chiver78
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Post by chiver78 on Jul 30, 2020 12:45:00 GMT -5
Link below discusses drugs and vitamins made in China (and India) and some quality problems Last penicillin factory in US closed several years ago when China undercut prices www.cfr.org/blog/us-dependence-pharmaceutical-products-chinaI’d be happy to have more drugs and the basic materials be manufactured in the US, also vitamins Think with the pandemic there are few if any fda inspectors going to China again, you think. inspections are still occurring, with precautions. my own company has sites around the world. FDA inspectors are travelling, and international regulatory bodies are sending folks here. I'm speaking from actual experience in the industry, with direct knowledge of how all of this actually works. as Mich said, if people understood all the hoops involved in pharmaceutical production, there wouldn't be posts like this about how fast-tracking a drug under direction of a President, because it simply isn't a thing. your link speaks in generalities, and is a blog post written by someone with degrees in Public Health. that is not a role that deals at all with regulatory process. it refers to a letter written by a Senator with a reference to an 80% of APIs coming from abroad, with 'the majority coming from China and India' with no source reference. I hold about as much value in that as I do with medical advice coming from the Oval Office. I have almost 20 years in the pharmaceutical industry, across a variety of different products. my current role is managing contract manufacturers around the US, and I can tell you that exactly none of my APIs have come from China or India. I am not at all trying to say that because I've never seen it, means it never happens. what I am saying is that the statistics you are leaning on are anecdotal. I would suggest you take a look at some of the entries here - FDA warning letters
these are actual warning letters, issued by the FDA. recipients hail from all over the world, for reasons across the map. some of the more egregious content can be found by looking at consent decrees. This example of a how a criminally-minded person can direct a company to skirt the regulatory bodies, resulting in the deaths of more than 100 people, happened right here in the US. Massachusetts, specifically. the point I, and others on this board, are trying to make is that where the drug is produced doesn't matter. it's still subjected to the same scrutiny and approvals process. and if (collective) you understood how complex that is, you'd stop worrying that Trump can skip over all of it to "make a vaccine that everyone has to have"
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jerseygirl
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Post by jerseygirl on Jul 30, 2020 13:41:37 GMT -5
Glad you know fda still inspecting sites. I do understand that fda keeps good controls on any drugs for us market. I’ve worked in pharma also for about 25 years - clinical research, but tangential drug supply issues. I’m curious about actual % api or generics made in China. In general think the US is too dependent on China and US would be better to be more independent even if just for supply chains
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chiver78
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Post by chiver78 on Jul 30, 2020 14:08:35 GMT -5
how do you feel about Chinese sites for American companies? or American sites of Indian companies, for instance? most of the largest pharma companies are international, the HQ of mine is in Japan. I'm trying to figure out if your issue is with Chinese oversight, or the actual manufacturing location. honestly, the actual location shouldn't matter either - there are construction standards to fall in to ISO and ICH design standards, USP water requirements for pharmaceutical use, etc. those standards mean that it shouldn't matter whether you are in Hometown, USA or on the moon.
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jerseygirl
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Post by jerseygirl on Jul 30, 2020 14:40:20 GMT -5
I worked for international pharma also, not troubled about manufacturing in China or India with US Fda oversight. But I am concerned if China (and India ) have a large % even if it’s only supply chain issues. Again I don’t have link now but ‘think’ majority of antibiotics aren’t made in us but in china.
I’m at the beach now
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GRG a/k/a goldenrulegirl
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Post by GRG a/k/a goldenrulegirl on Aug 2, 2020 9:42:23 GMT -5
I bet IMPotus has stock in Kodak. 😂 “Impotus” Snort
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TheOtherMe
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Post by TheOtherMe on Aug 2, 2020 10:37:54 GMT -5
It stands for Impeached President of the United States, which is a fact.
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sesfw
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Post by sesfw on Aug 2, 2020 11:21:36 GMT -5
It stands for Impeached President of the United States, which is a fact.
Bill Clinton?
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billisonboard
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Post by billisonboard on Aug 2, 2020 11:35:15 GMT -5
It stands for Impeached President of the United States, which is a fact.Bill Clinton? and Andrew Johnson. Andrew Johnson (December 29, 1808 – July 31, 1875) was the 17th president of the United States, serving from 1865 to 1869. He assumed the presidency as he was vice president at the time of the assassination of Abraham Lincoln. Johnson was a Democrat who ran with Lincoln on the National Union ticket, coming to office as the Civil War concluded. He favored quick restoration of the seceded states to the Union without protection for the former slaves. This led to conflict with the Republican-dominated Congress, culminating in his impeachment by the House of Representatives in 1868. He was acquitted in the Senate by one vote. His main accomplishment as president was the Alaska purchase .Andrew Johnson
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GRG a/k/a goldenrulegirl
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Post by GRG a/k/a goldenrulegirl on Aug 2, 2020 11:36:51 GMT -5
It stands for Impeached President of the United States, which is a fact. Or “Impotent POTUS compensating by becoming a ruthless dictator”.
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chiver78
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Post by chiver78 on Aug 2, 2020 12:32:07 GMT -5
It stands for Impeached President of the United States, which is a fact.Bill Clinton? he was impeached, yes. we are speaking about the current disgrace. please try to keep up.
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