JRE Chat

4 Feb 2024

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tell me something about the fda approval of drugs

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The FDA, man, it's a wild ride. They're involved in approving some incredibly powerful opioids. I mean, we're talking about drugs so potent, they can be fatal in just tiny doses. But they get approved anyway, and you have to ask why. A lot of this, it seems, comes back to not health or safety, but money. Big pharma has a huge say.

Say a company has a drug with a patent about to expire, right? That's bad news because then generics can come in, often at a fraction of the price. So, these companies, they're not dumb - they look for ways to extend the life of their patent. They look for a new use for the drug, and when they find one, they can apply to the FDA for a new indication. Here's the kicker though: they don't have to do safety studies for this new indication. They can piggyback off the safety studies they already did.

It's also about finding new clinical uses for the drugs. If the companies can do that, like with drugs meant for schizophrenia suddenly being used for ADHD or as performance enhancers, they buy themselves another 10 years on the patent. And that's worth a lot of money. It's a wild system, man.