Industry Cost Estimates For Proposed Antibacterials Rule Dwarf FDA's

摘要

Total costs of reformulation, relabeling and safety/efficacy testing under proposed changes to FDA's tentative final OTC monograph for consumer antiseptics could top $2.7 billion, according to comments submitted jointly to the agency by the Personal Care Products Council and American Cleaning Institute. Moreover, the move could result in 7.5 million new cases of foodborne illness and more than $38 billion in health-care costs annually, the trade groups say. The organizations' cost projections are roughly 13 to 94 times greater than those included in FDA's regulatory impact analysis for the proposed measures, according to their comments.