Federal drug regulators plan to launch a study focusing on how consumers and healthcare providers perceive new drug names, amid continuing concerns about the risk of medication mistakes and confusion.
In a Federal Register Notice posted January 21, the FDA announced the launch of a study focusing on how drug names affect consumers and doctors. Researchers want to know if a brand name can affect how consumers and healthcare providers view a drug’s effectiveness.
FDA researchers will ask 500 consumers and 500 healthcare providers, including doctors, nurses, and physician assistants, to answer questions about seven different drugs and the proposed names.
The names will include pretested extreme names, neutral names, and five target (to be tested) names. Participants will answer questions before and after they are told what the drug’s is intended to treat. The study will be conducted by the Office of Prescription Drug Promotion (OPDP) and is reportedly the first of its kind.
Some of the names will be an “extreme, explicitly suggestive” name like “CureAll” and another will be purposefully neutral. Researchers want to see whether drug names that overstate the efficacy affects consumer perception.
The typical naming process involves drug makers submitting their proposed names to the FDA for approval. Often, manufacturers will hire branding agencies to help create a name that helps patients and doctors draw relevant connections to what the drug does.
However, there are FDA naming guidelines that must be followed. For example, pharmaceutical companies cannot use names that specify a drug’s attributes. They also cannot use names that are too similar to those already on the market.
OPDP also focuses on reviewing names that overstate efficacy or safety of the drug, suggest superiority without substantiation of the superiority, or are fanciful in nature, which can imply unique effectiveness that other drugs don’t feature.
The new study will focus on target names that vary in ways that the efficacy of the drug may be more apparent by some names than others, or will clearly imply an indication or benefits compared to others.
The FDA hopes knowing how consumers and healthcare providers perceive these differences will help the agency with how it regulates drug naming going forward.
Public comment for the study proposal will be open until March 23, 2020. Details on submitting public comment are detailed in the Federal Register notice.
Tags: Drug Advertising