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>> The FDA checks less than 1% of drugs for impurities or potency before letting them into the country.

> For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation.

I wonder though if this statement misrepresents the facts. If they check only 1% of the entire import volume at random, that is totally normal and what I'd expect them to do.

I agree, I think the statement is ambiguous.

1% of all products (e.g. one pill from every bottle of 100 pills) being tested seems like plenty.

1% of shipments (1 out of 100 shipments is sampled) seems insufficient.

Even 1% shipments would be okay, IMO. I interpreted it as "99% of drug products never get inspected", which is way worse.

It’s more like the later than I’m comfortable with tolerating.

Very ambiguous.

Generally how it works is you submit a proposed purity level to the FDA, with rationale and backup by your own validated analyses.

The FDA dives into it and says “this is reasonable” or “this won’t work” or “based on the chemistry, you need to test for X also”.

Then they require you to “release” any product you make, showing that it conforms to the agreed upon purity. If it fails, they expect you to follow up and figure out why.

Note, most of this is done in good faith - the FDA isn’t repeating the science in a lab, but they pay enough attention that if you’re making things up, it’ll be apparent in the data. The CMC (chemistry manufacturing controls) section of the NDA can be hundreds of pages long.

When it comes to inspections, they are typically random (but if you have a bad track record they happen more often). They can happen any time and they’ll look at all your processes, not just for a specific drug. Don’t have a record that you cleaned your equipment between runs? That’s a paddlin’.

Repeatedly run tests until you get a “pass” result? Yeah, your product will get banned from importation.

But yes, much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive.

“much of the regulation is based on good faith simply because the manpower required to verify everything made would be massive”

This is where I wish there were more tolerance for enough government spending to employ as many people as it would take to test properly. We’re talking about medication being used multiple times a day for long term-amongst many uses.

The FDA has been downsized many times over the past three decades. So what we're seeing here is not at all unexpected.

The FDA’s budget is more than 6x what it was in 1992.[1]. An increased every year since then.

What do you mean downsized?

[1]https://www.everycrsreport.com/reports/R44576.html#_Toc82198...

That's no inflation adjusted. And it's also not adjusted for processing load. But it does show the greatly increased role of user fees, which I gather has facilitated regulatory capture.

Inflation hasn’t been 600% since 1992.

Not sure what processing load is, but if they’re asked to do more that could be an issue, but I wouldn’t call it a cut.

I do remember reading about cuts in FDA resources. As an excuse for why they'd missed so many violations.

Checking, I see that it was Reagan era cuts.[0] So the timeline that you cited begins in 1992, which was probably the minimum funding level.[1,2]

Also, Hatch-Waxman was approved in 1984, which increased the workload considerably. And then there was the first generic drug scandal in the late 80s. That's what I was thinking of.

0) https://academic.oup.com/shm/article-abstract/29/1/202/24722...

1) https://www.everycrsreport.com/reports/R44576.html#_Toc82198...

2) https://sci-hub.tw/https://doi.org/10.1093/shm/hkv106

The think the accurate statement is that 1% or product lines have had a shipment sampled. The FDA is not in the business of performing QA testing, that is the job of the manufacturer. It is better to think of them as a legislative body.

Maybe a special duty office for this should be created. (Like for meat and meat products in EU.)

1% of the entire import volume would far more than necessary to test so it made more sense that it's only 1% of batches or shipments.

I agreed with that statement, but from the perspective that the FDA should drop its regulatory capture activities, and increase that 1% to a bigger sampling N. That is, they're focusing their efforts on the wrong problems.

The problems in the article amounts to fraud. Police that and let people decide what they want about what they're seeking.

> These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation.

It lends more credibility to the fact that the FDA is notoriously underfunded when it comes to ensuring the safety of drugs[1].

[1] https://www.ncbi.nlm.nih.gov/books/NBK52926/

An industry that sells drugs would want the regulating authority to be underfunded when it comes to insuring the safety of drugs.

Really? Back when the FDA was underfunded in the 80s, there was a massive backlog in drug approvals that cost drug makers billions. They happily coughed up fees to better find the FDA.

Underfunding certainly can(has?) interfere with their ability to do their job. But proper funding might not help if regulatory capture is also in play.

I'm of the persuasion that governmental organisations need to be shaken up from time to time to prevent ossification, stagnation, inefficiencies, regulatory capture, ideological capture, etc... but the new agency needs to utilize the pieces from the old agency (not to start from scratch).

Seems like "every company in drug supply chain must independently test each batch of received drug via GC/MS. That company is liable for any impurities found downstream in un-rejected batches" would be a nice regulation.

Companies don't want to do their job, they say this is "excessive regulation that is killing the economy".

This already kind of happens. You declare a starting material and then test it to make sure it’s pure. You do the same for the next step all the way to the finished product.

In this particular instance, the process caused the impurity, so it wouldn’t be reasonable to punish the company that sent them starting materials.

Companies that import drugs or precursors from China should independently test the product. Use a block chain to enforce trust.

> Not if you actually fine the American importers into the ground.

Sounds like an invitation for the importer to be a nearly judgement proof shell that just gets abandoned at the first sign of trouble.

> And ban the at fault over seas companies.

That part sounds more effective.

Jail time for high level execs will make sure that they don't cut cost by neglecting quality.

Sure, but it's not clear-cut. Executives can be (in good faith) fooled and that's a problem. You can't just jail people just because. I'm happy seeing the Purdue Pharma people get strung up, but I think we need due process and reasonable doubt as well.

They aren't being strung up, by any stretch.

Considering the fine American tradition (dramatically amplified in the last decade) of underfunding every important regulatory agency and then hollowing it out through other methods, it doesn't seem very surprising that the FDA is bad at checking products. Hard to imagine closing offices because of "regulatory capture", if anything the big US companies would want more enforcement on foreign generic drug manufacturers to secure their hold on the market.

Dunno how much the US FDA is to blame here: these API plants pretty much supply the world with generics.

If anything, it's the FDA that's doing foreign plant inspections and every other country's regulator just does what the FDA does.

My real question is: Why is each country doing its own inspections? Why not one global inspection?

Everyone else is getting a free ride from the FDA's work.

> For a regulator body who's job it is to make sure medical products are safe and available. These comments, if true, lend credability that the FDA is more regulatory capture than actual useful regulation.

This feels like a typical right-wing playbook item: defund and de-scope government organizations until they can't be successful, then point at how bad they are, and privatize them or shut them down. Government agencies don't work unless you pay for them.

Regulatory capture is a separate issue from privatization.

Regulatory capture is when there is a powerful government regulator, but it has been compromised by the companies and is used to prevent competition to those companies.

For example - Boeing successfully convinced federal government regulators to prevent Bombardier from selling a 737 competitor in the US.

Indeed, although I suggest that that comes about in part because the government fails to fund these organizations to the level required for self-sufficiency forcing them to outsource more and more of the work onto the only "competent body" willing to take on the job free of charge: the companies themselves. This creates a relationship where the companies have a disproportionate share of the power, and can dictate things like anticompetitive practices. It's basically a case of "give us what we want or your costs skyrocket."

That's all beside the point.

As long as outside entities can dangle future low-effort, high-compensation posts to government officials in exchange for present favors, regulatory capture will remain a fact of life.

It's an incredibly tough problem. Even if we prohibited regulators from ever working for the regulated, it's so easy to get around that with nonprofits and shell corporations.