Experts: Cuts at FDA could jeopardize US standing in clinical research, product innovation

The staffing cuts at the US Food and Drug Administration (FDA) have created a climate of uncertainty surrounding clinical trials. As a result, many companies are considering the possibility of developing drugs in other countries. This situation is perceived by some as a "gift to China," which has been intensifying its efforts in the pharmaceutical space, according to Jeremy Levin, CEO of Ovid Therapeutics.

Levin and other representatives of the biotech community recently signed an open letter to President Donald Trump spearheaded by No Patient Left Behind, a network of biotechnology innovators, investors, and healthcare professionals advocating for access to medicines. Focus spoke with members of the group to discuss the implications of FDA cost-cutting on clinical research.

The open letter, which was dated 10 February, criticized the administration’s planned staffing and budget cuts. The next week, FDA fired of hundreds of its probationary workers across multiple centers, some of which were later called back to their jobs. The Office of Personnel Management has also telegraphed further staff cuts across the federal government in a recent memo instructing agency heads to prepare plans for broad cuts across their agencies. (RELATED: Firing of FDA probationary staff creates widespread uncertainty, Regulatory Focus 17 February 2025; FDA rehires some laid-off staff, though some fear lasting damage to trust, Regulatory Focus 24 February 2025)

The NPLB letter praised the US as “the undisputed global leader in medical product innovation thanks in no small part to the [FDA’s] scientific expertise and regulatory transparency.”

Shehnaaz Suliman, chief executive of ReCode Therapeutics, told Focus that “having an adequately resourced FDA is critical right now. While quantifying the immediate impact of any cuts will be apparent with time, they would likely result in fewer opportunities to interact with agency staff, delays in approvals and an inability to expedite reviews.”

Levin and other colleagues said the current climate of uncertainty at FDA is not boding well for attracting clinical research.

“Ultimately large cuts will impact our ability to move approvals quickly and patients could suffer. Our competitive edge could be eroded as other countries like China develop faster and more cost-effective approaches from the clinic. A fully functioning FDA is a core part of our competitive advantage in the US.”

Levin said that pharmaceutical companies generally develop a ten-year plan for new drugs. Increased uncertainty means that this development may take place elsewhere.

Levin stated that China has prioritized becoming a leader in the biotech sector. For the past three years, the government has “categorically asserted” that one of its key priorities is to be at the forefront of biomedical innovation by the year 2025.

China has streamlined its drug approval process and aims to be the largest producer of medicines by 2025. This development alone should be a “clarion call” for the US, said Levin.

Levin emphasized that the biotech sector must collaborate with the administration to raise awareness about how its decisions affect the FDA and industry. He warned that if the planned funding and staffing cutbacks are not reversed, it will slow down the agency's ability to approve new medicines and diminish its capacity to inspect facilities worldwide.

Levin also criticized the administration’s method and lack of a strategic plan for cost-cutting.

“Over the years, I have overseen cost reductions affecting tens of thousands of employees. I led Teva and have been involved with Bristol Myers Squibb and Novartis in situations requiring cost reductions.” He emphasized that these reductions are generally carried out with a “clear strategic plan.”

He added that “in a well-functioning business, you know exactly why you are doing [the cost cutting] and you explain it to your employees clearly.” If this isn't accomplished, highly trained individuals may leave due to a lack of understanding.

He also said that it was “puzzling” to him why industry staff who were paid by user fees were laid off in the first place.”

Gunnar Esiason, head of patient engagement at RA Capital’s venture group RA Ventures, and a cystic fibrosis survivor, agreed that the current uncertainty is not helping the biotech sector.
“I think the worst thing that can happen to any biotech company is increasing the uncertainty about the regulatory pathway,” he said.

No Patient Left Behind Open Letter

Experts: Cuts at FDA could jeopardize US standing in clinical research, product innovation

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