US FDA for greater freedom to generic companies

Generic manufacturers would be required to inform brand name manufacturer about labelling change

US drug regulator FDA is planning to allow generic-drug makers, including those from India, to independently update product labelling when they discover new safety data, a move which can bring them at par with branded medicine manufacturers.

Generic manufacturers, which make cheaper but therapeutically equivalent versions of innovative drugs, would be required to inform the brand name manufacturer about the labelling change.

The US market is home to generic drug spending of about $300 billion every year and India produces nearly 40% of generic and over-the-counter products, while its share in the finished dosage medicine segment is about 10%.

Under the new proposal, generic drug manufacturers would be able to independently update product labelling (also called prescribing information or package inserts) with newly- acquired safety information before the FDA's review of the change, in the same way brand drug manufacturers do today.

If the proposal goes ahead, then generic drug makers need not wait to update product safety information until the corresponding brand name product has received approval to update its safety information.

"More than 80% 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.