Generic Drugs, Recalls, and PBMs

Thank goodness the World Health Organization has officially made “burnout” a medical diagnosis. Just in time for me, as I think I have a touch of that. Long story short, I’m not myself, and was going to pause on the blog article for this week. 

I’m not a quitter, though, so I am ranting. I tried briefly, but I can’t help myself.

I want to touch on a couple of topics mostly related to the other half of my identity, a pharmacist.

Generic drugs are being made in China and that’s bad, says a new article in Forbes, The Times, or wherever. Now people are in a panic. 

I’ve done my dog and pony on this for a few people in-store, but I think my take is worth a share.

Let’s rant about some healthcare and pharmacy-related issues, but tie them back to natural products, since it’s all one big inter-tangled mess.

You’ll laugh, you’ll cry.  Some say it’s better than Cats!  The play, not your pets.

A recent opinion piece in the NY Times brought to light some concerns with generic drugs.

The long and the short of it: generic drugs are being made overseas and oversight overseas isn’t overly great. In fact, it’s pretty minimal, and the article exposed some corruption and lies.

The purpose of the article was to make consumers aware of this problem: generic drugs are mostly being made in India or China now, and as a result, we may not be getting the same “quality” as before. Well, actually, the goal of the article was to get views and clicks, with the secondary purpose to give real information.  

There’s an unwanted side effect to this article and practically all modern media: frustration, heightening fears, and a distrust of a system. We didn’t get enlightenment with this article. It wasn’t “Hey wow I didn’t know that, I should pay attention more often and boo corruption!” We got “I don’t want generic drugs.”

Ignorance is bliss, amirite? How long have generics been made overseas?   

When we didn’t know about the supply chain of generic drugs, we were blissfully unaware and content with the system. Now we’re aware, but because of how this discussion was framed, we’re trying to change the wrong variable.  

We’re not looking to fix the real problems. Instead, many people have told me they no longer want generic drugs, at least not ones made overseas. This is my point: this isn’t a “generic drugs aren’t safe argument,” but a “the system is broken” argument.

Profits Over People

My hot take on this problem is multifaceted. The first piece this article brings to light are the major problems that represent what America has become: a breeding ground for mega-corporations.

Mega corporations want mega profit, so they ship everything overseas where regulations are weak, labor is exploited, oversight is minimal, and costs are low.

Having a global economy isn’t a problem. It’s that American companies use foreign suppliers who are exploiting something or someone to keep costs down. They bring it back here and charge us through the roof. Oh yeah, and they don’t pay taxes.

Paying people fairly and doing the right thing (making safe, pure products) cuts into profits.

Oversight is Overlooked

Point two in my argument for why this happens is because of point one.  

Many industries, but especially foods, drugs, and supplements need oversight. The FDA should be the body to do that. We don’t trust the FDA, as they are simultaneously both the devil with overreaching regulations and completely incompetent at their jobs.

Here’s my second angle on this discussion: mega-corps push for rules that strip regulatory agencies so they have free reign to keep exploiting everyone and cut corners.

The FDA is constantly defunded or their resources are limited, so they can’t do their job. You know, like inspect overseas facilities.  

I see an article like the one in the Times and don’t see it as enlightening. I see it as distracting.  

Articles like this one are squirrels for us hyperactive pooches overwhelmed with input:

The problem cycle here is a universal one: mega-corps grow more powerful, make their own rules, elude accountability, and break the legs of the agencies chasing them around trying to protect us.

We’re being told not to trust the systems that were built to protect us, and it’s easy to do so because those agencies act politically, are defunded, and often can’t do their job correctly. How much of that is part of the plan of the real rule makers?

Clean Products, Clean Companies

If we want clean drugs, we need tight regulations. I’m all for a “free market” whatever that looks like in reality, but I’m closing in on 40 and realize that when given the option, most people go corrupt. Many favor profits over long term goals, what’s right, etc etc.

I’m from Woodstock, but I’m not a hyper-progressive hippy, just someone who thinks there needs to be a healthier balance towards most of us and not so much towards these power-hungry and money-hoarding corporations.

Make it a non-profit, non-government, third party agency if you’re anti-FDA, anti-government. Bottom line, companies aren’t making good decisions and they aren’t self-regulating. In return, bad stuff happens. To us.

Recalls Keep It Real

The recent contaminant found in blood pressure medicines (losartan, irbesartan, valsartan) and subsequent recall has people worried and I assume that’s the reason for the original article.  

The constant coverage of the carcinogen that was found in these products makes it seem like the number of drug recalls are on the rise. I’m here to tell you that they are not. And if they are, that’s a good thing.

A recall doesn’t necessarily mean a drug is being rushed to market, nor does it mean there’s something shady afoot.  What it means, broadly, is that a business is keeping an eye on the process, has found a problem, and is attempting to address it.

We have to take a more positive approach to the recall process, understand it is part of the game, but hold companies accountable for providing us with quality.

You can access the REAL recall data and you don’t have to rely on the media to tell you what’s going on there. You have access to every drug, food, supplement, device, or any other recall. Simply google “FDA recalls” or go here and see them live. I encourage people to check this weekly at least, or even daily to stay on top of current events.

Recalls are a reflection of something problematic, but it’s also a reflection of an active system weeding out problems and getting better.

We can’t forget that humans are imperfect, so our systems and output will be too. A true, high quality organization/business/person/country would not care about perfection, but the pursuit of perfection.  

We want all businesses to actively monitor their output – customer service, environmental impact, ethics, and products – and work towards making a more positive impact and safe products, of course.

If something bad was released into the wild, we’d want to catch that ASAP, then recall it back, fix the problem, then work to prevent the problem in the future.

A strong recall process is essential to continuous quality improvement and best practices.

Recalls aren’t bad. Ready to drag supplements into this discussion?

Guess what’s missing from the natural products industry? A mandatory recall process. The FDA only has to notify a company that their product is a problem, it’s up to the company to make a recall.

We know about the carcinogens in the blood pressure meds because of an active recall process mandated by law with drugs. How many carcinogens end up in a supplement that are missed? Especially since oversight of the industry and subsequent compliance is minimal.

“Do we not trust supplements?” I’m not saying that. I’m saying we need to be aware and ask more questions.I’m saying we all should be pushing for more oversight. We should fear the potential products we are getting, but we should attack the system that allows those products to exist.

An active monitoring and recall process is how we ensure we are working towards perfection. It shows we are watching, reacting quickly, minimizing exposure, and protecting the public.

Of course, throw in money and big corporations, and that strict definition of continuous quality improvement shifts into idealism. Forgive me, but I believe if we have a framework for continuous quality, a recall process, great communication, and much needed oversight, we’d be in a better place – if drugs or supplements were made overseas or not.

Spread Pricing, Spread Thin

Speaking of corruption and pharmaceuticals, I’ve been trying to bring to light another source of corruption: PBMs.

When we think about why drugs cost so much in America, we normally blame manufacturers. We definitely should; they’re the ones inflating prices beyond any reason. Even if they’re making everything overseas for next to nothing.

Pharma isn’t alone in this. There’s a second force at play: PBMs, or Pharmacy Benefits Managers. They arose to help insurance companies handle the overwhelming amount of pharmacy claims generated each year. Now, they act behind a veil of secrecy where they steal from taxpayers and providers for one purpose: profit.

PBMs have consolidated to the point where three of them – Caremark (owned by CVS), Express Scripts, and OptumRx – control over 80% of the market.

With their power and lack of transparency, they’re driving up drug prices while cutting payments to providers (aka independent pharmacies, aka me!). The net result: pharmacies are closing while patients pay more than ever for premiums, deductibles, and copays.

NYS Senator James Skoufis released a report investigating PBMs. They found PBMs stole $300 million from NY taxpayers and providers by engaging in “spread pricing” on Medicaid alone. They pay my pharmacy $1 (not an exaggeration) for one medicine, then tell the plan it was $40, for example.

They engage in other monopolistic and abusive practices. They force customers to use pharmacies they own, either mail order or the chain stores. They use a separate price list for the pharmacies they own, so they pay themselves more AND get the spread, too.

We are trying to pass legislation to reign in these abuses, which, if continued, will lead to many independent pharmacies closing. I’m not trying to get rich.

I just want to get paid fairly for the great service we provide to the community and to ensure that independent pharmacies, like Village Apothecary, stick around for a while.

Turning Frustration Into A Real Fix

The final word here on the generic drugs, recalls, and PBMs is a bit of a dig at society.  

Why is there this pressure for moving drug manufacturers overseas? Why are PBMs playing games with providers but trying to keep copays low?

Because we want cheap sh*t.

We can’t have a simultaneous need to consume lots of cheap stuff and a desire for a high quality system. This goes back to my main hypothesis around supplements: people want cheap supplements, so supplement manufacturers cut every corner, including on quality controls.

Doing the right thing has a cost. Paying people decent wages. Putting in quality control systems. Using better ingredients. Not destroying the environment.

There are some of us that recognize this and will gladly pay a premium. Unfortunately, many of us willing to pay a premium are getting hosed too. Premium pricing, especially in supplements, isn’t indicative of quality. Typically with supplements, premium pricing is smoke and mirrors, dressing up a pig, [insert your favorite analogy here].  

So what do we do? I don’t know. We have to do something.  

The first bit is to identify a few issues:

  1. The media is fighting for your limited attention and energy, so they’re psychologically hacking their way to get you onto their content. Be aware of this.
  2. Because we have limited attention, we’re easier to manipulate. The foxes watch the hen house, and tell us to be cool about it. We’re tired, so we’re like “Whatever, sounds good!”
  3. There are so many things we do every day that are time saps. If we can cut that number in half and replace them with healthier pursuits, we’ll have more time to engage with the system.

The real answer, unfortunately again, is we have to take a more active role in the decisions we make. We can’t take anything for granted.  

When we do take action, let’s address the REAL problem with the system.  Avoiding generic drugs or spending hours researching what generic drugs are made in America today (as it changes all the time), is a waste of time.  

There are things that are worth fighting the system for.  I believe that independent pharmacies represent a time of our history where community mattered more than convenience.  

Today in an independent pharmacy, you’ll receive higher levels of personal care, an overall cost savings (when the system isn’t rigged in favor of profit), and greater reciprocal support of the community.

We’re here and surviving because of our community and because of the moves we’re making with Woodstock Vitamins, but unfortunately even that’s not enough to keep independent pharmacy afloat in such a system.

I’m asking for an awareness of what’s really wrong with the system(s).  I’m asking for support. This means choosing independent pharmacies. This means speaking to your representatives about PBM legislation.  

This means calling your federal reps and telling them you’re not happy with the current generic drug quality issues and the costs of medicines.

Healthcare can be considered sick in this country.  *WE* are the cure, not mega-corporations.

Just trying to keep it real…

Neal Smoller, PharmD
Owner, Pharmacist, Big Mouth

Dr. Neal Smoller, Holistic Pharmacist

About Neal Smoller

Dr. Neal Smoller, PharmD, is a licensed pharmacist: and owner of Village Apothecary, an independent pharmacy in the most famous small town in America—Woodstock, NY. He’s also the host of the popular wellness podcast, The Big Mouth Pharmacist.”


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