All proposed proprietary names for human medicinal products go through a misbranding or promotional review. Specifically, the FDA’s Office of Prescription Drug and Promotion (OPDP) will review a name to determine if the name conveys a message that is misleading or confusing in nature.
Name safety testing should incorporate the following concepts to further evaluate a name for a promotional claim:
- Prescribing Intent
- Effectiveness
- Safety
- Superiority Claim
From a European perspective, according to the latest Guidance from the European Medicine’s Agency (EMA) (Revision 7) section 4.1.8 “the (invented) name of a medicinal product should not convey a promotional message. An (invented) name is considered promotional if it is overly fanciful, so as to misleadingly imply unsubstantiated unique effectiveness, composition or superiority claims, if it overstates the product efficacy, minimizes the risk or broadens the product indications.”
We don’t want to oversimplify this review – but in general, the (invented) name cannot suggest or say anything that is not true about the product and cannot cause confusion or be misleading.
If you are conducting name safety testing on your brand names, it is not sufficient to simply ask whether the name conveys a message about the product. The reviewer must go a step further and ask whether the information conveyed is either misleading or would cause confusion in practice.
Here are just a few of the questions incorporated into the SafeMark Model to start the evaluation of a new brand name:
1. Does the name contain any medical terms or abbreviations?
2. Does the name suggest a manufacturer?
3. Does the name contain any words or letter strings that suggest the product’s route of administration, dosage form or frequency of administration?
4. Does the name relate to the product’s indication or patient population?
5. Does the name contain a letter string already associated with a marketed product?
6. Does the name suggest any of the following types of messages: prescribing intent, efficacy or superiority?
If you want to learn more, please visit our website at www.brandsymbol.com