Jan. 27, 2020 – What’s in a name? The FDA’s Office of Prescription Drug Promotion (OPDP) announced a new study last week to answer whether the proprietary name of a prescription drug has an influence on how that drug is perceived and whether drug names that suggest or overstate efficacy misbrand those drugs or affect consumer and healthcare provider impressions of them.
The OPDP research study, announced Jan. 21 in a Federal Register notice, will “primarily focus on overstatement of the efficacy of the drug product,” and is designed to provide systematic, empirical evidence to answer the following questions:
- Primary research question: How, if at all, do names that suggest the drug’s indication affect consumers’ and/or healthcare providers’ perception of prescription drugs?
- Secondary research question: How, if at all, do names that suggest an overstatement of the efficacy of the drug affect those entities?
The FDA explains in the notice that sponsors propose proprietary names during the prescription drug approval process, and that these proposed names go through a name review that involves the Office of Drug Safety, OPDP and the relevant medical office. OPDP specifically is vetting the proposed name to ensure that it is aligned with the federal Food, Drug & Cosmetic Act provisions stating that labeling or advertising can misbrand a product if misleading representations are made.
“OPDP focuses its misbranding review on identifying names that overstate the efficacy or safety of the drug, expand drug indications, suggest superiority without substantiation, or are of a fanciful nature that misleadingly implies unique effectiveness or composition,” according to the notice.
The OPDP study will show 500 consumers and 500 healthcare providers pretested and extreme names (e.g., CureAll) and neutral names, plus five target names to be tested for the indications of high cholesterol and gastroesophageal reflux disease. These individuals then will be asked to answer questions about the names of drugs before knowing their indications.
“To our knowledge, this study is the first to provide a systemic investigation of a variety of proprietary prescription drug names,” the notice states.