Generics Firms Oppose ICH Standards

US generic drugmakers fear that new harmonized stability testing requirements developed by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use might be applied to their products.

the National Association of Pharmaceutical Manufacturers has told US Food and Drug Administration Commissioner David Kessler that generic submissions cannot be compared to New Drug Application submissions containing safety and efficacy data, and extensive chemistry information about a new drug substance for which no or little information was previously available. "Just as generic drugs do not have to submit safety and efficacy information, they should not have to re-establish the known intrinsic stability characteristics of known substances," it says.

The ICH requirements are for six months of accelerated stability testing on three batches per dosage form. At present, the FDA requires three months' testing on one batch for most Abbreviated NDAs, and it is this, says the NAPM, which is critical to many smaller generic firms' ability to continue production. "If this requirement were now to become three batches," it says, "the direct and immediate result would be that these companies would need to eliminate the development of many low-margin products from their product lines as not economically viable. many drugs which would ordinarily have been candidates for development would no longer be considered because the return on investment would not justify the development outlay."