FDA & CDC Turmoil: Mass Layoffs, Purges, Resignations, Policy U-turns & Low Morale

The entire federal medical oversight and guidance system is in crisis. President Trump has often promoted “biomedical innovation” and promised to make the U.S. a leader in the field. However, the approval process for new drugs has significantly slowed due to lack of federal agency staffing. Biotech research companies complain that they invest billions into researching new drugs so they want clear guidelines and requirements of the process, but the goalposts are constantly changing and infighting among federal leaders makes even predicting any new requirements nearly impossible. John Crowley, CEO of the industry advocacy group Biotechnology Innovation Organization, told reporters that the “constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.” Clay Alspach, executive director of the Alliance for mRNA Medicines said, “Abrupt shifts in vaccine policy—introduced without transparent, evidence-based deliberation—risk undermining the rigorous framework that has long guided vaccine development and approval.” Alspach said that any changes of such large proportions should be made in an open and public process. Alspach concluded, “When a dozen former FDA commissioners from across the political spectrum—including those who served during President Trump’s first term—warn of a threat to public health, everyone should stop and take notice.”