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Industry Recommendations on Evaluating OTC Consumer Behavior

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

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Industry Recommendations on Evaluating OTC Consumer Behavior

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  1. Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association

  2. Industry/FDA History on Consumer Behavior Research • CHPA Regulatory and Scientific Conference workshops • Consumer Behavior Roundtable – 2005 • Points-to-Consider Document

  3. Recommendations for Evaluating Consumer Behavior Decisions about whether consumer behavior is “acceptable” should be based on actual risk to consumer

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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 doesn’t present an additional risk to the consumer

  11. Must Consider Real-World Consumer Behavior Data • Consumer habits and practices • Consumer surveys • In-market use patterns • Targeted educational programs

  12. Remarkable OTC Safety Record • >25 Rx-to-OTC switches approved --in part on consumer behavior data • Consistent record of overall safety • No products removed

  13. Summary Evaluating whether consumer behavior is “acceptable” should be based on actual risk to consumer

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