy-handed approach to bolstering national defense at the expense of other American priorities, including the research and innovation crucial to national security. 

“Instead of weakening our nation with this approach, we urge the 115th Congress to negotiate a bipartisan budget deal that will ensure that both defense and non-defense priorities are sufficiently funded. While labeled as ‘discretionary,’ research and innovation supported by the National Institutes of Health (NIH), National Science Foundation, Centers for Disease Control and Prevention and the Food and Drug Administration strengthen our nation’s security and economic prosperity. Consistently, surveys show how highly Americans rank securing better health and quality of life; the President’s blueprint is tone-deaf to that reality.

“Steep funding cuts for the federal health agencies are counterproductive at a time when innovative research is moving us closer to identifying solutions for rare diseases, new prevention strategies to protect Americans from deadly and costly conditions, advances in gene therapy, new technologies for understanding the brain, and treatments that harness the ability of our immune system to fight cancer.”