After causing extreme shortages of drugs in US, the US FDA came to Canada and shut down production of 90% of injectables from a Sandoz site in Quebec. This was not based on any finding of injury; merely because they can and want to adhere to standards that are cosmetically appealing. We are in a war against disease, and being thrust back into 1890’s medicine in Canada by a US agency brings up images of international war crimes. Sandoz then had a fire in their plant that completely halted production – that just sounds fishy to me.
Findings as I have seen it:
- In some cases there was fear “crystal” could be seem – obviously it is going to be the drug in question and that would disappear when diluted and so merely cosmetic.
- Their equipment was not clean enough even though Sanoz said it was – any residue left is going to be baked on product left by autoclaving. Intramuscular injections wold not matter. A warning that any particulate matter seen might require use of a filter in the IV line or be diluted out would have been sufficient though I suspect when product is IV diluted, it would disappear anyway.
- They didn’t test every lot number – OK fine them $500 million and use that money to put independent people in place to check every lot number.
If the Canadian government had any balls they would ask the FDA to present to a committee what actual (not imaginary) damages have occurred and fine them $500 million for making our country go back to the stone age.
If president Obama doesn’t want imaginary images of an”ugly american” propogated in this country, he better work fast.
And Sandoz – a boiler fire? – come’on – you have to do better then that – I am told there are multiple sensors on a boiler and to have missed a fire would just not happen…
I am so angry I could spit…One is left to think – who was the FDA really working for? – the people who propogate war crimes? – or non-generic companies who want cheap generics discredited?
People are going to suffer and cancer victims not get treatment and that is just for starts.
And Sandoz – are you in this to make everyone mad at the FDA?
Sorry, getting paranoid in my old age…