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Senate proposes new powers, funds for FDA inspections of drug and device facilities.(Food & Drug)


A revived safety proposal in the U.S. Senate would give regulators new funding and authority to inspect plants that make prescription drugs and medical devices, Bloomberg reported April 23.

Legislation introduced by Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) would empower FDA to collect inspection fees from companies and issue subpoenas or detain products when inspectors believe a product is adulterated or misbranded. The measure is similar to one introduced last year by the senators.

Lawmakers faulted FDA's lack of inspections last year after contaminated heparin from China was tied to hundreds of deaths and allergic reactions. The Government Accountability Office, the watchdog arm of Congress, and some FDA scientists say the agency has approved products without proof they're safe.

"Our legislation is a practical solution to beefing up the FDA's inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency's work," Grassley said in an e-mailed statement.

Last year, the agency started to station employees overseas to help review the increasing number of ingredients and finished products imported to the U.S.

Grassley serves as ranking member of the Senate Finance Committee and has often reviewed FDA's performance on various issues. Kennedy is chairman of the Senate Committee on Health, Education, Labor and Pensions, which is responsible for legislation concerning the

COPYRIGHT 2009 Washington Information Source, Inc. Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.

Copyright 2009 Gale, Cengage Learning. All rights reserved. Gale Group is a Thomson Corporation Company.

NOTE: All illustrations and photos have been removed from this article.


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