OTC Label Costs "Underestimated"

The US Food and Drug Administration's assessment of the costs of itsproposed rule to standardize and simplify over-the-counter drug product labeling is understated, according to officials of the Nonprescription Drug Manufacturers Association.

They have told agency staff that while FDA estimates of the cost for branded OTCs of implementing the change would average $1,500 per shelf-keeping unit, the NDMA's own survey has found that the economic impact would be $15,000-$18,000 per SKU. The FDA also estimated the total costs to the industry resulting from the change, to be implemented over a two-year period, at $20 million. However, the NDMA's research suggests total costs over the two-year period of $114-$175 million.

Moreover, the Association adds, if the new regulation also requires packaging changes, costs to industry would rise by a further $250 million.