Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.

I made this account to respond to exactly this question.

The FDA's legal basis to regulate medicines is actually incredibly weak and really hasn't changed much since the 1930s. One of the examples is exactly this case. The FDA only regulates finished medicines in two cases a) brand name or b) generic equivalents. Leaving aside brand name drugs for the moment getting approval to sell a generic equivalent doesn't look anything like what you would expect. What people generally think is that generic drugs are 'copies' of existing brand name drugs and the FDA cares about making sure the generic guys are producing the same drug as the brand name one.

This isn't what happens at all. A manufacturer has to demonstrate similar blood level uptake as the FDA approved equivalent drug using a very similar approval process for the brand name drug. This requires an incredible effort that is substantially the same as getting an original drug approved.

The bottom line is that the FDA doesn't examine the on-going manufacturing of the drug much or supplier reliability much at all. If a manufacturer can pass blood level equivalence nothing else really matters. This equivalence is only valid for the direct manufacturting producer of the drug, not the company marketing it. The reality is that if you want to get FDA approval for a generic you might as well partner with a firm outside the US that knows how to handle this process because its a waste of money jumping through FDA hoops to certify a new facility in the US.

Once you have proved equivalance you can start selling the drug. At this point, the FDA is basically done. The FDA basically dones't care anymore and has very weak sanctions to enforce safety compliance.

The FDA can't do anything about this situation on its own; the way drugs are approved is directly established by law that dates back to the 1930s. I notice a lot of people in this thread suggesting that FDA leadership is bought off and does the work of the drugs companies. I assure you this is not the case.

FDA oversight of pharmacutecial ingredients is accomplished under an entirely different legal regime that has nothing to do with drug approval whatsoever.

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."

This could be an interesting case for blockchains. I normally am not a proponent of seeing everything thru that lens, but having a proper chain that is publicly verifiable is in the public’s interest. That said, there’s not a lot of incentive for people to reveal their supply chains — it’s often trade secret or hidden for a reason.

If there was a market behind it, then there might be a way. But good luck getting Samsung to tell you where their cobalt came from, or if some generic drug was made in a dangerous lab. Even if you knew it was Generic Factory 1736, it’s hard to know if that’s good or bad.

> I would pay good money for a supply chain based “consumer reports” so I actually know what’s in my products eg

That's already existed for decades, so why aren't you paying for it then?

Yep. Just happened to see this [1] article out of the corner of my eye while browsing. Really concerning. And from the sound of it, this Valisure place, not the FDA, is the one who discovered the issue. One wonders what use regulators are these days.

My infant daughter was prescribed ranitidine for reflux from age 3 months to about age 6 months. Anyone with more chemistry knowledge than me want to venture any guesses about how concerned I should be?

[1]https://www.nytimes.com/2019/09/13/health/zantac-cancer-ndma...