Biotech experts want FDA drug reviews based on science, not politics

The exits of Makary and Prasad are an opportunity to consider FDA leadership needs and "where the boundary lies between political power and scientific judgment," former FDA Commissioner Scott Gottlieb wrote in an editorial last month in the medical journal JAMA. 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, said 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." Decisions by Trump administration political appointees at the FDA include Prasad's refusal to review Moderna's MRNA.O mRNA flu vaccine. Kennedy, long known for anti-vaccine views, has criticized mRNA vaccines, cutting 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. Other incidents like Makary's public criticism of an application for a Huntington's disease treatment, believed to be a gene therapy from Netherlands-headquartered UniQure UQ1.F, fueled the idea 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. Upheaval at the agency has not affected Emeryville, California-based cell-therapy developer Kyverna KYTX.O, 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 Cadwalader 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. 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, California-based biotech company Nkarta NKTX.O. "We are in the lead, and want to keep that lead." The FDA, long viewed as the global gold standard for assessing drug safety and effectiveness, so far has been able to maintain its pace of drug approvals, "but investors are watching closely," Guy said. The administration appears to be focused on three candidates for Trump to nominate as FDA commissioner, and is awaiting his final decision, according to two sources familiar with the process, speaking on condition of anonymity. They are White House domestic policy aide Heidi Overton, oncologist Jeffrey Vacirca and Pentagon health official Stephen Ferrara. The White House did not immediately respond to a request for comment. Biotech investors want regulatory predictability, and biotech experts and industry executives are calling plans by the U.S. Food and Drug Administration — hit by job cuts last year — to hire thousands of employees and update clinical-trial standards encouraging, but want assurance that politics will not interfere in the agency's drug-review process. "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." Under Robert F. Kennedy Jr., President Donald Trump's health secretary, the FDA has lost more than 3,000 employees, including key division heads, through cuts and departures. John Crowley, CEO of the BIO industry trade group, described the cuts as the "DOGE wrecking ball," referring to the Trump administration's Department of Government Efficiency, which was 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 in recent months have called the regulator too political, with key decisions on drugs and vaccines being made by then-Commissioner Marty Makary or his department heads. Makary resigned in May amid mounting criticism, and biologics division chief Vinay Prasad departed in April amid controversy over vaccine trial revisions and rare-disease drug rejections. The FDA's main drug-review arm has had six different leaders since January 2025, when Trump began his second term as president, and is also now led by a temporary director.

Biotech experts want FDA drug reviews based on science, not politics

Calls for less political interference

Hiring plans and clinical-trial changes

Industry calls for predictable FDA reviews

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