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

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

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

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

ProductSponsor

ReviewingDivision

ProjectManager

ConsultRequests Name

ExpertPanel

RXSTUDYName Studies

ComputerAnalysis

SafetyEvaluators

DMETS

TeamLeaders

DeputyDivision DirOffice of

Drug SafetyRecommendation

Decision Made

ProjectManager

Request for ProprietaryName Consult