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Industry Perspectives on OTC Consumer Behavior Studies

Source: www.fda.gov
Topic: Consumer Behavior

Sort Desciption: Consumer Behavior Research. CHPA Regulatory and Scientific ... consumer behavior is acceptable. should be based on actual risk to. consumer ...

Content Inside: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer Ph.D. Consumer Healthcare Products Association Industry/FDA History on Consumer Behavior Research CHPA Regulatory and Scientific Conference workshops Consumer Behavior Roundtable 2005 Points-to-Consider Document Recommendations for Evaluating Consumer Behavior Decisions about whether consumer behavior is acceptable should be based on actual risk to consumer When Evaluating Consumer Behavior No magic overall number for success/failure All non-compliance is not the same An incorrect response may be an appropriate behavior No Magic Number Risk of non-compliance not the same for all label statements Each label statement/drug must be analyzed separately No one overall number of acceptance All Non-Compliance Not The Same Non-compliance dosing w/low tox drug non-compliance w/contraindicated drug Evaluation of consumer behavior based on consumer risk An Incorrect Response May Be An Appropriate Behavior Response may be benefit/risk decision Need to understand thought process Must consider medical significance of incorrect answer/action Talk to doctor should not be incorrect in self-selection studies Recommendations Pre-define OTC label elements critical to safe use Focus on the basis for consumer decisions Consider wide variety of real-world consumer behavior data Pre-Define OTC Label Elements Risks are captured in OTC labeling Based on Rx use history Consumer behaviors that may lead to potential risk Predefine label elements critical for safe use in an OTC setting Focus on Understanding Consumer Decisions Understand basis for consumer decision Self-reported information is valid OTC drugs should be approved if: Risk of non-compliance to critical label elements is low Lack of intermediary doesnt present an additional risk to the consumer Must Consider Real-World Consumer Behavior Data Consumer habits and practices Consumer surveys In-market use patterns Targeted educational progra ...