Biotech Experts Demand FDA Drug Reviews Based on Science, Not Politics Amid Leadership Turmoil
核心洞察
Biotech industry leaders are calling for the FDA to ensure drug reviews remain grounded in scientific expertise rather than political influence following significant leadership turnover.
The FDA has lost more than 3,000 employees under the Trump administration, with the main drug-review arm cycling through six different leaders since January 2025.
Former FDA Commissioner Scott Gottlieb urged reinstating the standard that medical product centers be led by experienced scientific and clinical experts in a JAMA editorial.
Biotech experts and industry executives are calling plans by the U.S. Food and Drug Administration to hire thousands of employees and update clinical-trial standards encouraging, but they want assurance that politics will not interfere in the agency's drug-review process. The FDA, long viewed as the global gold standard for assessing drug safety and effectiveness, has experienced significant upheaval under the Trump administration, including the loss of more than 3,000 employees through cuts and departures.
"Regulatory predictability is ultimately what keeps promising science from being abandoned before it reaches patients," said John Guy, policy director at the Incubate Coalition, a venture capital advocacy group. "The agency's current priority should be rebuilding durable scientific expertise."
Leadership Instability and Political Interference Concerns
The FDA's main drug-review arm has had six different leaders since January 2025, when President Donald Trump began his second term, and is currently led by a temporary director. Former Commissioner Marty Makary resigned in May amid mounting criticism, while biologics division chief Vinay Prasad departed in April amid controversy over vaccine trial revisions and rare-disease drug rejections.
John Crowley, CEO of the BIO industry trade group, described the workforce reductions as the "DOGE wrecking ball," referring to the Trump administration's Department of Government Efficiency, initially spearheaded by billionaire Elon Musk. Crowley added that the FDA needs to do more to standardize review processes.
Long-time FDA cancer division head Richard Pazdur and other former agency officials have in recent months characterized the regulator as too political, with key decisions on drugs and vaccines being made by then-Commissioner Makary or his department heads rather than through established scientific review channels.
Rebuilding Scientific Expertise
Since early June, the FDA has announced plans to fill 2,200 open positions, shorten clinical trial timelines, and speed development of cell and gene therapies. Some policy changes are being driven by global competition, including from China, which has outstripped the United States in clinical-trial volume.
"The one thing the FDA is very focused on is cell therapy," said Paul Hastings, CEO of South San Francisco-based biotech company Nkarta. "We are in the lead, and want to keep that lead."
The FDA has so far been able to maintain its pace of drug approvals, "but investors are watching closely," Guy noted.
Calls for Restoring Scientific Boundaries
Former FDA Commissioner Scott Gottlieb, writing in an editorial last month in the medical journal JAMA, stated that the exits of Makary and Prasad present an opportunity to consider FDA leadership needs and "where the boundary lies between political power and scientific judgment." Gottlieb called for reinstating the "overarching standard" that FDA medical product centers be led by experienced scientific and clinical experts.
Emily Hilliard, a Department of Health and Human Services spokesperson, pushed back on these characterizations, stating in an email that "suggesting that the agency's regulatory actions reflect politics rather than science misrepresents the FDA's review process and the hard work of its dedicated career scientists, physicians and other experts."
Controversial Decisions Under Scrutiny
Among the decisions drawing criticism was Prasad's initial refusal to review Moderna's mRNA flu vaccine (搜索). Health Secretary Robert F. Kennedy Jr., long known for anti-vaccine views, has criticized mRNA vaccines and cut their U.S. government research funding. Prasad later reversed course and accepted the application after Moderna, according to media reports, took the issue directly to the White House.
Makary's public criticism of an application for a Huntington's disease (搜索) treatment, believed to be a gene therapy from Netherlands-headquartered UniQure, further fueled perceptions that drugmakers and patients were being treated unfairly.
"We can get better by innovating not just in technology, but in how we evaluate ... how we standardize criteria for FDA review," said Paul Wotton of RBL Ventures, a Houston-based biotech venture creation studio.
Industry Impact and Future Outlook
Upheaval at the agency has not affected Emeryville, California-based cell-therapy developer Kyverna (搜索), said CEO Warner Biddle, although "it did call into question a pathway forward for some of these therapies."
Elizabeth Jungman, global regulatory attorney at law firm Hogan Lovells and former chief of staff to the FDA commissioner, said the traditional barrier between FDA leadership and drug reviews was "perforated," and it remains to be seen whether the role of the FDA's scientific staff will be fully restored.
"It's entirely possible that we are in the eye of the storm right now," Jungman said.
The administration appears to be focused on three candidates for Trump to nominate as FDA commissioner: White House domestic policy aide Heidi Overton, oncologist Jeffrey Vacirca, and Pentagon health official Stephen Ferrara, according to two sources familiar with the process who spoke on condition of anonymity. The White House did not immediately respond to a request for comment.