House supports checking drugs abroad

— The House on Wednesday passed Food and Drug Administration legislation 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 producedoverseas has more than doubled over the past 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 makers of generic drugs to speed up approvals of their therapies. The FDA currently has a backlog of roughly 2,700 generic drugsawaiting 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 previous legislation passed by the House and Senate. The Senate is expected to vote on the bill next week.

Front Section, Pages 4 on 06/21/2012

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