FDA ‘Overdue’ on 2,000 Drug Plant Inspections: AP

An Associated Press analysis of FDA records shows that agency inspectors have not returned to some 2,000 drug manufacturing firms to conduct surveillance inspections since before the 2019 Covid-19 pandemic. An AP report says the firms that are overdue for inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and underwent FDA review before 5/2019.

Most of the plants are in the U.S., the report says, but 340 are in China and India, countries that together are the largest source of ingredients used in generic U.S. prescriptions.

“Under FDA’s own guidelines,” AP says, “factories that haven’t been inspected in five or more years are considered to be a significant risk and are supposed to be prioritized for ‘mandatory’ inspections”

FDA associate commissioner Michael Rogers told the news service that “the U.S. drug supply is the safest on the planet and no other regulator conducts more inspections than FDA.” He also said that the agency has increased drug inspections each year since 2021, while prioritizing foreign factories.

AP says that last year’s inspection numbers were down almost 40% from the pre-pandemic period, when the agency averaged about 4,300 inspections/year. It says Rogers offered no date when the backlog of uninspected facilities might be cleared.

Rogers indicated FDA’s efforts have been hampered by staff departures, including long-time inspectors who found jobs that allow them to work from home. “There’s a significant cost to the agency associated with the loss through attrition of an experienced investigator,” he said. “We need to retain these people and we are.”

FDA said in a statement to AP that it receives inspection details from international partners, which help FDA decide whether a visit is necessary. It also began to use video and other online tools to evaluate plants remotely during the pandemic, it said. In its statement, FDA said it “must be judicious and apply a risk-based approach” due to the “enormity” of its workload and limited budget.

The story says the inspection slowdown has drawn the attention of Congress. “House Republicans have peppered the agency with dozens of inquiries about the program since 2023,” it reports. “In their most recent letter, members of the Energy and Commerce Committee ask regulators to explain why FDA staffers making high-priority inspections in Asia are reporting less than half as many violations today compared with pre-Covid-19. ‘The committee is concerned that FDA’s fear of triggering additional drug shortages is driving the decreased rate that FDA issues Warning Letters,’ the committee said.”

Rogers rejected that argument, AP says, responding that agency inspectors follow strict guidelines when conducting inspections and that decisions about managing drug shortages are handled separately by other parts of the agency.