Unclear How FDA Commissioner Makary’s Departure Will Impact His Initiatives

InnovationHealthcareUnclear How FDA Commissioner Makary’s Departure Will Impact His InitiativesByJoshua P. Cohen,Senior Contributor.Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy.Follow AuthorMay 14, 2026, 07:47am EDT--:-- / --:--This voice experience is generated by AI. Learn more.This voice experience is generated by AI. Learn more.Dr. Marty Makary, Food and Drug Administration commissioner, announced his resignation on May 12, 2026. During his 13-month tenure at the agency, he pursued a wide variety of initiatives. Going forward, their status is unclear. (AP Photo/Mark Schiefelbein)Copyright 2026 The Associated Press. All rights reserved.Food and Drug Administration commissioner, Marty Makary, announced his resignation this week. During his tumultuous 13-month tenure at the agency, he pursued a wide variety of ambitious initiatives and regulatory changes, some more contentious than others. Going forward, their status under the next commissioner is unclear.Among the wide-ranging alterations in FDA policy the commissioner worked on were a series of measures aimed at increasing transparency, reducing regulatory red tape to accelerate drug development pathways and tackling chronic disease (prevention) in collaboration with the Make America Healthy Again movement. STAT News added that Makary initiated programs to reduce animal testing, phase out the use of certain chemical dyes in food, streamline biosimilar development and ease regulations of therapies for ultra-rare diseases.Makary prioritized shortening clinical trial timelines by expanding the allowance of single-study drug approvals. This meant accepting one robust clinical trial instead of two pivotal trials for a larger set of medicines than before. Traditionally, drugmakers usually must complete two separate, large-scale studies to demonstrate a new medication’s effectiveness and safety. Going forward, the FDA’s default posit...