Reuters: Regulatory News: U.S. Senate passes bipartisan FDA funding bill

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U.S. Senate passes bipartisan FDA funding bill May 24th 2012, 19:54 By Anna Yukhananov WASHINGTON | Thu May 24, 2012 3:54pm EDT WASHINGTON May 24 (Reuters) - The U.S. Senate on Thursday showed near unanimous support for a bill that helps fund the U.S. Food and Drug Administration, a regulatory powerhouse with sweeping influence over the foods Americans eat and the medicines they take. The bill, which passed by a vote of 96 to 1, aims to speed approval of new drugs and devices and ensure food safety. It reauthorizes fees from companies like Johnson & Johnson, Medtronic Inc and Roche Holding AG that help speed FDA evaluation of new medical products prior to approval. These so-called user fees could provide almost half of the FDA's proposed $4.5 billion budget for next year. The FDA regulates products that make up about a quarter of the U.S. economy. Similar legislation has passed a House committee with bipartisan support and may move to the full House for a vote as early as next week. In a rare show of cooperation between Democrats and Republicans, Senate leaders sped the bill through the Democratically-controlled chamber, emphasizing its importance in protecting consumer safety and promoting innovation in medicine. "This bill is a shining example of what we can achieve when we all work together," said Senator Tom Harkin, a Democrat from Iowa and chair of the Senate committee that oversees the FDA. Industry user fees, first enacted in 1992, give the FDA millions of dollars annually to review new products for the U.S. market but must be renewed every five years. The current version is set to expire in September. Starting this year, for the first time the FDA will also collect fees from makers of generic drugs and of copycat versions of complex biotech drugs, known as biosimilars. Link this Share this Digg this Email Reprints

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