In a move of bipartisanship, the House has passed a bill that would increase inspections of drug manufacturing facilities overseas, while also accelerating approval of new drugs at home.
WASHINGTON - In a move of bipartisanship, the House has passed a bill that would increase inspections of drug manufacturing facilities overseas, while also accelerating approval of new drugs at home.
Under the House bill, passed 387-5 late Wednesday, the Food and Drug Administration would have more flexibility to inspect manufacturing sites in China, India and other foreign countries. The number of U.S. drugs produced overseas has more than doubled over the last decade.
The underlying bill also renews an agreement between the FDA and the pharmaceutical industry under which companies pay the FDA to review new products. For the first time, the FDA will collect fees from generic drugmakers to speed up product reviews. The FDA has a backlog of roughly 2,700 generic drugs awaiting review.
House Republican Whip Kevin McCarthy praises the bill's passage. "I applaud the overwhelming bipartisan passage of this bill which is essential to keeping American innovation and jobs on our shores as well as ensuring we remain the world leader in this vital industry," McCarthy said.
Representative Diana DeGette (D-Co.), co-sponsored the bill and applauded it. "I am so proud we passed a bipartisan bill to create an early warning system so the FDA, drug companies and doctors can better respond to shortages, quickly and efficiently. Today, the U.S. House came together across party lines to take a significant step towards getting drug shortages under control and protecting the health of America's families," DeGette said in a statement.
The Senate overwhelmingly passed their version of the bill last Thursday 96 - 1. Senator Bernie Sanders (I-VT) was the sole opposition vote.
The two chambers must go to conference to reconcile the differences in the two bills before the legislation can be signed into law by President Obama.
(KFGO file photo)