The repercussions from this could be… interesting. Don’t get me wrong. I’m actually in favor of this concept (more work for me and my ilk), but it’s so vague there is going to be a lot of difficulty figuring it out. And the potential ripple effect will be disruptive, to put it politely.
The so-called “Buy American” order could represent a seismic shakeup of the drug industry: No one knows exactly how much of the American drug supply chain is produced abroad, but some experts insist up to 90% of critical generic drugs are made at least partially abroad.
It remains unclear, however, how broadly the order will be implemented — the executive order does not specify what drugs it covers. Instead, the order directs the Food and Drug Administration to decide which medicines will be subject to the new requirements. Certain drugs can also be exempted from the executive order if they’re too expensive to make in the U.S. or the U.S. isn’t already making them.
This is the industry I’ve been working in for a few years now. In the article it says that no one really knows where the drugs are made. Well…. here’s the thing. Even if the drugs get made in the US, where are the raw materials coming from? What kind of standards are they being held to? If the raw materials can’t be sourced globally, what will that do to the companies who were relying on the ‘budget option?’ Trust me when I say that there are a LOT of ingredients and solvents and what-have-you that go into pharmaceuticals. Those come from all over the place. If you are running a reputable place (like the ones I’ve worked at, thank goodness) then you are testing all those materials to be sure that a. they are what the label says they are, and b. they don’t contain stuff they shouldn’t. If you read FDA warning letters, you know that a shocking number of drug manufacturers don’t know, and seemingly don’t care, what’s in their ingredients. Or they trust their suppliers and take their word for it. Which they shouldn’t.
And it’s not limited to outside the US… this company, for instance, is one of the more egregious examples (although given what they make, I am not surprised). Located in WV.
Despite you becoming aware of the violative conditions described at your supplier’s facility, your firm continued to distribute adulterated homeopathic drug products and components you received from (b)(4). Only after the FDA inspection at your firm did you propose a potential corrective and preventive action (CAPA) plan to address the poor quality of drugs you received from (b)(4)….. You purchase mother tinctures and other components such as (b)(4) from outside suppliers, but you failed to test each lot of component received for identity before release for use in drug manufacturing.
I boggled. Several times. For one thing, ID tests are the easiest things to do. All wet chemistry, usually, and requiring no more than a basic lab… but that does cost money. And evidently some companies don’t give a flying flip that people will be relying on their stuff to not, you know, kill them.
Or this one, located in CA. So you know, ants in the kitchen? Gross. Ants found in an ostensibly aeseptic environment? Well. That’s not sterile. If ants can get in, microbes are teeming in there.
The FDA investigators observed vermin in your production areas. Specifically, ants were observed on the floor in your pre-gown room where non-sterile hairnets and masks are donned prior to entering the ISO 8 classified gowning room. In addition, an ant was observed on the outer surface of an FDA investigator’s sterile hood cover in the ISO 8 classified gowning room after he exited the ISO 7 classified aseptic production room.
And yet again… relying on your suppliers? Who are they, really? Trust, but verify. Always. Also: located in NY.
You failed to adequately control your incoming components used to manufacture both OTC and homeopathic drug products. For example, you received components from unqualified suppliers and used them in production without conducting adequate testing to determine their identity, purity, strength, and quality. Instead, you relied solely on suppliers’ certificates of analysis (COA) without establishing reliability of your supplier’s analysis through appropriate validation.
I could go on. And on, and on… the list is long. But I won’t. I’m just looking at all of this and thinking how much we never look at. The currents beneath the calm surface. Pharma is a big industry, and people want to jump into the money pool. For all you can say about the abuses of the lobbying system, the big players in the industry work very hard not to have the FDA look crossways at them. For all you can say about the FDA and it’s overreaches, it does go where no one thinks to look and shines a light on the potential poisons in the medicines.
It’s all complicated. Life is like that. I’m proud of what I do, to keep people safe. I know the people I’ve worked with over the years are concerned with the quality of their work. But there are a lot of people who don’t care. It’s a job. Get paid, go home at the end of the day. And those are the ones who worry me.
2 thoughts on “Drop a Pebble in the Drug Vat…”
I spent the last 7 years of my Shipyard career as a systems inspector and there were a lot of written instructions for test documentation, traceable calibration standards of test equipment, and duration of the tests.
An often heard whine was, “It’s close enough.”
I still don’t understand the mindset that thinks that clearly written requirements include an escape clause if you simply don’t want to follow the rules.
As a fan of the TV show “Restaurant Impossible”, I’ve often found myself wondering whereinhell the Health Department inspectors were during the months it took for the kitchen to get into the state seen in some episodes.
I guess there just aren’t enough to go around.
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