generics arent the same as the original drug. The level of testing required to get a generics approved is ridiculous (basically just a dissolution profile test) and does not give a full picture at all on how the efficacy and safety profile changes in the body.
> In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.
On a related note, you don't need to show that it's actually the same, just that it's close enough. And that doesn't always work out for the best. An easy example being anticonvulsants. My younger brother died from an epileptic seizure and post-death examination determined the active ingredient of the anticonvulsant he was taking wasn't present in his blood. He had just been switched from brand-name to generic. Come to find out that this is/was a known issue that the FDA hadn't figured out how to solve. The generics aren't made using the same process and the end result isn't identical to the real drug.
I know a guy with for-real celiac disease. Although the active ingredient may be the same, not all generics are certified as safe for celiacs thanks to the additional padding in the pill.
Generics and brand name are NOT always equivalent depending on the drug and condition, and spreading this lie is incredibly dangerous to many people.
This is what happens when CEOs, politicians, and pundits are deciding health policies rather than the properly informed health officials.
Now if the insurance policy would be that a doctor must write medical necessity for avoiding the generic, go for it. But mandating that people can only take generics will cause harm.
Yup. It's either Prilosec (brand) or generic Omeprazole here in the US. More expensive than, say Rantadine, but perhaps better for chronic acid reflux. Relatively cheap OTC.
Another way to restrict competition is to stop competitors getting samples of your drug. Without samples of the original, it's impossible to prove a generic is equivalent.
I think they modify it a bit, parent that, put it in orange book, have insurance companies recommend this instead of the original, it could deter the generic makers because patients will be looking for the modified version say(extra long release).
And yet my mother is 100% convinced that the generic of a drug gives her chronic headaches while the "brand name" version doesn't.
If I'm not mistaken, the formulation could be wildly different as long as they match kinetics, yield, and safety profiles set by the FDA, and an individual may have some issue with one formulation over another.
I thought the article did a decent job of explaining exactly what the problem is in this case and communicating the scale of the risk. Your comment, on the other hand, sounds like a kneejerk dismissal entirely based on the headline not agreeing with what you thought was true.
Yes generics have proven to be broadly safe. That doesn't mean there aren't still issues that need to be addressed by tweaking or adding regulation. Yes even with carcinogens the contaminated generics are probably better than taking nothing. That doesn't mean that the contamination is acceptable.
It’s not just Zantac. It’s blood pressure medication and now diabetes 2 medication to lower blood glucose. If you read the Bloomberg article linked in the post, it’s even more scary. Basically they don’t test the drugs which is why They are being discovered one by one.
If you’re on any sort of generic medication, it’s probably manufactured in India/China and it’s probably contaminated. And if it’s not contaminated it might not even fit to specifications, ie too much of the drug or too little per pill. It’s happening all the time and the FDA is reactive not proactive. There’s a quote in the Bloomberg article about a judge not wanting to peel the onion because it could be too bad.
https://www.smh.com.au/business/consumer-affairs/regulators-...
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