AP data analysis reveals how far behind FDA is on drug factory inspections

By Matthew Perrone, Nicky Forster and Shelby Lum

This idea grew out of years of reporting and AP health writer Matt Perrone’s deep knowledge of the FDA’s inner workings. In 2022, AP reported how FDA skipped thousands of inspections during COVID, including at a baby formula factory that triggered a national shortage. Then last year, after tainted eyedrops killed and blinded Americans, Perrone wondered about FDA’s oversight of generic drugs and ingredients made in India.

There was widely understood to be a backlog of inspections of manufacturers, but no one had previously tried to quantify the number. In fact, it wasn’t even clear how one might identify which plants were “overdue.” But Perrone spotted a passage in a GAO report that mentioned the FDA’s own internal guidance: factories that have never had a routine inspection or haven’t had one in five years should be prioritized.

Health and Science data journalist Nicky Forster embarked on the massive work of building a database of active factories that had been subject to routine inspections before May 2019. He then figured out which ones hadn’t been visited in five years.

They found that the FDA hasn’t returned to roughly 2,000 drug manufacturing plants since before the pandemic — about 42% of the firms that are currently registered to produce drugs for the U.S. and previously underwent FDA surveillance inspections. The plants make hundreds of critical medicines, including antibiotics and cancer therapies. The FDA isn’t digging out of this on its own: Last year’s inspections were down 40% from the pre-pandemic period.

Health and Science video journalist Shelby Lum produced a video in which experts and former FDA staff explained the stakes.

The work led a newsletter by medical news site Stat News. It also was picked up by Quartz and Newsweek.

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