US FDA will accelerate generic drug reviews

A US Food and Drug Administration spokesman has stated that the agency will introduce accelerated approval procedures for some generic drugs in certain cases, a move that has drawn approval from the Generic Pharmaceuticals Manufacturers Association (GPhMA).

However, the FDA is also looking at the feasibility of charging user fees to generic drugmakers for handling fast-track approvals, a measure which, for branded drugmakers has come under recent fire for allegedly jeopardizing the FDA's independence (Marketletter October 9).

Steven Galson, Director of the FDA's Center for Drug Evaluation and Research, told reporters: "we recognize that there are certain situations under which it is advantageous to public health to expedite certain applications." He added that these included cases for the first generic versions of a drug where the patent is due to expire, as well as public health emergencies or shortages.