US House Bill will establish inspection parity, improve US drug supply

Ranking US Congress Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, Representative John Dingell, Health Subcommittee Chairman Joe Pitts and Rep. Tim Murphy last month introduced HR 3988, titled the Generic Drug and Biosimilar User Fee Act of 2012.

The bipartisan legislation authorizes a generic drug user fee proposal that was recently agreed to by the US Food and Drug Administration and generic drug manufacturers. The user fee provides resources to the FDA to ensure that patients have access to lower cost generic drugs more quickly. It also will enable FDA to inspect foreign and domestic manufacturers at the same biennial rate based on risk, thereby providing a level playing field for domestic and foreign manufacturers.

“This bipartisan legislation will give FDA the authority and resources it needs to review generic drug and biosimilars applications in a timely and effective manner. For some time, FDA’s generic drug review program has been starved of resources, which has meant fewer generic drugs on the market, and consequently higher medication prices for American patients. At long last, this legislation will help turn this untenable situation around,” said Rep Waxman.