Unique role of consumer studies in nonprescription drug development.
OBJECTIVE
To inform the health care community about nonprescription drug labeling and consumer studies unique and integral to the nonprescription drug development process.


METHODS
Data from consumer studies are essential for many nonprescription drug approvals. These studies are conducted to help predict actual consumer behavior in the marketplace if the product is approved. They test whether potential consumers understand a label (label comprehension study), can properly decide if a product is appropriate for them to use (self-selection study), and can use a product in accordance with the label (actual use study). The design and interpretation of these studies often pose unique challenges.


CONCLUSIONS
Consumer studies are often part of a nonprescription drug development program. Continued efforts to improve consumer research should result in greater access to safe and effective nonprescription drug products for the American public.
Leonard-Segal
Andrea
A
Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
Shay
Laura E
LE
Shetty
Daiva
D
Schiffenbauer
Joel
J
D002986:Clinical Trials as Topic; D003256:Community Participation / Q000379:methods*; D032882:Comprehension; D017277:Drug Approval; D004348:Drug Labeling; D006801:Humans; D004366:Nonprescription Drugs / Q000008:administration & dosage*; D012651:Self Medication
D004366:Nonprescription Drugs