Executive Summary

FDA raises its estimate of industry costs in a final rule requiring organ-specific label warnings for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs by April 29, 2010. The revised rulemaking bumps up first-year, one-time, industry-wide re-labeling costs to $62.7 million from $32.6 million, according to a June 30 Federal Register notice. FDA says its April 29 estimate of the products affected by the final rule underestimated the proportion of affected NSAID products, which will need expanded inner blister pack containers and outer cartons to accommodate the additional warnings. Packaging for OTC acetaminophen will not need to be made larger, FDA says. FDA still projects the total number of SKUs affected at 18,000, while industry consultant Eastern Research Group says it could be as high as 25,000 (1"The Tan Sheet" May 4, 2009)