FDA Finalizes Guidance for OTC Label Comprehension Studies

A new document released by the FDA aims to improve the pharmaceutical industry’s approach to developing and testing nonprescription drug labels.

In its evolving efforts to improve OTC drug labels, the FDA announced Tuesday the availability of new industry guidelines for the design of label comprehension studies.

Often required before an OTC medication is approved—or following a change in formula or indications—these qualitative studies are conducted to assess the extent to which patients are able to understand and apply information from OTC drug labels. Products that fail to adequately communicate this information can cause patient errors that lead to serious adverse reactions.

The guidance is the most recent version of an earlier draft, which was released May 1, 2009, and incorporated advice given in a September 2006 meeting of the Nonprescription Drug Advisory Committee. After a period of public comment, the final guidance was released to help standardize the process for designing, conducting, and analyzing label comprehension studies for nonprescription drugs.

The document specifies methods for recruiting a demographically diverse audience that accurately reflects the US population. In addition, it focuses on recruiting participants with varying degrees of health literacy. Since OTC products are available for purchase to virtually anyone without a “learned intermediary”—such as a nurse, physician, or, in some cases, a pharmacist—very few factors should exclude an individual from participating, according to the guidance.

The guidelines also provide specific criteria for eliminating bias, defining success, calculating an appropriate sample size, writing and delivering questionnaires, and compiling a final report, among other topics.

The FDA will continue to accept public comments on the guidance. Comments can be submitted electronically at

www.regulations.gov using the docket number FDA-2009-D-0181. The complete document is available for review here.

For more OTC product news, visit www.OTCguide.net.

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