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by chillwaves 3001 days ago
> There's a reason why generics and off-branded items are so cheap, and it's not because they don't do marketing. If you don't know: they're shit and the FDA will not prosecute large equivalency discrepancies.

You need to back this up with some citations.

2 comments

I think the OP is overstating by calling generic drug "shit". However, generic drugs do not have to be identical to the branded versions. As measured by pharmacokinetics, they need to fall within 80% to 125% of the branded version. So there is some variation. This webpage does a nice job explaining.[1]

The generic drugs also do not have to have the same excipients (inactive materials used to make the final drug product like a pill or capsule). Normally this doesn't matter, but if you have an allergy to an excipient, the branded might be the only one you can take.

Finally, there have been issues with some generic drugs, namely generic Wellbutrin. The FDA asked for bioequivalence data on some dosage forms, but not the 300 mg pill. That pill released drug much faster than the branded and patients had some nasty side effects as a result. I've also heard the same with some generic anti-epileptics. Epilepsy is a disease where drug levels need to be very tightly controlled.

[1]http://www.pharmacytimes.com/contributor/timothy-o-shea/2016...

Sure, do you want evidence that generic manufacturers don't follow strict quality control and equivalency testing? I can dig those up from the FDA's database.

Do you want evidence that generics manufacturers fake their equivalency tests? This is going to be harder, because the FDA doesn't publish the private sector data. I can try to see what I have on hand.

Do you want evidence that the FDA doesn't prosecute these huge problems? I can only point to the routine handing out of the equivalent of "yellow cards," i.e warnings of misconduct, but still allowing repeat-offenders to sell in the U.S.

Considering the large degree to which your claims contradict the conventional wisdom of "generics are just as good as name brand drugs," it would be good if you actually gathered and presented some of this evidence (and demonstrated that these issues are prevalent/damaging enough to matter) instead of just threatening to do so.
That’s nice, but we all want you go dig that up.
Please feel free to provide some citations. I think if you make claims that you say are easy to dig up evidence for, it would be good if you did so.