FDA Estimates Dollar Costs For Adverse Event Labeling But Doubts Persist
This article was originally published in The Tan Sheet
FDA's estimate of nearly $44 million for the dietary supplement industry to revise labels to comply with the adverse event reporting law may understate the actual burden by leaving out some key costs
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In its final adverse event reports labeling guidance documents released Sept. 1, FDA does not budge on defining "domestic address" as a full mailing address, or on recommending labels include statements directing consumers how to submit AERs
There is little chance FDA will aggressively enforce changes to dietary supplement and OTC drug labels recommended in the adverse event report labeling guidance, a food and drug attorney says
The Natural Products Association alerts dietary supplement firms to prepare to submit comments on expected estimates from FDA on manufacturers' costs to comply with adverse event report labeling requirements. The trade group says Oct. 7 a draft of a Federal Register notice the agency posted and withdrew the same day included cost estimates for compliance with FDA's December 2007 AER draft guidances. The guidances recommend that labels for supplements and OTC drugs include complete mailing addresses and statements informing consumers the information should be used for reporting AEs (1"The Tan Sheet" July 28, 2008, p. 12). NPA and other trade groups say neither requirement was in the law that made AERs mandatory and they should not be included in FDA's guidance