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Some 2,000 drug-making firms haven’t had their operations inspected by federal regulators in years, as Food and Drug Administration inspectors leave the agency for better jobs in the private sector.
That’s according to the Associated Press, which reports that 42% of the 4,700 plants registered to make drugs for the U.S. haven’t been reviewed by the FDA since before May 2019. However, that list doesn’t include any new facilities that have registered with the FDA since the pandemic but have not yet been inspected. The agency’s internal list of sites has grown by 14% over the past five years.
Although plants that haven’t been inspected in five years or more are meant to be prioritized for “mandatory” inspections, many of them have still not been subject to inquiries. Most are in the U.S., although the AP reports that more than 340 are in India and China.
After the pandemic began in March 2020, the FDA put a halt to all but the most necessary inspections and wouldn’t return to regular operations until 2022. Last year, they were down almost 40% since before the pandemic, when around 4,300 were carried out annually.
Part of the problem is the FDA’s high rate of attrition; according to the AP, the agency has 225 vacancies in its inspection workforce, almost four times as many as before the pandemic upended its work. Those workers’ salaries start at roughly $40,000 a year — well below the nation’s average — but can eventually reach more than $100,000. But gigs as a private consultant can pay much, much more than that.
“Now I fly business class, I stay in nice hotels, I rest when I get there and nobody tells me what to do,” Jose Hernandez, a former inspector who transitioned into private work and now makes $250,0000 each year, told the AP. “I made the right decision.”
The agency told the AP that it is exploring ways to make its jobs more attractive, including by providing extra pay for experienced staff.
On a global basis, just 6% of sites inspected last year had serious problems. But the FDA also gives the vast majority of those companies advanced warning that it will soon inspect their facilities, a practice long-criticized by government watchdogs. And hundreds of plants overseas are overdue for inspection, continuing a years-long trend.
When misbehavior is found at facilities, it can often be deadly. The FDA’s move to open overseas outposts in 2008 came about after dozens of American deaths were linked to contaminated blood thinner from a Chinese plant that hadn’t been investigated.
Last year, FDA staff found cracked floors, barefoot workers, and other unsanitary conditions at a plant in India that supplied eyedrops to major retailers. An inquiry at Intas Pharmaceutical’s plant in northwest India discovered disastrous conditions that warranted a warning letter from the agency and led to some exports being blocked. In response, the firm shuttered the facility, creating a national shortage of the chemotherapy drug cisplatin.