The Trump administration arrived at the swamp with a mission: return power to the people and away from the bureaucrats.
But some of the swamp survives. Inside the Food and Drug Administration (FDA), a left-leaning network called Arnold Ventures was tacitly undermining President Trump’s promise to put patients first. Their most influential partners were FDA Commissioner Dr. Marty Makary and CBER Director Dr. Vinay Prasad, who made decisions that put life-saving treatments for children with terminal rare diseases dead last.
A liberal network embedded in a conservative administration
Arnold Ventures is a Houston-based billionaire-backed nonprofit calling itself a champion of “evidence-based policy.” In practice, critics argue that the phrase describes a regulatory philosophy that has a reputation for prioritizing cost containment over patient access (money over people); embracing Europe’s more restrictive drug approval frameworks (less innovation and access) and — based on the actions of Makary and Prasad — views America’s biotech pipeline as a problem to be slowed rather than a resource to be unleashed (patients suffer more from diseases that could be slowed or reversed).
Arnold’s financial footprint inside the FDA has been extensive. Prasad received at least $2M (with online researchers noting that it may be twice that) in Arnold Ventures grants over his academic career.
Makary received nearly $700,000. Katherine Szarama, a clinical trials director at Arnold Ventures, was appointed CBER deputy director in October 2025 — and when Prasad departed, she replaced him as acting director.
Arnold Ventures representatives remained on the FDA’s public calendar as recently as March 3, 2026, as “Collaboration Opportunities.” — a week after Senators used a Senate Special Committee on Aging hearing to express concerns about the FDA’s handling of rare diseases.
Although Makary, Prasad, and Szarama have since stepped aside, the question remains whether Arnold Ventures’ influence is still present in the halls of the FDA.
The human cost of ideology
Under Arnold Ventures-affiliated FDA leaders, CBER rejected cell and gene therapies experts believe would have been cleared in the past, including treatments for Huntington’s disease, Duchenne muscular dystrophy, Hunter syndrome, and advanced melanoma. In some cases, the agency reversed written agreements with sponsors without documented rationale.
The scandal lid blew last summer when the FDA restricted Sarepta’s Elevidys — a gene therapy showing measurable improvements in muscle function for Duchenne patients — after claiming the drug was responsible for three patients’ deaths.
After months of wrangling, the FDA finally approved Elevidys for ambulatory children while revoking access for non-ambulatory patients. Kids closest to death — who need help the most — were blocked from receiving the only gene therapy on the market.
For a time, patient advocates thought this partial victory was a sign that times were changing at the FDA. Instead, Arnold Ventures ideology struck again, this time in March 2026, when a senior FDA official called uniQure’s AMT-130 — a gene therapy that slowed Huntington’s disease progression by 75% in trials — a “failure,” triggering the treatment’s formal rejection.
The FDA then demanded a full Phase 3 trial, requiring control-group participants to undergo a sham brain-injection procedure. Senator Ron Johnson (R-Wis.) called it “bureaucratic idiocy.”
Dr. Prasad gutted the structural check that might have questioned these rejections. FDA Advisory Committees (AdComms) — panels of outside experts who evaluate drug applications in public forums — were sidelined throughout Prasad’s tenure, overridden more frequently than in any recent period. Closed-door decisions that seemed to align with Arnold Venture influence replaced transparent deliberation, with no public record or appeal.
Two resignations don’t fix an occupation
Republicans and Democrats alike have expressed concern about FDA policies under the Arnold-affiliated appointees. A White House announcement is expected any day on new FDA leadership for both the Commissioner and the director of FDA’s treatment approval arm, CBER (Center for Biologics Evaluation and Research)
After that announcement, the Senate Health, Education, Labor, and Pensions Committee, led by Sen. Bill Cassidy (R-La.) — himself a physician — will be responsible for vetting and voting on FDA appointees. This is a tremendous opportunity for Senator Cassidy to make a lasting and positive impact for American patients by making sure his committee asks tough questions to confirm there are no Arnold Ventures relationships among new leaders.
Appointees must affirm that patients come first — especially those with rare diseases who do not have the luxury of time to wait for endless delays. FDA leadership must be aligned with Trump administration “right to try” and “patients first” policies and not Arnold Ventures’ non-patient-centered worldview.
For these critical appointment decisions, just having a medical background is not enough. Leaders must have the scientific and humanitarian outlook that puts patients first regardless of age, disease population, or ultimate life expectancy.
What this administration still owes rare disease families
Families of loved ones with Duchenne, Huntington’s, and Sanfilippo showed up to Senate hearings in February 2026 in wheelchairs and in tears — and with nothing left to lose. Senators, patient advocates, and the scientific community gave them full support, and interestingly, Makary and Prasad were gone within weeks.
Arnold Ventures-aligned FDA staff were not rogue actors. They were recruited, funded, and positioned over the years to execute a regulatory vision that was never compatible with this administration’s promises.
The FDA’s key players are changing, and the culture must change with them.
The next FDA commissioner must reflect a cultural change away from backroom ideological interference. The swamp knows how to wait. The administration needs to make sure it doesn’t get the chance.
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