Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer...
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Transcript of Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer...
![Page 1: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/1.jpg)
Industry Recommendations on Evaluating OTC Consumer Behavior
Douglas Ws. Bierer, Ph.D.
Consumer Healthcare Products Association
![Page 2: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/2.jpg)
Industry/FDA History on Consumer Behavior Research
CHPA Regulatory and Scientific Conference workshops
Consumer Behavior Roundtable – 2005 Points-to-Consider Document
![Page 3: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/3.jpg)
Recommendations for Evaluating Consumer Behavior
Decisions about whether
consumer behavior is “acceptable” should be based on actual risk to
consumer
![Page 4: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/4.jpg)
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
![Page 5: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/5.jpg)
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
![Page 6: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/6.jpg)
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
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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
![Page 8: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/8.jpg)
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
![Page 9: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/9.jpg)
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
![Page 10: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/10.jpg)
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
![Page 11: Industry Recommendations on Evaluating OTC Consumer Behavior Douglas Ws. Bierer, Ph.D. Consumer Healthcare Products Association.](https://reader030.fdocuments.us/reader030/viewer/2022020417/56649f115503460f94c236e4/html5/thumbnails/11.jpg)
Must Consider Real-World Consumer Behavior Data
Consumer habits and practices Consumer surveys In-market use patterns Targeted educational programs
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Remarkable OTC Safety Record
>25 Rx-to-OTC switches approved --in part on consumer behavior data
Consistent record of overall safety No products removed
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Summary
Evaluating whether consumer behavior
is “acceptable” should be
based on actual risk to consumer