In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID inspection figures. The Associated Press reported the inspection shortfall earlier this month.
Data compiled from the FDA’s inspection dashboard and analyzed by the AP show that the regulator conducted at least 4,200 drug plant inspections in every year between 2010 and 2019, before the numbers plummeted as the pandemic brought on travel and gathering restrictions.
After inspections bottomed out at 1,312 in 2020, they’ve bounced back somewhat. But in 2023, there were slightly fewer inspections (2,708) than in 2022 (2,719), with both figures far below the pre-pandemic levels.
Of the 4,700 plants that produce drugs in the U.S., 42% are overdue for inspections, according to the AP analysis of FDA data. It has been at least five years since any of these facilities has been inspected, according to the AP.
When asked to explain the drop off, the FDA said it does not comment on "third-party assessments of data."
“Post-pandemic, FDA saw a high turnover rate for investigators. Many steps have been taken to decrease attrition and we continue to competitively recruit to fill vacant investigator positions,” an FDA spokesperson told Fierce Pharma. “We are currently seeing our hiring rates outpace our attrition in the drug program. Once an investigator is hired, it can take two years or longer until they conduct independent complex inspections.”
The FDA’s inspection backlog is even more pronounced in foreign countries, the AP found, especially India and China, where the production of starting materials for drug manufacturing often takes place.
In India, 160 plants are overdue for inspection, with some having not been checked since 2015, according to the analysis. In China, where the FDA has only two country-based inspectors, according to the AP, there are 185 factories that are past due for inspection.
The agency told Fierce Pharma that the “enormity” of the fields it regulates, including drugs, medical devices and food, is “disproportionate” to its resources.
“We must be judicious and apply a risk-based approach, so we are maximizing the time our investigators have and the budget the agency is allocated for these inspections,” the spokesperson wrote.
An example of the problem surfaced last year when a factory in India—which wasn’t even in the FDA registry—produced contaminated eye drops that caused the death of four people in the U.S. and blinded more than a dozen others. The eye drops contained a drug-resistant strain of bacteria called pseudomonas aeruginosa.
Inspection of the Global Pharma Healthcare facility in Thiruporur, India, found 11 violations, including barefoot workers, cracked floors, protruding nails and problems with filters and container closures.
In January of this year, the FDA laid out plans to transform its Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII), with 1,500 staffers reassigned to product centers to work more directly on inspections and investigations.
In April, when FDA commissioner Robert Califf, M.D., faced the House Committee on Oversight and Accountability he said that the agency had “completely” reworked its inspection system in India and that more inspections were planned for 2024.
Additionally, the FDA said that there has also been an increase in “remote regulatory assessments for new drug applications,” which will allow it to conduct “more drug inspections each year.”