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House AER bill

This article was originally published in The Tan Sheet

Executive Summary

Rep. Chris Cannon (R-Utah) introduces a House version of legislation mandating adverse event reporting for dietary supplements and OTC drugs Sept. 25. The bill goes to the House Committee on Energy & Commerce, where a hearing is expected shortly after the House reconvenes in November. The "Dietary Supplement & Nonprescription Drug Consumer Protection Act" (HR 6168) requires manufacturers, packers or distributors of OTC drugs or dietary supplements "whose name appears on the label" to report any serious adverse events to FDA, the legislation states. The provisions of the bill would take effect one year after enactment. Sen. Orrin Hatch (R-Utah) believes the introduction of the House supplement AER bill "will boost [the legislation's] prospects for enactment this Congress," according to a staffer. It is likely the Senate will vote on the related legislation (S 3546) in early October, according to several supplement industry trade groups (1"The Tan Sheet," Sept. 18, 2006, p. 6)...

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