Earlier this year, the United States Food and Drug Administration (FDA) reopened a proposed study to understand the way drug names influence patients and health care providers. The previous study, published in December, included suggestions for industry and their naming agency partners to avoid misbranding violations.
Under the December guidance, Best Practices in Developing Proprietary names for Human Prescription Drug Products, FDA noted that “A proprietary name, which appears in labeling, could result in such misbranding if it is false or misleading, such as by making misrepresentations with respect to safety or efficacy,” providing the example of “a proposed proprietary name that contains cure or that sounds like cure for a drug that treats the symptoms associated with a chronic disease would be concerning.”
In the new study proposed by the FDA, the Agency notes that it developed and pretested an “extreme, explicitly suggestive name (e.g., CuresFlux) and a neutral name (e.g., Zerpexin) for two medical conditions. Then, in the proposed main study, FDA plans to show roughly 500 consumers from the general population and 500 health care providers the pretested suggestive and neutral names plus five target names per indication (names that may suggest the medical condition and vary in terms of promise of effect). Participants will then answer questions about the names, before and after they have been told what the indication is.
The made-up drug names will include “efficacy implications (that) are more apparent than others and some will more clearly imply indication or benefits than others.” Additionally, FDA plans to focus on primary care providers for this study, as drugs for the two specific medical conditions (high cholesterol and gastroesophageal reflux disease (GERD)) are prescribed by primary care providers.
Comments and Response
The proposed collection of information also included some comments previously received by the FDA on the subject.
One comment recommended excluding “extreme, explicitly suggestive” proprietary names that FDA would never permit or names that suggest the drug indication and suggested instead that FDA use data that could assist the Agency in determining impressions produced by permissible proprietary names and names that would marginally fail FDA’s misbranding review. In response, FDA noted that “The purpose of including ‘extreme’ names in this study is not to have data on names that do not mimic real-world conditions, but to have something against which to compare the target names, which are similar to the kind of names that would be submitted to FDA for approval.”
Additionally, one commenter wondered whether FDA would provide sound files with the intended pronunciation of each test name. In response, and after further discussion with cognitive interview participants, FDA has decided to introduce sound files at the beginning of the survey.