1. Department of Health and Human Services Food and Drug Administration DMETS Evaluation of Proprietary Names Jerry Phillips, RPh Associate Director Office of Drug Safety CDER June 26, 2003

2. Department of Health and Human Services Food and Drug Administration PRE-MARKETING EVALUATION Begin Review at the End of phase II of an IND and 90 days prior to approval of NDA Proprietary Name Analysis –Expert Panel Review –Verbal and Handwritten Rx studies –Computer-Assisted Analysis Labeling and Packaging Analysis –Container, Carton, Package Insert, and Proposed Packaging Configuration Overall Risk/Benefit Evaluation Written Recommendation provided to Division

3. Department of Health and Human Services Food and Drug Administration WHAT IS DMETS LOOKING FOR? Sound-alike/Look-alike: –To currently marketed drug names –To other Medicinal Products –To commonly used medical abbreviations, medical procedures, and/or lab tests

4. Department of Health and Human Services Food and Drug Administration Contributing Factors for Name Confusion Similar indications Same patient population Identical formulations Overlapping strengths or directions Stored in same areas

5. Product Sponsor Reviewing Division Project Manager Consult Requests Name Expert Panel RXSTUDY Name Studies Computer Analysis Safety Evaluators DMETS Team Leaders Deputy Division Dir Office of Drug Safety Recommendation Decision Made Project Manager Request for Proprietary Name Consult