MTGreen
Platinum Member
- Joined
- Oct 12, 2022
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- 989
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- Montana, USA
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Agree on most points.I use the term dangerous as that is in most pharmacy law texts. You are correct that many are safe, but they still require a prescription. However there are certainly Prescription drugs that are truly dangerous as well.
There are very few multi sourced product advertisements on the market today. Drug companies got smart a decade ago. They focus on 2 areas now. The first is drugs for rare diseases. The second is what we call “me-too” drugs, which are bio similar drugs that another company already manufactuers (Very cheap to bring to market). I have not seen many biosimilar ads on TV.
I also agree the FDA red tape is ridiculous.
Potentially dangerous adverse reactions/effects are one of the reasons for the FDA designating a drug as prescription only; although another determination is that benefits must outweigh risks.
A "me-too" drug is another drug in the same class as an existing drug but changed enough to call it a new drug. Good examples here are with the original drug Prilosec(omeprazole), then all the me-toos in the same "proton pump inhibitor class" like Prevacid(lansoprazole), Protonix(pantoprazole), Nexium(esomeprazole), etc. They usually all have very similar efficacy and adverse reactions/effects. Me-toos are different enough that they don't require the patent on the original drug in the class (the "index" drug) to run out.
A "biosimilar" drug refers to another company replicating a large molecule protein brand name drug. Because of the size and complexity of these large molecule protein drugs, it is nearly impossible for a second company to reproduce the original company's process and produce exactly an identical large molecule drug. However, they can very closely reproduce it to have the same function and they are required to show the FDA that it is equivalent to the original drug. The concept is very similar to a "generic" drug which refers to small molecule drugs which can be chemically reproduced exactly and both generics and biosimilars require patent expiration before approval. To my knowledge all biosimilars currently require a prescription in the US.