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REDUX/PONDIMIN WITHDRAWALS PROVOKE QUESTIONS OF OFF-LABEL USE PROVISIONS IN FDA REFORM BILL; FEN-PHEN CITED IN KENNEDY ATTEMPT TO CHANGE DEVICE PROVISIONS

Executive Summary

The Sept. 15 withdrawal from the market of Wyeth-Ayerst/Interneuron's anti-obesity drug Redux (dexfenfluramine) and Wyeth's Pondimin (fenfluramine) has raised concerns for some House members over provisions in the FDA reform bill (HR 1411) that would allow companies to promote off-label uses of products, Rep. Brown (D-Ohio) said at a Sept. 17 Commerce Health Subcommittee mark-up of the bill.

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