Biotech industry backs FDA hiring push, seeks science-led drug reviews

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Biotech supports FDA hiring

Highlights

FDA plans to fill 2,200 open positions and accelerate cell and gene therapy development following over 3,000 staff cuts and frequent leadership turnover.
Industry leaders urge FDA to rebuild scientific expertise and standardize review processes amid leadership instability, with six main drug-review arm heads since January 2025.
U.S. faces pressure to quicken drug approvals as China overtakes in clinical-trial volume, while investors stress the need for predictable, science-led FDA reviews.

FDA rebuilding plan faces industry scrutiny

As reported by Reuters, the FDA has announced since early June that it plans to fill 2,200 open positions, shorten clinical trial timelines and speed development of cell and gene therapies as it tries to restore capacity after significant staff cuts.

Under Robert F. Kennedy Jr., President Donald Trump's health secretary, the agency has lost more than 3,000 employees through cuts and departures, including key division heads. The FDA's main drug-review arm has had six different leaders since January 2025, when Trump began his second term, and it is now led by a temporary director.

John Guy, policy director at the Incubate Coalition, said regulatory predictability is essential to keep promising science moving toward patients and that the agency should prioritize rebuilding durable scientific expertise. John Crowley, CEO of biotechnology trade group BIO, described the cuts as the "DOGE wrecking ball" and said the FDA needs to do more to standardize review processes.

Former officials have also raised concerns about politics at the regulator. Long-time FDA cancer division head Richard Pazdur and others have said key decisions on drugs and vaccines have become too political, while former Commissioner Marty Makary resigned in May and biologics division chief Vinay Prasad left in April amid controversy over vaccine trial revisions and rare-disease drug rejections.

Leadership uncertainty and competitive pressure

The administration appears to be considering three candidates for Trump to nominate as FDA commissioner, according to two sources familiar with the process who spoke on condition of anonymity. They are White House domestic policy aide Heidi Overton, oncologist Jeffrey Vacirca and Pentagon health official Stephen Ferrara, while the White House did not immediately respond to a request for comment.

Pressure to move faster also reflects global competition, especially from China, which has surpassed the United States in clinical-trial volume. Paul Hastings, CEO of South San Francisco-based Nkarta, said the FDA is highly focused on cell therapy and that the U.S. wants to maintain its lead in the field.

The FDA is still widely viewed as the global gold standard for assessing drug safety and effectiveness, and it has so far maintained its pace of approvals. Still, industry participants say investor confidence depends on a stable, science-led review system, even as some companies such as cell-therapy developer Kyverna say the agency's upheaval has not directly disrupted their operations.

Our earlier article on the planned U.S. tariffs on imported generic drugs explained how the Trump administration aims to push manufacturers to move production onshore by imposing steep duties starting in 2028. It also highlighted proposed country- and company-specific carve-outs, and the industry’s push for clarity amid concerns about maintaining reliable access to affordable medicines.

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