The Department of Health and Human Services is preparing to create two new deputy commissioner positions at the Food and Drug Administration -- one focused on technology and the intersection of health with artificial intelligence, the other on drugs -- according to two sources who spoke to CNBC on condition of anonymity. [1]
Both roles would report to Heidi Overton, Trump's pick to lead the FDA, who still awaits Senate confirmation. The agency already has several deputy commissioners, including an acting deputy commissioner for food whose permanent successor remains unnamed. HHS officials view the new positions, according to CNBC's sources, as a way to exert greater influence over an agency that has increasingly clashed with the industry it regulates. No final decisions have been announced. [1]
One clash a new deputy commissioner for drugs would inherit sits mostly outside this week's coverage: the FDA's unresolved fight with the biotech company uniQure over how to test a Huntington's disease gene therapy. The FDA has told uniQure it will not accept the company's Phase 1/2 trial data, which showed the therapy slowed disease progression by 75 percent against external controls, as sufficient for approval without a randomized, sham-controlled study. [2]
The dispute over what that sham procedure would actually require has been unusually granular and unusually public. UniQure's chief medical officer said in March that a legitimate sham-controlled arm would require anesthetizing Huntington's patients for up to 12 hours and drilling a superficial hole in the skull -- risks he called difficult to justify in a fatal, progressive disease with no approved disease-modifying treatment. An unnamed senior FDA official pushed back days later, telling reporters the agency never asked for a partial burr hole at all, only that patients be anesthetized and receive "one to three nicks in the scalp." [2]
The underlying regulatory question has not gone away. UniQure maintains the FDA reversed course on guidance it had previously accepted; the FDA maintains it has required internal controls "for at least two decades" and never promised otherwise. [2] Patients and advocacy groups, including families who have lost relatives to Huntington's, have pressed the agency publicly to reconsider, arguing every year of delay costs lives in a disease that only worsens.
That fight -- over what counts as an ethical placebo when the alternative is watching a fatal disease progress unchecked -- is exactly the kind of dispute a new deputy commissioner for drugs would be positioned to referee. CNBC's report on the leadership reshuffle treats it as an internal-control story: who reports to whom, and whether HHS is centralizing power at the FDA. It does not connect the new title to the specific fights over trial design already testing whether the agency's current leadership will bend for cases like uniQure's.
Whoever fills the role inherits that fight regardless of whether this week's coverage mentions it. The uniQure standoff has already run for the better part of a year without resolution, and a newly created deputy commissioner arriving with a broad mandate to reassert HHS control over the agency gives patients and industry alike a fresh, unproven variable to watch.
-- NORA WHITFIELD, Chicago