Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
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Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#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 more regulatory capture than actual useful regulation.
> The FDA’s relationship with manufacturers like Huahai, on the other hand, isn’t simple at all. If Huahai wants to make its own version of a generic drug and export it to the U.S., it needs FDA approval. But if Huahai supplies the main ingredient to a company that finishes the drug and sells it in the U.S., it’s required only to keep the FDA informed of any changes to the manufacturing process.
Good, now you have a US company you can actually prosecute severely. The $/mass of phamacuticals means testing a small sample of each batch is super easy and if you know the manufacture process it's not hard to know what secondary products/contaiminents you need to test for. This is pure negligence on the FDA's and the US importers part.
> “The only element who cares in this whole global supply chain is patients”
Not if you actually fine the American importers into the ground. And ban the at fault over seas companies.
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#3> Some of the contaminated valsartan contains as much as 17 micrograms of NDMA in a single pill. That’s equivalent to eating 48 pounds of bacon. The FDA estimates that for every 8,000 people who took the highest dose of contaminated valsartan daily for four years, there would be one additional occurrence of cancer.
Given the relatively small significance and the fact that this article was published in an issue with the blurb "Can You Trust Generics?" on the cover, I'm gonna say this is just more FUD from Bloomberg.
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#4> 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].
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#5> Some of the contaminated valsartan contains as much as 17 micrograms of NDMA in a single pill. That’s equivalent to eating 48 pounds of bacon. The FDA estimates that for every 8,000 people who took the highest dose of contaminated valsartan daily for four years, there would be one additional occurrence of cancer. Given the relatively small significance and the fact that this article was published in an issue with t…
For a blood pressure medication, 1 in 8,000 is not a small risk. Serzone, an antidepressant, has a similar risk rate for inducing liver failure, and was taken off the market.
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#6I wonder if the point of this, is to have us weigh getting "brand name" more seriously. There is no sensible reason to pay a premium for brand name if the generic is chemically equivalent.
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#7Are these problems only limited to the US? Do Canada or the EU have similar issues? Do they not import chemicals from similar suppliers or do they screen the better?
Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#8> 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/
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Re: Carcinogens Have Infiltrated the Generic Drug Supply in the U.S.
#9Are these problems only limited to the US? Do Canada or the EU have similar issues? Do they not import chemicals from similar suppliers or do they screen the better?
It's an issue in Canada[1] and the EU[2].
[1]https://www.bcpharmacists.org/news/update-august-18-2018-dru...
[2]https://www.ema.europa.eu/en/medicines/human/referrals/angio...