U.S. FDA For Greater Freedom To Generic Company In Product Labelling

"More than 80 per cent of prescriptions filled in the US are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date," the FDA said while proposing the new norms.

For any given brand name drug, there may be multiple approved generic versions.

Under the current norms, generic manufacturers must notify the FDA of new safety information, and wait for the FDA and the brand manufacturer to determine the updated labelling.

This, industry experts say, leads to a delay in getting new information to health care professionals and patients.

While the proposed rule raises public health policy questions like impact on generic drug cost, a section of generic companies are of the view that the new policy can open them up to failure-to-warn suits.

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