5 takeaways from AP’s report on the big backlog of uninspected drug factories
WASHINGTON — When COVID-19 swept the world in early 2020, the Food and Drug Administration decided withdrew most of its safety inspectors from the field, creating a huge backlog of uninspected pharmaceutical manufacturing plants in the US and abroad.
Nearly five years later, The Associated Press sought to evaluate the FDA’s performance in Catching up on inspections from factories that produce drugs used by millions of Americans.
The FDA maintains a list of drug facilities that must be inspected annually, prioritizing them based on their potential risks. But the list is confidential, so the AP created its own list by the compilation of public registers of FDA inspections prior to COVID-19 and tracking which companies did not receive follow-up.
Here are five pick-up points from AP’s exclusive story:
The drug manufacturing plants identified by the AP represent about 42% of the companies currently registered to produce drugs for the U.S. and that previously underwent FDA inspections before May 2019. The plants produce hundreds of crucial drugs, including antibiotics, blood thinners and cancer therapies.
Under the FDA’s own guidelines, facilities that have not been inspected for five years or more are considered significant risk and should be prioritized for inspection.
While most of the factories late in construction are in the U.S., more than 340 are in India and China, the top producers of generic drugs for U.S. prescriptions.
FDA officials say the U.S. drug supply is “the safest on the planet.” Because of its huge inspection workload, the agency is prioritizing facilities that pose the greatest risk to the public. The FDA is using online tools and information from European regulators to supplement its efforts.
The FDA has ramped up inspections since 2021, focusing on foreign factories. But the agency is still not inspecting at pre-COVID-19 levels. According to the AP analysis, inspection rates last year were 40% lower than in the pre-pandemic period.
The agency’s work has been slowed by attrition, a senior official said. A wave of departures before and after the pandemic has left the agency with a less experienced workforce.
“We can’t keep up with the pace of the attrition and we have a number of investigators who are not as fully trained as their predecessors,” said FDA Associate Commissioner Michael Rogers. “We’re continuing to add to their experience and training to get this group of investigators up to the same level that we were able to use before the pandemic.”
Despite years of recruitment efforts, the FDA still has more than 220 vacancies among its inspection staff, according to agency documents obtained by the AP. Today, the FDA’s inspection team is 85% staffed, compared with more than 95% in fiscal 2019.
When FDA inspectors visit factories in India and other countries, they sometimes find serious violations.
An FDA inspector visits Intas Pharmaceuticals In India, for example, we saw a company employee “throwing acetic acid into a trash can” to destroy company records related to drug testing. The FDA issued a warning letter last year documenting a number of violations at the plant, including inadequate record-keeping and manufacturing practices.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.