Dirty, Moldy Factories Tied to Recalled CVS-Brand Drugs

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If you've been stuck at home sick, chances are you may have been tempted to get well everything that the drug store offers there.

I'm gonna go to CVS's website, and.

If you've gone to the store or tried to order medicine online, and.

I'm going to look at cold and flu medicine.

You might have noticed a trend over the last few years.

It looks like there's a lot of familiar name brands. There's Mucinex and Pseudofed. Then there's also just a lot from CVS.

Health store brand medicine with major drug store labels on the packages that look a lot like their name brand competitors.

CVS Health Chest congestion relief seems to be everywhere, swirling down a bit.

Here, there's CVS Health Effervescent.

Cold relief from cof serr up, there's.

Robotussin, and right next to that CVS Health Tussin.

To allergy medication.

Allergy medicine, there is Civus Health.

Allergy Relief looks a lot like Zero Tech in terms of the packaging, but in a.

Few important ways they're different.

I think like the biggest name and in acids is Tums. There's that kind of like signature clear bottle with the blue top. They have those here. There is also, for you know, several dollars less, the CVS Health version of n acid tablets with a very similar bottle, that kind of clear bottle with a blue top.

And like a lot of people, I've been tempted by the cheaper prices of store brand drugs, but Bloomberg's and Ednie told me I might want to do more than just look at the price.

You often don't know who are making these brands. This drug store is not making their own store brands. They don't have their own manufacturing site. They hire someone to do that for them. And you it doesn't say on the box who does.

That, even though it doesn't say it on the box. And it got to digging, and what she found out is, and I don't say this lightly, pretty astonishing. Today on the show The Underside of store brand Drugs and the laws that shield pharmacy chains from liability, I'm David Gurra, and this is the big take from Bloomberg News. Our

CVS specifically has tried to boost their store brand drugs the last several years because one of the biggest things about these products is they offer higher margins for the company.

Higher margins. In other words, these store brand drugs make companies like CVS a pretty good profit. Anna says that around when big pharmacy chains were introducing these new offerings, she was covering the Food and Drug Administration for Bloomberg, and the influx of store brand drugs caught her attention because she was spending a lot of time looking at the FDA's inspection reports.

I noticed a lot of their inspection reports when they would send inspectors to places that were making drugs for the US in India and China were disturbing. There were a lot of issues with sanitation and hiding data that might not show the best results for these drugs and the quality of these drugs.

But these factories were not exactly household names, and Anna says it was pretty hard to figure out which US companies were contracting with these manufacturers. But about a year ago, Anna had a breakthrough when the FDA started recalling eye drops.

I was curious because there have been a in the last a little over a year, there have been a lot of eye drop recalls, specifically, you know, and some of these early on resulted and really bad eye infections and even death for some people.

Deadly eye drops terrifying on all accounts. So Anna did what she normally does, and she looked at the FDA's website to see which facilities the agency had inspected as a result of the recalls.

So the Food and Drug Administration clearly got interested in wanting to check up on other eye drop makers and make sure they were doing things the right way. And so when they started inspecting these other places, they found issues that caused them great concern. These were manufacturers in India. One of the main ones is called Killich and they made store brand drugs for CBS and others.

That is when it clicked for Anna. While it had been nearly impossible to know who was making a store brand drug, these recalls and the subsequent inspections were all public on the FDA's website, so for the first time she could link the manufacturing site of a recalled drug or eye drop with a store brand.

I realized in this database there was a way for me to find that, to search that way and to kind of parse the data. I wondered, hey, like, I feel like CBS has shown up in a lot more of these recalls than others, Like could that be a pattern? And so that's what I set out to see.

So Anna started crunching the numbers, and it turned out over the last decade, CBS had more than twice as many recalls for its store brand drugs as Walgreens. That works out to a little over one recall a month over the last ten years. But she wanted to double check her math to make sure there wasn't something she was missing about CBS versus its competitors.

I wanted to make sure, you know, there wasn't some reason for this, you know, do they sell more of these store brand drugs or something like that. But Walgreens and CBS have about the same number of health and wellness products. They're about two thousand for each company, so there wasn't a big difference there. And then I also look at the companies they were hiring and found that CBS was working with a lot more companies that were getting dinged by the FDA as well.

In other words, CBS was choosing manufacturers with a history of safety issues more frequently than say it's biggest rival, Walgreens. Who are these third party manufacturers you mentioned, Yeah, there are a lot of them overseas, a lot of them in India specifically making generic drugs.

And then there were some that had issues that CBS had hired as well in the US. But these are usually smaller companies that you haven't heard of before. They're not going to always be big name generic drug companies.

Even some of these recalls revealed some striking violations. One made drugs for kids that were too potent.

I did come across one that was also making pesticides, even on the same machines as drugs.

Those drugs included nasal sprays for and there's more.

It came across a few instances where they were using dirty water essentially like contaminated water to make the drugs. They found a ton of like mold colonies in this water that was right near these drugs that were being produced.

That one was making CVS branded pain and fever medications also for children, and it wasn't just the machines. The FDA's inspection reports the facilities also turned up issues with workers cleanliness.

There was one where they were making eye drops. There were workers in a sterile area that were working barefoot and you know, didn't have clean uniforms on.

It's shocking stuff, and it raised questions about what's going on with store brand drugs at all of the big pharmacies, but also at CVS in particular.

After you did your reporting, were you able to determine why CBS is an outlier?

I think that's a great question. They answered some questions from me through email by didn't go into great detail or let me talk to anyone there.

CVS sent Anna a statement.

The company said the store brand drugs quote are designed to maximize quality and safety. Work is intended comply with regulations and satisfy customers end quote.

But that didn't really answer her questions about CVS or about any other big pharmacy that's used one of these facilities to make store brand drugs. Because the thing is, all this information isn't secret, It's right there on the FDA's website.

Why don't the big pharmacies know this is going on? There if the FDI can walk in and see it.

Coming up after the break, a key loophole that allows big pharmacies to play by different rules and how you can identify products that could be questionable. So to recap Bloomberg's Anna Edny analyzed all the FDA's recall reports for store brand drugs from the big three pharmacies from CVS, Walgreens, and Walmart over the last decade, and she was able to connect the facilities that manufactured store brand drugs that had been recalled with which big pharmacies had contracted with them.

I did talk to a professor at Stanford, Kevin Schulman, and he's looked into the industry a lot. His concern is that essentially buyers of these drugs are looking to save money because many Americans assume it's a generic, is a is a generic like it's you know, doesn't matter which one you buy so which one's cheapest, and that's what we're going to go with, and that keeps driving

To break that down. Essentially, because a lot of us assume one generic drug is the same as a name brand drug. It's the same active ingredient, we tend to gravitate to the least expensive one on the shelf. So if a company like CVS or Walgreens or Walmart wants its brand to be competitive, lowering the price is a clear way to do that. There's also something else helping them compete.

So the CVS store brand and the other store brand drugs, they seem to have sort of a loophole.

Basically, the rules for the likes of advil or motrin or thumbs are more stringent.

They have to follow this guidance by the FDA, which gives them an idea of how they should be operating, how they should be making sure that what they're putting on the shelves still meets the quality standards that they're supposed to meet. And you know, they can't put anything out. They can't say, oh, we didn't know because we didn't make it. They have to assure when they put that product on the shelf that it's a quality product.

But when big name pharmacies use contract manufacturers to make generics, they're not beholden to the same regulations.

The loophole for the store brand drugs is that they are considered a private labeled distributor.

And this is where problems can crop up. Well, first, it helps to understand the difference between say the CVS Health brand pain killer and motrin.

So it needs to have ibuprofen in it, but it also can have different inactive ingredients. So you know, the pill takes a lot of other things to make it, you know, mashed together essentially solvents to make it all come together and to make it stick together, and you know, colors and things like that. But those inactive ingredients can have an effect on sometimes on how your body reacts to it, how your body digests it, and how it works for you.

So who is responsible then for guaranteeing that they are safe and effective? Is that the job of the US pharmacy chain is the job of the FDA, who's doing that work, if.

Anyone, so, in this instance, it would be the company that the pharmacy chain contract manufactures with.

Because the ultimate responsibility for the quality of any of these store brand drugs lies with the contract manufacturer.

The pharmacy chain kind of gets to look the other way and say, we put it on the shelf, We admit that, but we don't know. We don't assure the quality in there in the same way.

And as for the FDA, well, even though the agency issues these inspection reports, they only happen after a drug or a product has been reported for having an issue. It's reactive, not proactive.

They don't test drugs themselves on any large sort of scale, and certainly not over the counter medications. It's not a closely regulated industry.

You've done all of this reporting, and I wonder if this has changed the way that you yourself decide what to buy when you go to the pharmacy.

Yes, it does. I was just purchasing eye drops, and I did get the brand name Visian eye Drops, but I tried not to be too crazy about it, because you could go nuts just trying to figure out what would be safe for you and your Family.

This is the Big Take from Bloomberg News.

I'm David Gura. This episode was produced by David Fox. It was edited by Aaron Edwards and Rebecca Greenfield. It was mixed by Alex Sagura. It was fact checked by Audreana Tapia. Naomi Shaven and Kim Gittleson are our senior producers. Our senior editor is Elizabeth Ponso. Nicole Beemster Bor is our executive producer. Sage Bauman is Bloomberg's head of podcasts. If you liked this episode, make sure you subscribe and review The Big Take.

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