Health Canada Sharpens Regulatory Requirements for Naming

FDA Health Canada

Name Challenges in Pharmaceutical Brand Naming

The pharmaceutical market is highly regulated. Not only are there laws to restrict the information that is being spread to the public as with the HWG-law in Germany (Heilmittelwerbegesetz), but there are also guidelines for naming that tell you exactly what needs to be taken into account, and more importantly, what needs to be ruled out. Two main principles are that the name may not include a promotional message of any kind like “QuickestDrug”, and that it should not be misleading. In this context “misleading” means that the name should not suggest that the pharmaceutical can be indicated for a certain disease or dysfunction for which it, in fact, is not. For example, “Coughinex” for a medication against sleep disorder would not work. Apart from those two rules, many others exist that naming agencies, that are focused on pharmaceutical naming, need to be aware of. The overall objective is to have clear, suggestive and easily-pronounceable names, which contribute to patients’ safety by eliminating confusion.

The Strictest Regulations – FDA and Health Canada

Most countries have such a guideline that regulates naming requirements. Two crucial countries are the USA with the regulatory authority FDA and Canada with Health Canada. Both regulatory authorities require a name testing with doctors and HCPs. Health Canada has just announced that they have sharpened their requirements and strongly recommend a larger sample size of doctors. This will apply from the middle of the year 2015. The simulation tests with HCPs are designed to minimize the risk of confusion orally (pronunciation and verbal understanding) as well as orthographically.

Patients as Target Group

Besides the regulatory issues and the target group, advertising is designed quite differently. This is due to the fact that the pharmaceutical industry does not and/or should not push the product to the consumers. Instead it is strived that the consumers know the name of the product when they need it, in other words, in the instance that they are ill. Therefore, advertising is less straight-forward than that of FMCGs. The right balance needs to be found.

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  1. Ronald A. Rader

    It should be noted that there are many types of drug names, both for finished products and their active agents. This article is referring to what in the U.S. are established names, the short non-proprietary, usually meaningless in themselves (to meet the described linguistic requirements) and provided as INN/USAN names, with these names assigned by government edict as the public/non-proprietary name to be used by the manufacturer/marketer in its product labeling, marketing, etc. These names are furthe essentially automatically (without any critical thought) adopted by many others as the names they use for finished products; and with absolute ambiguity, the same names are used for the active agents (which is actually what the names are assigned to, then by gov’t edict declared to be the official non-proprietary names).

    In my area, biopharmaceuticals, these names are currently a major issue in the U.S, with FDA overdue by years to issue guidelines or regulations concerning biosimilars naming, which really involves nomenclature for all biopharmaceuticals. Even when FDA rules on this, that will not fix any of the nomenclature problems with biologics/biopharmaceuticals, with these established, INN/USAN-type short names rather useless for all but what they are designated for, i.e., for anything beyond broad product marketing, names to be used for writing prescriptions, etc. There still will be a need for both genuine unique/distinct and generic/class names for biopharmaceuticals, with these simply not yet existing.

    I have filed a Citizen Petition with FDA demanding the agency assign actual unique/distinct names (or other identifiers) and biosimilar/(bio)generic names/identifiers for both finished products and active agents. Effective communications simply demands this. Otherwise, there is no way to either specifically or generically refer to these products. See (in the 2nd section) regarding the Petition. This site also has much other information about biopharmaceutical-related nomenclature issues.

  2. Manuela Maus

    Dear Ronald,

    Thank you for your very interesting contribution.

    True. On the one hand, there are international non-proprietary names (the names for active ingredients) that are regulated by the WHO and/or the FDA. On the other hand, there are proprietary names (brand names by the pharmaceutical manufacturers). The article refers to brand names for which naming guidelines by the regulatory authorities also need to be respected. Existing brand names like Revaxis, Ameluz and Belixos were also tested for their regulatory conformity to prevent medication errors.
    Yet, some criteria for names like easy pronunciation and distinctness do also apply to INNs/USANs.

    I absolutely agree with you that also for biosimilars a distinct, unique brand name that is easy to pronounce and write, when prescribed, is necessary for effective communication. With regards to FDA’s consideration of changing the INN/USAN nomenclature logic for biosimilars and define a unique “generic” name, I assume that this will lead to several problems such as confusion among doctors as they may not recognize that two biosimilars are actually the “same product”. Nonetheless, I completely understand why the FDA considers changing the system. A biosimilar is not equal to a generic in a sense. However, a good solution would be to add a descriptor or suffix to the non-proprietary names of the original biopharmaceutical to indicate the product being a biosimilar, as proposed by the WHO. The WHO suggests to add a 4-letter “stamp” as a descriptor.

    We are waiting for FDA’s naming draft – watch this space!

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