'CurAll' or 'Bestmab': FDA to Study How Proprietary Names Affect Perceptions

Regulatory NewsRegulatory News | 17 January 2020 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is planning a study to investigate how proprietary drug names affect consumers’ and/or healthcare providers’ perceptions and whether they might overstate the efficacy of a drug.

During FDA’s prescription drug approval process, sponsors propose proprietary names for their products, which are reviewed by the Office of Drug Safety, the relevant medical office and OPDP. OPDP reviews names to assess for alignment with the FD&C Act, which provides 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. While there are several ways proprietary names can be misleading, this research will primarily focus on overstatement of the efficacy of the drug product,” FDA says.

Recently approved drugs with names that might not seem as random as others (like Xcopri or Egaten) include Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel) or Protein Sciences’ flu vaccine Flublok or AstraZeneca’s treatment for unresectable or metastatic HER2-positive breast cancer Enhertu (fam-trastuzumab deruxtecan-nxki).

In the proposed study, OPDP will select approximately 500 consumers from the general population and 500 health care providers (including physicians, nurse practitioners, and physician assistants) and provide them with pretested extreme and neutral names plus five target (to be tested) names per indication and have them answer questions about the names, before and after they have been told what each drug’s indication is.

“Target names will vary such that some efficacy implications are more apparent than others and some will more clearly imply indication or benefits than others. Dependent variables will include indication identification, efficacy, and perceptions,” FDA says. “To our knowledge, this study is the first to provide a systemic investigation of a variety of proprietary prescription drug names.”

FDA is no stranger to naming controversies.

When the agency decided to make the US the first country in the world to use suffixes with biosimilars’ non-proprietary names, FDA began by using a meaningful suffix (with the approval of Sandoz's biosimilar Zarxio (filgrastim-sndz)), then reversed course and proposed that sponsors would submit up to 10 nonsense proposed suffixes, "in the order of the applicant's preference," and then withdrew that plan and stuck with nonsense suffixes.

The agency also began adding suffixes to already approved biologics’ names, so it would not seem like products with suffixes were inferior to those without them, but then the agency decided last May not to proceed with that plan.

In addition to the work on studying names and perceptions, the agency also said in August that it’s studying health care providers’ awareness, perceptions and beliefs about the benefits and risks of an FDA-approved product that carries a boxed warning.

Federal Register


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