Helix Exams

Date Submitted: 12/12/07
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Debate Builds Over Drug Companies' Fees to FDA



Added by Bryan

Description: Controversy continues to engulf renewal of the Prescription Drug User Fee Act (PDUFA), with the key issue being whether the law does enough to protect U.S. consumers from potentially harmful drugs.

The act was passed by Congress in 1992 to establish "user fees" that are paid by drug companies to the U.S. Food and Drug Administration to review and vote on new drug applications. In 2008, these user fees are expected to total $438 million and account for more than 42 percent of all the money the FDA receives for regulating drugs.

Now, several sides of the debate are expressed in a trio of opinions that will be published in the April 26 issue of The New England

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