Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

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

bloomberg.com

Post reply on HN
Print view View original

101–110 of 142 posts

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

#101

Post by o09rdk »

lostmsu wrote: post #19
KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > 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…

>> 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 a…

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.

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

#102

Post by refurb »

mirimir wrote: post #97
ianai wrote: post #93

Earlier quoted context omitted.

“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...

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

#103

Post by bg24 »

dqpb wrote: post #75

Welcome to the future of warfare.

This deserves many more upvotes. External agents find cheap ways to destroy the country, and some internal agents sacrifice common man for quarterly bonus.

A virally popular device (non-prescription and cheap, for god’s sake) to detect toxicity levels, and connected app to visualize the health impact will serve as a wake-up call.

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

#104

Post by joe_the_user »

aresant wrote: post #14

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.

The FDA is intended to be this with teeth - clearly it has rather corrupted. What makes you imagine a private organization would be better?

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

#105

Post by userbinator »

From the Wikipedia page https://en.wikipedia.org/wiki/N-Nitrosodimethylamine

"NDMA is a yellow, oily liquid with a faint, characteristic odor and a sweet taste."

"characteristic" doesn't say much, but I often wonder how we know about the taste of a highly toxic chemical like this one --- and if someone died for it.

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

#106

Post by s1artibartfast »

dahfizz wrote: post #24
lostmsu wrote: post #19

Earlier quoted context omitted.

>> 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 a…

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.

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.

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

#108

Post by tmp190914pn2 »

fucking_tragedy wrote: post #4
KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > 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…

> 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/

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).

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

#109

Post by s1artibartfast »

pkaye wrote: post #46
sjg007 wrote: post #39

Earlier quoted context omitted.

It's an issue everywhere. Almost all generics are manufactured in India and China. And most with Chinese precursors.

Yeah but the article and some others are making it seem like something unique to the FDA. It seems to be a global issue and they all need to improve their quality control and testing processes.

To be honest, QC and testing has never really been the FDA's job. They perform a one time assessment for safety and effectiveness to prevent the sale of snake oil equivalents. They also have the power to inspect manufacturers periodically (maybe 1 in 100 manufacturers per year). Otherwise testing, QC, and release is self-regulated by the manufacturers.

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

#110

Post by refurb »

cwkoss wrote: post #43
KingMachiavelli wrote: post #2

> By 2014, the FDA had closed its offices in Shanghai and Guangzhou, leaving only the Beijing office with inspectors who could visit Chinese factories on short notice. > 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…

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.

Post reply on HN