How To Manage A Rebuttal

Posted July 10, 2017 by
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Pharmaceutical companies and their branding agency partners face many difficult questions while undertaking a product naming initiative. Whether it is a small, emerging biotech naming their first compound, or a massive pharmaceutical Company undergoing their fifth naming project of the year, questions like these will always need clear, consistent, and compelling answers: What message should the name convey? What will set this name apart? How will the name resonate with audiences? And, perhaps most importantly in the pharmaceutical space, how will my name fare under safety and regulatory scrutiny for multiple global regulatory bodies?

Every drug in the pharmaceutical industry has at least three names. There is a chemical name based on its compound structure, the nonproprietary name, and the Brand (proprietary) name utilized and owned by the pharmaceutical Company. Drug Brand names are created based on any number of characteristics (i.e., mechanism of action, therapeutic area, route of administration, unique benefit), and all must be submitted to the regulatory bodies where it will be sold, which could include: Food and Drug Administration (FDA), Health Canada, European Medicines Agency (EMA), Ministry of Health, Labour and Welfare in Japan; for promotional and safety review and final approval.

This is no simple task. First a Proprietary Name Assessment (PNA) is submitted which includes a comprehensive overview, the research methodology that was utilized for testing with results, a Risk Assessment inclusive of Failure Mode Effects Analysis (FMEA) testing results, Phonetic and Orthographic Computer Analysis (POCA), and cross-profile analysis against any other somewhat similar name and linguistics review. In addition, any possible red flags the FDA should consider when deciding on the approval will be noted in the PNA.

The risk assessment outlines the safety research and the Brand name participation evaluation, both of which are ultimately forwarded to the particular regulatory body for recommended approval. The names that could be identified based on likelihood of confusion will be included, along with exhaustive POCA searches. The degree of similarity for each name in relation to another already on the market is tested. And finally, the potential risk of harm is considered with the FMEA and other tests.

Some reasons for an FDA rejection include a poor promotional review, likelihood of confusion, and degree of similarity to other names in the marketplace. Should a Brand name be rejected, a Company is left with two options: 1) they can submit a backup name which may mean going back to the “drawing board,” which will likely delay their product launch schedule and commit more valuable budgets; or 2) they can attempt an official rebuttal of the FDA’s decision.

Let’s say the FDA rejects a name due to degree of similarity with another drug on the market: The process for an official rebuttal would include a new submission cover letter, referencing the issues previously cited by the FDA, with each reference accompanied by a response backed up with research. In this case, research could cite other examples of similar drugs on the market that do not have misprescription errors, or reference the drugs route of administration as possible differentiators that would allow for the name to be approved. Companies rely heavily on branding agencies and their safety partners when making the decision whether or not to ask for reconsideration for the name with an official rebuttal.

Once the rebuttal is submitted there is no predetermined timeline in the guidelines for a turnaround. The conservative estimate on time is based on where the compound is in the Investigational New Drug (IND) and New Drug Application (NDA) stage and if the FDA correspondence regarding the rebuttal provides any specific timelines.

The rebuttal process is complex, and something that any Company beginning a new pharmaceutical naming project should be comfortable that their agency partner can handle should the need arise. Because of the extreme complexity of the safety and regulatory stipulations in the space, having an agency partner with a proven track record of backup naming to go along with experience in, and success with, the rebuttal process will prove invaluable.

Tags:

Branding | Pharmaceutical Naming | Rebuttal | Regulatory | Safety

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