What’s in a (drug) name? FDA to study how they affect efficacy perceptions
When it comes to proprietary drug names overstating their efficacy, tainted sexual enhancement products disguised as supplements may take the cake (see: “2 Own The Knight” or “XXXPlosion Ultra”).
For the legitimate pharmaceutical world, the FDA wants to take a closer look at how certain brand names affect consumer and health care providers’ perceptions about efficacy and the medical conditions for which they’re indicated.
The agency is preparing to conduct what it says is the first widespread study into proprietary prescription drug names. The plan is to look at the perceptions of 500 consumers and 500 health care providers on certain fictional names for two medical conditions — high cholesterol and gastroesophageal reflux disease.
The study will compare five target names that may just suggest a medical condition or vary in terms of how the name portrays a drug’s efficacy, with one name that explicitly suggests strong efficacy (CuresFlux) and one that is more neutral (Zerpexin).
Participants will 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 the medical condition for which a drug is indicated than others,” FDA said.
Already the agency has signed off on such proprietary names that suggest the medical condition (e.g. AstraZeneca’s HER2-positive breast cancer treatment Enhertu) or may not seem as random as others (e.g. Protein Sciences’ flu vaccine Flublok or Gilead’s CAR-T therapy Yescarta).
The agency on Monday offered more detail and responded to comments on how its study, first previewed in January 2020, will be conducted and why it’s looking into this issue.
“The purpose of the current study is to determine whether a proprietary name itself could play a role in influencing consumer and HCP [health care provider] perceptions of drug risks or benefits by suggesting the medical condition for which the drug is indicated or by suggesting an overstatement of the efficacy of the drug,” FDA said.
The agency further clarified that the purpose of including this “extreme” name, CuresFlux, is not to have data on names that won’t be used in the real world, 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.