While much attention has been given to approving a COVID-19 vaccine, there's been little paid to the facilities where many vaccines are manufactured. A recent investigation in Vanity Fair features a former FDA inspector turned whistleblower who says that the FDA is not doing its job. Vanity Fair Contributing Editor Katherine Eban, the author of the piece, joins Hari Sreenivasan to discuss.
While there has been much attention given to the approval for a COVID-19 vaccine, little attention has been given to how the facilities, where many vaccines are manufactured, are being regulated.
A recent investigation in Vanity Fair magazine features a former FDA inspector-turned-whistleblower who says that the FDA is not doing its job and downgraded his findings to escape regulatory enforcement. The article also cites documents and letters charging the plants lack proper FDA oversight. The FDA responded that medical products are made "in compliance with good manufacturing practice."
I recently spoke with the Vanity Fair article's reporter, contributing editor Katherine Eban who is also the author of the book Bottle of Lies: the Inside Story of the Generic Drug Boom.
Who checks all these plants?
The FDA is responsible for inspecting the manufacturing conditions inside any plant that is making drugs that go to U.S. patients. They have an elite unit of highly trained investigators called Team Biologics. But surprisingly, it's only 14 people who are required to investigate conditions in 280 biologic plants that sell drugs and biologic products into the U.S. So, this is a, our investigation revealed it's a demoralized unit claiming poor supervision from inexperienced supervisors, there are personnel complaints inside that unit–this whistleblower alleged that he was not empowered to do his job. He felt that it threatened the safety of the American public.
So an inspector goes into a plant, finds things wrong. They file a report and presumably there's some sort of regulatory action taken against the company to clean up its act?
Right. So an investigator has to classify their findings in any plan. Those can be 'No Action Indicated,' which means they didn't find any problems, 'Voluntary action Indicated,' which means the plant should take some steps to make changes, or 'Official Action Indicated,' which is the most serious.
One of the complaints inside Team Biologics is that investigators are going in and finding conditions that they classify as 'Official Action Indicated,' which means: urgent, the plant needs to make urgent changes because there are real hazards there. And that bureaucrats back at FDA headquarters were downgrading those recommended classifications.
So does the FDA have any plans to increase the size of the team that goes and inspects the plants, considering what you're talking about, which is that we're heading into an era where there are going to be multiple vaccines that are going to have to be manufactured at an enormous scale to make sure that everybody in the United States?
Right. I'm not aware of any plans that they have to expand that unit, upgrade their capacities. And in fact, it's sort of worse than that, becuase if the COVID vaccines get approved through what's called an 'Emergency Use Authorization', it's not even clear that the FDA is going to require full inspections of these plants. Now, full inspections produce publicly available records. And what we learned from our reporting, is that so far there are only site visits happening, and memos written to file about conditions in these COVID-19 vaccine plants. They're not even producing fully public documentation.
So this comes in an era where there is increased vaccine hesitancy. The World Health Organization says that is one of the top 10 problems that's facing the planet right now. You know, an article like yours, I can easily see an anti-vaxx community picking it up and saying, here you go. Here's one more reason that we should not get a Covid vaccine or any other because these plants are horribly regulated. What's your response to that?
Well, I'm glad you bring that up, because when these issues first came to my attention, my reaction was I'm never writing that article because the last thing I want to do is contribute to vaccine hesitancy. However, I think it is critical that the FDA does its job. So we were very clear in the article that the anti-vaxxer position linking vaccines to autism is really based on debunked science, full of conflicts of interest.
You know, the issues we raised in this story have nothing to do with the anti-vaxxer position. They have to do with whether the FDA is doing the job it is supposed to do, which is ensuring that all these manufacturing plants follow good manufacturing practices.
Katherine Eban, thanks so much for joining us.
Thanks for having me.
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