Dr. Marty Makary's resignation as head of the Food and Drug Administration (FDA) on Tuesday marks the latest leadership churn within the Department of Health and Human Services over the past 16 months. The essay posits that Makary, like others, discovered the difficulty of enacting systemic change from within regulatory bodies compared to criticizing them externally. The FDA is crucial for ensuring the safety of medications, food supply, and medical devices, but under his tenure, trust in the agency has plummeted among both the public and internal scientific staff.

Makary's departure leaves the FDA without a permanent leader, mirroring instability elsewhere; the Centers for Disease Control and Prevention (CDC) has lacked a permanent director for months, and there is currently no surgeon general. This period has seen the dismantling of parts of the U.S. public health system, characterized by staff dismissals, cuts to data and logistics funding, and shifting guidelines, consequences now visible during the ongoing hantavirus outbreak.

While Dr. Makary achieved some successes, such as leveraging AI for clinical trial monitoring, his leadership was also marked by inconsistency. Specific missteps included refusing and then reversing course on reviewing a new flu vaccine and introducing a rare-disease approval program vulnerable to political interference. The overall result has been an erosion of the agency’s prestige and capacity, leading to the departure of many high-integrity staff members who maintain public safety infrastructure. Successful reform requires understanding institutional resistance and a commitment to transparency, which the essay suggests was missing.

This broader public health crisis compounds issues revealed during the Covid-19 pandemic, showing institutions were unprepared for complex crises. The difficulty in moving large systems stems from decades of regulatory inertia and external influence, making leadership changes like Dr. Makary’s exit emblematic of a wider governance challenge.