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If you haven't read it, I highly recommend the book 'Bottle of Lies' which was released a few months ago. It details systemic corruption in a number of generic pharmaceutical manufacturers. It also details how the FDA is struggling with monitoring overseas manufacturing.
https://www.amazon.in/Bottle-Lies-Inside-Story-Generic-ebook...
Don't be a Bloomberg shill. Ask yourself when you see an article published by Bloomberg who they are really serving with these stories.
This comment was downvoted in about 5 seconds from when it was published. This was a comment at the bottom of a comment thread. There is no way for that to have happened other than by a bot. Bloomberg uses third party-controlled bots on HN to control the discussion. Sad.
I would pay good money for a supply chain based “consumer reports” so I actually know what’s in my products eg - medicines! - supplements - food - clothing Clearly in the USA their is gigantic demand for organic / harmful chemical free products.
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 Sams…
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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 Sams…
You know, of course, blockchains do not magically solve the garbage-in garbage-out problem.
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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.
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...
Good to know that the US health care system will impose these individuals with the cost. Shame on them for not properly researching the product. They should have considered their consumer choices against the possibility of cancer years later. No doubt the medical bankruptcy some will have is deserved. Obviously sarcasm. This is, however, how the current US medical system behaves. It's impossible that these patients w…
You should able to sue the pharmacy and your insurer for sourcing and requiring tainted products that are not quality controlled. I would expect some class action lawsuits to appear shortly.
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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.
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You should able to sue the pharmacy and your insurer for sourcing and requiring tainted products that are not quality controlled. I would expect some class action lawsuits to appear shortly.
I hope so. After reading the Bloomberg article, I looked up my Losartan Rx. It's from a manufacturer's lot that was pulled by the FDA on Feb 28 of this year. The kicker is, my (major chain) pharmacy sold it to me this July...
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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.
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.
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There was an issue I read about with a drug where they did not test all the different dosages of a generic, and I think the behavior of one of the doses was not as expected because it didn't dissolve well or something. This was a psychiatric drug, and so of course, reports of problems went unheeded for years because patients were assumed to be imagining things. Saying "the drug does have to behave the same as the bra…
Yup. There have been a handful of approved generics that didn’t have bioequivalence to the branded. It’s not a perfect process, but it works in nearly all the cases.
We know that in nearly all the cases, any issues don't rise to the level where the FDA or the public identifies them. I doubt that the system is constructed in such a way that nearly all the problems are identified.
It seems to me that because drugs are developed to meet the absolute minimum standards for proving efficacy and safety, there's inherently going to be little if any margin for error in the manufacturing process and hardly any way to analyze problems. When reporting potential side effects, most drugs are going to be just above the noise level in their principle effect, so how are you going to determine what is a random unrelated issue and what is a negative side effect, and what is the consequence of a QA or design failure?