Inspectors tasked with ensuring the safety of America’s drug supply are reeling from deep cuts at the Food and Drug Administration (FDA), despite promises to preserve their work by the Trump administration. Dozens of staff members who helped coordinate travel for complex inspections of foreign factories have been let go, leaving inspectors struggling to keep up.
The FDA has faced criticism over its handling of safety issues with medications made in countries such as India and China. Inspectors have uncovered dirty equipment, contaminated supplies, and fraudulent testing records at some overseas factories, posing serious risks to consumers. The agency’s Center for Drug Evaluation and Research had previously reported that a generic immunosuppression drug could dissolve too quickly when ingested, increasing the risk of kidney failure.
The Trump administration announced plans to lay off over 3,500 FDA employees in April, citing a need to reduce “bureaucratic sprawl.” However, inspectors say that the cuts have had a devastating impact on their work. Nearly 70 people who helped arrange travel, budgets, and contingency plans for investigations were let go, with only about one-third being reinstated.
Inspection units are now struggling to investigate potential safety issues due to a lack of support staff. Inspectors often spend weeks traveling to overseas factories, dealing with complex logistics and language barriers. The agency’s investigative unit has faced a retention problem, with many experienced investigators leaving the organization.
The FDA needs an additional 100-200 experienced inspectors to do its job properly. With over 1 million reports of product quality issues or adverse reactions in 2023, it is clear that the agency cannot afford to lose more staff. Former FDA Commissioner Margaret Hamburg warned that the layoffs will lead to “a lot less safe drugs.”
The Trump administration’s response to the layoffs has been criticized as inadequate. Despite announcing plans to reinstate some employees, no details have been provided on how many people will be brought back or whether additional support staff will be hired. The agency’s efforts to expand unannounced inspections and use AI tools to identify targets are seen by many as insufficient to address the staffing shortages.
Source: https://www.propublica.org/article/fda-cuts-drug-factory-inspections