FDA wants sponsors conducting label comprehension studies to take into account subjects' thought processes - reflected in their verbatim answers to test questions.

Firms must analyze this qualitative information about consumer comprehension as well as quantitative data on the number of responses deemed "correct" or "incorrect," the agency says in its long-awaited draft guidance on label comprehension studies for nonprescription products issued April 30.

Label comprehension, self-selection and actual use studies are consumer behavior research used to support applications to switch Rx drugs to OTC.

Sponsors use comprehension studies to test potential consumers' understanding of a drug's use and if they can self-select appropriately. The studies also test whether the subjects correctly understand warnings and contraindications.

"There may be times when the quantitative information reflects correct comprehension, but the verbatim responses do not, and vice versa," the guidance says.

"Thus, a clear analysis of both quantitative and qualitative data types should be provided" to determine whether consumers sufficiently comprehend labels, the agency says.

Building On NDAC Suggestions

The guidance incorporates suggestions from a September 2006 Nonprescription Drug Advisory Committee meeting at which panelists discussed the design of label comprehension, actual use and self-selection trials (¹ Also see "NDAC Calls For Predefined Endpoints In Consumer Behavior Trials" - Pink Sheet, 2 October, 2006., p. 3).

Building on suggestions from the meeting, FDA explains in the guidance that verbatim responses can shed light on what changes to the label firms must make to improve comprehension.

For example, if subjects answer questions incorrectly, sponsors should ask probing open-ended questions to assess why they answered the questions the way that they did.

In addition, a comprehension study should use direct, specific and unbiased questions that address a single item or issue, the guidance says.

Questions also should test whether subjects can accurately apply the information on the label, but should not gauge intended behavior, which FDA says is beyond a label comprehension study.

Define Study Goals And "Success" A Priori

The agency says firms should identify study objectives and define a successful target comprehension level prior to drafting the questions and conducting the study.

"A label comprehension study can have many communication objectives, but the most important objectives should be identified a priori," FDA says.

Sponsors should set communication objectives based on the drug's active ingredient and product class under consideration, the agency says.

Firms should base primary communication objectives on the label information with the greatest clinical significance, such as indications, contraindications, dosing instructions, when to stop using the drug and warnings, the guidance says.

Comprehension of primary objectives should be at least 90 percent, but could be higher for information with greater clinical significance, such as directions that pregnant women not use the product.

Secondary communication objectives, such as less critical information about the safe and appropriate use of a drug, also should be pre-determined and reach a comprehension level of 80 percent or greater, FDA says.

The draft guidance also recommends label comprehension studies use subjects representative of anyone who could potentially use the drug, whether or not they express interest in the drug, and include consumers who read below an 8 grade level (² Also see "No Simple Answers To Simplifying OTC Labels – NDAC Panel" - Pink Sheet, 2 October, 2006., p. 5).

Firms should conduct studies in settings where consumers would naturally inspect the package, such as a mall, instead of clinical areas, the guidance says.

- Elizabeth Crawford (e.crawford@elsevier.com)

Draft Label Comprehension Study Guidance Stresses Quality And Quantity

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