Biotech Leaders Urge FDA to Prioritize Science Over Politics Amid Staffing Crisis

Biotechnology industry executives and policy experts are calling for the U.S. Food and Drug Administration to insulate its drug review process from political influence, following a period of significant staff departures and leadership instability that has raised concerns among investors and drug developers.

Agency in Turmoil

The FDA has been hit by a wave of job cuts and high-level departures, losing more than 3,000 employees under the Trump administration, according to a Reuters report. The agency's main drug-review arm has had six different leaders since January 2025, and former Commissioner Marty Makary and biologics division chief Vinay Prasad both resigned this spring amid criticism.

John Crowley, CEO of the BIO industry trade group, attributed the staffing crisis to the administration's Department of Government Efficiency (DOGE), calling it a "wrecking ball." The instability has created a challenging environment for an agency long considered the global standard for drug assessment.

Calls for Scientific Integrity

Industry advocates argue that this upheaval threatens the predictability essential for long-term drug development and investment. "Regulatory predictability is ultimately what keeps promising science from being abandoned before it reaches patients," John Guy, policy director at the Incubate Coalition, told Reuters.

Concerns over political interference were fueled by several incidents, including an initial refusal to review Moderna’s mRNA flu vaccine and public criticism by then-Commissioner Makary of a Huntington’s disease gene therapy application. Former FDA Commissioner Scott Gottlieb, writing in the medical journal JAMA, called the departures an opportunity to reconsider "where the boundary lies between political power and scientific judgment."

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Market and Investor Implications

While the FDA has so far maintained its pace of drug approvals, the ongoing uncertainty is a key concern for the biotech sector. "Investors are watching closely," Guy noted. The situation is amplified by growing global competition, particularly from China, which has reportedly surpassed the U.S. in clinical-trial volume.

Maintaining a competitive edge in innovative fields like cell and gene therapy is a priority for U.S. companies. "The one thing the FDA is very focused on is cell therapy," said Paul Hastings, CEO of Nkarta. "We are in the lead, and want to keep that lead."

Path Forward

In response to the crisis, the FDA announced plans in June to fill 2,200 open positions and implement measures to speed the development of cell and gene therapies. However, the agency's top leadership position remains vacant as the White House reportedly considers three candidates for the role.

For the industry, the critical question is whether new leadership can restore the traditional separation between the agency's scientific staff and political appointees. Elizabeth Jungman, a former FDA chief of staff, told Reuters the barrier was "perforated," and it remains to be seen if the scientific staff's role will be fully restored.