Eye on FDA

The White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., released its highly anticipated strategy outlining a multi-agency approach focused on addressing childhood chronic disease. The strategy builds on the Commission’s inaugural health assessment, a report which examined the rising rates of childhood chronic diseases in the country and identified four primary drivers: poor diet due to consumption of ultra-processed foods (UPFs), exposure to environmental chemicals; increased technological use; and overmedicalization. To combat these challenges, the strategy released on September 9, 2025, outlines a four-prong approach which provides further insight into the areas the administration sees as key areas of MAHA going forward: advancing research, realigning incentives, increasing public awareness and fostering private sector collaborations.

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs released today are associated with applications for drugs and biologics submitted for approval between 2020 and 2024 that have since been approved by the agency.

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug Administration’s (FDA) final rule, Medical Devices; Laboratory Developed Tests (the LDT Rule).¹ The LDT Rule would have required laboratories offering LDTs to meet medical device requirements. The preamble to the LDT Rule provided a multi-stage phase out of FDA’s enforcement discretion policy, under which the first set of regulatory requirements would have been actively enforced beginning May 6. While many labs are breathing a sigh of relief after the publication of this order, questions remain as to how the agency will proceed and the broader implications for regulation of lab tests and in vitro diagnostics generally.