Biotech Values

[DewDiligence]

Re: The premise of the US generic-drug system

I understand from others that an ANDA generic co. need only certify that the active ingredient is the same as that present in brand version. I do not know whether my understanding is correct or whether it derives from statute or FDA rule.

Your understanding is partially correct but omits an important requirement: US generic drugs must have bioavailability in the range of [0.80,1.25] relative to their branded counterparts. Whether this bioavailability range is sufficient for identical or nearly identical safety and efficacy depends on the kind of drug in question, as discussed in #msg-46749843.

other ingredients in [a generic] formulation may well be different. That confluence of factors may or may not result in different safety or efficacy in different individuals. That is not a good way to run a health care system IMO.

The US healthcare system, which is one of the few systems in the world with fully substitutable generic drugs, has an inherent tradeoff between exactness and availability—see #msg-46885484. Regards, Dew