House sends FDA fee bill to Senate for final vote

The Associated Press

Wednesday, June 20, 2012 | 1:09 p.m.

The House on Wednesday passed a major bill affecting the Food and Drug Administration that will increase inspections of drug manufacturing facilities overseas, while also funding review of new drugs at home.

Under the bill, approved by majority voice vote Wednesday, the FDA will have more flexibility to inspect sites in China, India and other countries. The number of U.S. drugs produced overseas has more than doubled over the last decade.

The underlying legislation renews an agreement under which drug companies pay the FDA to review new products. The FDA will collect $6.4 billion in fees from companies over the next five years. For the first time, the agency will collect fees from generic drugmakers to speed up approvals of their therapies. The FDA currently has a backlog of roughly 2,700 generic drugs awaiting review.

Other sections of the bill increase fines for drug counterfeiting and require drugmakers to notify the government earlier of potential drug shortages. More than 280 drugs are currently in short supply in the U.S., due in part to drug industry consolidation.

The bill sorts out differences in prior legislation passed by the House and Senate. House lawmakers approved their initial version of the sweeping legislation last month in a 387-5 vote.

The Senate is expected to vote on the bill next week, after which it will go to White House to be signed into law.