FDA watchers warn of 'chaos' inside agency, as regulatory delays, staff hemorrhaging risk America's health

At the CNBC Cures Summit in New York City on March 3, 2026, former FDA Commissioner Scott Gottlieb and former Republican Senator Rick Santorum warned of 'chaos' inside the Food and Drug Administration, as regulatory delays and significant staff reductions threaten to delay critical treatments for rare diseases despite President Trump's stated goals of accelerating innovative therapies. The criticism comes amid growing concern that the FDA's approach to rare disease treatments has become inconsistent and overly cautious, with pharmaceutical firms and patient advocates pointing to shifting standards that are preventing promising treatments from reaching patients who have few or no alternatives. Congressman Jake Auchincloss (D-MA) specifically criticized FDA Commissioner Marty Makary, accusing him of 'replacing standards of safety and efficacy with fear and favor' and undermining both patient confidence and innovators' ability to bring new treatments to market. The concerns are particularly acute given the significant staff reductions the FDA has experienced over the past two years, with major departures in the Center for Drug Evaluation and Research department. Gottlieb noted that the oncology review staff has shrunk from about 100 people to below 60, representing a 'palpable loss of qualified reviewers' who possess the experience needed to make complex decisions about rare disease treatments. This expertise loss is directly impacting approval decisions, as evidenced by the drop in accelerated approvals from 20 drugs in 2024 to just nine in 2025. The issue was further highlighted when UniQure's experimental gene therapy for Huntington's disease was rejected by the FDA, leaving approximately 41,000 Americans living with the disease without a potential treatment option. In response to these criticisms, Commissioner Makary has outlined a proposed new system for approving customized drugs and therapies for rare diseases, which would create a standardized pathway for treatments tested in small patient groups. However, former Senator Santorum accused the FDA leadership of 'regulating by press release' rather than through consistent application of standards, while Pfizer CEO Albert Bourla claimed that the current director of biologics and vaccines, Vinay Prasad, has been disregarding the advice of the FDA's own scientists. The growing tension between the FDA's stated goals and its actual practices has led some, like Congressman Auchincloss, to call for the immediate removal of both Makary and Prasad, suggesting that the administration needs to appoint individuals who can gain bipartisan support to restore confidence in the agency's ability to deliver on its mission.