Politicisation of the US FDA: eroding integrity and trust
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Published March 28, 2026
DOI: 10.1016/S0140-6736(26)00600-8 External LinkAlso available on ScienceDirect External Link
Copyright: © 2026 Published by Elsevier Ltd.
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OkThe principle that medicines should not reach patients without strong safety guardrails forms the bedrock of the US Food and Drug Administration (FDA). The FDA shapes decisions about which medicines reach consumers around the world, through robust standards for safety, efficacy, and post-marketing oversight in drug regulatory practices, with a 2026 budget of $6·8 billion. It faces a tough balancing act in maintaining scientific standards and rigorous review while bringing medicines and devices to the patients who need them as quickly as possible. Because of this tension, and the power of its decision making, the FDA's political independence has been under scrutiny since its inception. Although speed is important, transparency and integrity ensure safety and public trust.
Under the Trump administration, the FDA is quickly losing its capacity due to increasing strain. In 2025, nearly 90% of senior FDA leaders were reported to have left, leaving only three experienced senior managers. With federal cuts and resignations, the FDA workforce fell by nearly one-quarter—more than 4000 people. Fewer staff have led to delayed reviews, postponed inspections, and heavier workloads. Since January, 2025, the Center for Biologics Evaluation and Research—the part of the FDA established to accelerate vaccines, gene therapies, and other drugs for rare diseases—has had six different directors. Recently departed staff have raised concerns that political appointees are exerting influence over scientific and regulatory decisions.
In July, 2025, Marty Makary, the FDA Commissioner, made commitments to modernise the agency by “embracing gold-standard science, radical transparency, and common sense”. But inconsistent decision making has occurred in several high-profile drug reviews. In February, the FDA refused to review the biologics licence application for mRNA-1010, Moderna's mRNA influenza vaccine, because the agency objected to the trial design —rather than a safety or efficacy issue—despite previously signing off on the study, according to reports. 1 week later, it reversed its decision and agreed to review an amended application. The new Rare Disease Innovation Hub, which includes a framework to allow some drug approvals without randomised controlled trials, has demonstrated some high-profile successes alongside several setbacks in Friedreich's ataxia, Angelman syndrome, and Hunter syndrome. The FDA's rejection of a gene therapy for Huntington's disease also seems to have fallen prey to inconsistent evidence standards. Transparency is not only about releasing documents but also requires scientific reasoning and regulatory decisions that are clear, understandable, and consistent.
Perhaps most seriously, a regulatory agency cannot function effectively while its scientific processes and staff are bypassed and its independence is compromised. The pilot National Priority Review Voucher Program (CNPV) aimed to drastically reduce review timelines for applications from the usual 10–12 months to 1–2 months for products addressing urgent public health or medical needs. This is an admirable target, but the scheme has been criticised for relying on discretionary selection by agency leadership rather than a formal competitive process to award the vouchers. CNPV awards for fertility and obesity drugs have been linked to the Trump administration's negotiated pricing or access commitments. At least five companies that participated in Medicare price negotiations with the White House between 2023 and 2026 also received FDA vouchers in 2025 or 2026. This deepens the concern that regulatory tools are being used to advance a political agenda.
Direct political intervention has aimed to override FDA scientific review in the past. Eventually approved for early pregnancy termination, mifepristone was subject to three decades of intense political interference. While Congress took measures to block approval, White House directives promoted it. Drug approval became a battleground for national politics and the lines between scientific regulation and politics were blurred. Health outcomes suffer when political interference weakens public trust in FDA decisions, distorts risks relative to benefits, and delays access to products that address medical needs.
Confidence in the FDA's scientific strength is central to its legitimacy. Even the perception of political influence in scientific decision making can damage trust. Although the administration rightly shapes overall regulatory priorities, politics must be kept out of case-by-case regulatory decisions. An FDA subject to intervention by politicians loses the trust of the public, industry, and the medical community. When that happens, the consequences are not administrative—the losses can be counted in human lives.