Wow, quite a wake-up call for prescriptions and over the counter items, as well. Thank you for posting! This week I was looking for a common digestive aid in the drugstore. The brand name product was quite expensive. I checked the label on the cheaper generic version & noted it was manufactured in Romania. I thought, "Hmm....nah", and bought the brand name product.
This is right on the money. The fact that FDA inspections are unannounced in the US, but announced for oversees manufacturers, gives those ex-US facilities the opportunity to clean up records, literally clean the facility itself, and make sure the highest level people on staff are available to answer questions from inspectors. Unannounced inspections give a much better picture of what is really going on. This has been a problem for decades and gives pharma companies a big incentive to locate plants overseas.
Yes, it's certainly both. "Major players like AbbVie, AGC Biologics, Amgen, Novartis and Thermo Fisher Scientific are demonstrating confidence in the industry with substantial investments in new manufacturing facilities worldwide. Expansions in Singapore, Japan, North Carolina, Ohio, Iceland, and other regions signal a strategic push to increase global production capacity for new therapies, including biologics, cell and gene therapies, and mRNA-based medicines." https://www.drugdiscoverytrends.com/pharmaceutical-manufacturing-expansions-announced-globally-2024/
Thanks, Don, for this critically important article. Over the decades I've been taking medications for several chronic conditions, I've had to consult with my doctors and confront my pharmacists and insurance companies to obtain optimal dosages of my medications.
Wow, quite a wake-up call for prescriptions and over the counter items, as well. Thank you for posting! This week I was looking for a common digestive aid in the drugstore. The brand name product was quite expensive. I checked the label on the cheaper generic version & noted it was manufactured in Romania. I thought, "Hmm....nah", and bought the brand name product.
The safe choice. Thanks, Wendl!
This is right on the money. The fact that FDA inspections are unannounced in the US, but announced for oversees manufacturers, gives those ex-US facilities the opportunity to clean up records, literally clean the facility itself, and make sure the highest level people on staff are available to answer questions from inspectors. Unannounced inspections give a much better picture of what is really going on. This has been a problem for decades and gives pharma companies a big incentive to locate plants overseas.
Thanks, Stella!
Just remember, this is BIG GENERIC, not "pharma".
Big Generic got a huge gift from Trump in 2017, with its FDA Chief. And on the left demagogues pushed for "cheaper and generics."
Gina, I am in your debt for all your previous research on this topic. Thanks so much!
Oh no, the debt is mine. I’ll never forget your kind help early in my so-called career. ❤️
Yes, it's certainly both. "Major players like AbbVie, AGC Biologics, Amgen, Novartis and Thermo Fisher Scientific are demonstrating confidence in the industry with substantial investments in new manufacturing facilities worldwide. Expansions in Singapore, Japan, North Carolina, Ohio, Iceland, and other regions signal a strategic push to increase global production capacity for new therapies, including biologics, cell and gene therapies, and mRNA-based medicines." https://www.drugdiscoverytrends.com/pharmaceutical-manufacturing-expansions-announced-globally-2024/
Yes. I'm glad to see several U.S. states in that listing. And if these are branded drugs, I imagine they will face more regulatory scrutiny.
At least Japan and Singapore are not China and India.
The foundational problem with today's generics is that the guidelines for "bioequivalence" has been distorted to the point of irrelevance.
Add poor oversight and its expands the potentil for even greater levels of "non-bioequivalence."
Thanks, Don, for this critically important article. Over the decades I've been taking medications for several chronic conditions, I've had to consult with my doctors and confront my pharmacists and insurance companies to obtain optimal dosages of my medications.
One more thing to be depressed about. Sigh. (I was hoping some other person would die… not Dolly.) Love ya anyway, Don. Keep writing!
I'm not embarrassed to say Dolly was one of my favorites, musically and morally.
For me, too. Loved her. 💔
Thanks for sharing this. I had no idea this was the situation. I live in Australia, but I can only assume the situation is the same here.