US FDA steps add to pricing woes of pharma firms

The US Food and Drug Administration (FDA) has unveiled new regulations to promote generic drugs with the wider aim of lowering health care costs for US citizens — a move that will enable Indian pharmaceutical companies to launch more products in that country but will also intensify competition and increase pricing pressure.

On Tuesday, the FDA announced two measures – the publication of a list of off-patent drugs without approved generics, and expediting the review of drug applications where there were fewer than three generics in the market. The FDA measures are part of its Drug Competition Action Plan.

Experts