Replies to post #90692 on Biotech Values

[north40000]

Counterfeit drugs

The WSJ link you provided reminds me of a real life situation in the U.S.
I was sitting in a courtroom listening to counsel for a proprietary drug co. and a generic co. argue their respective positions in an ANDA case.

One of the Fed. Cir. appellate judges said that surely the FDA will know whether the generic drug formulation is "the same" as the proprietary drug formulation because FDA has the necessary scientists and laboratory facilities to test whether the 2 formulations are actually the same. The generic co. counsel corrected that judge's mis-impression by pointing out the FDA does not do testing like the judge thought, but rather relies on the generic to follow the same procedure as the proprietary co. to make the pharmaceutical in question. The generic does certify that the active ingredient(s) of the respective formulations are the same, but the excipients may be different.

I do take certain medications that now have generic "equivalents."
I have found with some that the generic formulation does not have the effect that the proprietary formulation has. Is my experience unique?

Meantime, as necessary, I have switched back to the proprietary, branded formulation.

The discussion that Huckman had with the generic trade association CEO this morning on CNBC skirted the issue and experience I have had with some generic products.