How FDA cuts could make the food and drug supply less safe

When Health and Human Services Secretary Robert F. Kennedy Jr. announced in March that he would eliminate thousands of jobs from federal health agencies, he promised that he would spare the inspectors who keep America's food and drugs safe by scrutinizing factories around the world.

Kennedy kept his word and didn't fire inspectors, but key support staffers who handled travel arrangements, reimbursements and more are gone, according to two current inspectors who spoke on condition of anonymity because they weren't authorized to speak to the media.

Some of the support staffers were asked to come back temporarily. But last week, they were told to go home again, the current inspectors said.

That loss of support could make it much harder to inspect factories producing things like baby formula, eye drops, cinnamon and a range of generic drugs, all of which have had manufacturing problems that led to recalls in recent years. In some cases, people were injured or died.

The uncertainty is a problem because the FDA was already short-staffed and has trouble attracting and keeping people who can make more money in the private sector.

Chris Middendorf, who spent most of his more than two decades at the FDA as an inspector, said if inspectors now need to spend at least a week handling trip logistics themselves, that's time they can't be writing up previous inspection reports, learning about new technologies and preparing for their next inspection. "So it's all just going to slow down the inspection process."

Middendorf, who is now senior director of pharmaceutical and biotech compliance at the law firm Hogan Lovells, said in-person inspections remain the gold standard for assuring quality. When it comes to drugs, the biggest risk factor in contamination is human error.

"What you don't want to see are basically operators touching [their faces], messing around with their mask by touching things with their hands they shouldn't be," he said, explaining that these errors can cause bacteria to get into sterile products. "But the only way you can see them is by standing outside the production window and watching for hours."'

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