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Monday, December 17, 2012

Comments

Louise


Most of the difficulties reside in the terminology: Bioequivalent does not mean identical. It simply means that although the drug formula may have been changed, perhaps to keep costs down or to simplify manufacturing, the initial activity of the proprietary product must be preserved. Nevertheless, the requirement from the FDA may not mention the degree to which such activity must be preserved. Doing that would require the generic company to perform a protocol of tests which would bring back the generic product to the level of the initial one in research costs and possibly lose its “generic” label in the process.
That is why many patients complain that a generic drug does not work as well as the proprietary one or that it causes new adverse side-effects.
On the other side of the issue, lets us consider what might happen if, in the process of amending an original drug composition, a generic drug company discovers that its own new protocol has unexpectedly removed some of the original adverse side-effects. Can this company modify its warning label accordingly or does it need FDA approval to do so? In this second option, it would then be required to take its “generic modified” drug through a series of clinical trials for FDA approval. This would defeat the purpose of making a generic drug.
It seems that only way out is for the FDA to compel generic drug manufacturers to adhere to the original formula without any variation, thus keeping the ADR and the warning label constant. Any other variation would need to be re-assessed in its own merit.
N.B.[Streamlining between State laws and Federal laws would be greatly appreciated also.]

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