5 takeaways from AP’s report on the big backlog of uninspected drug factories
Associated Press
WASHINGTON (AP) — As COVID-19 swept across the globe in early 2020, the Food and Drug Administration pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical plants in the U.S. and overseas.
Nearly five years later, The Associated Press wanted to assess the FDA’s performance in catching up on inspections of factories that produce drugs used by millions of Americans.
The FDA keeps a list of drug facilities to inspect annually, prioritizing them based on their potential risks. But the list is confidential, so the AP created its own list by compiling public records of FDA inspections before COVID-19 and tracking which firms haven’t received a follow-up.
Here are five takeaways from the AP’s exclusive story:
The FDA hasn’t returned to roughly 2,000 drug manufacturing plants since before the pandemic
The overdue drug plants identified by the AP represent about 42% of the firms that are currently registered to produce drugs for the U.S. and previously underwent FDA surveillance inspections before May 2019. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies.
Under FDA’s own guidelines, factories that haven’t been inspected in five or more years are considered a significant risk and are supposed to be prioritized for inspection.
While most of the overdue plants are in the U.S., more than 340 are in India and China, the main producers of generic drug ingredients for U.S. prescriptions.
FDA officials say the U.S. drug supply is “the safest on the planet.” Because of its enormous inspection workload, the agency says it prioritizes facilities that pose the greatest risk to the public. The FDA has been using online tools and information from European regulators to supplement its efforts.
Drug inspections still haven’t recovered from pandemic disruptions
The FDA has been ramping up inspections since 2021, concentrating on overseas plants. But the agency still isn’t inspecting at the level it was before COVID-19. Last year’s inspection numbers were down 40% from the prepandemic period, according to AP’s analysis.
FDA staffers keep leaving the agency, hampering inspection efforts
The agency’s work has been slowed by attrition, according to one senior official. A wave of departures before and after the pandemic has left the agency with a less experienced workforce.
“We aren’t able to keep up with the pace of attrition and we have a number of investigators who are not as fully trained as their predecessors,” said FDA Associate Commissioner Michael Rogers. “We continue to increase their experience and training to get this group of investigators up to the same level we were able to utilize pre-pandemic.”
Vacancies persist among FDA’s workforce
Despite years of recruitment efforts, the FDA still has more than 220 vacancies among its inspection workforce, according to agency records obtained by the AP. Today, the FDA’s inspection team is 85% staffed, compared with more than 95% staffed in fiscal 2019.
FDA staffers are uncovering serious problems as they return to overseas plants
When FDA inspectors do visit factories in India and other countries, they sometimes find egregious violations.
An FDA inspector visiting Intas Pharmaceuticals in India, for example, witnessed a company employee “pouring acetic acid in a trash bin” to destroy company documents related to drug testing. The FDA issued a warning letter last year documenting a number of violations at the plant, including inadequate recordkeeping 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.
