Side Effect Warning: FDA’s “Change of Formulation” to POCA Algorithm May Cause Headaches, Tiredness, and Blurry Vision

by Steve Anderson on Wednesday, 5 April, 2017

Back in late 2016, the US Food and Drug Administration (FDA) released a new version of the Phonetic and Orthographic Computer Analysis (POCA) program called POCA 4.0. For those of us in the pharmaceutical trademark clearance and/or branding industries, this sounded like a good thing.

Program version updates come with the expectation of improvement. The original POCA was released years ago, and while not perfect, it remains the pharma industry standard in terms of ranking pharmaceutical marks on name safety similarity to a proposed candidate. POCA isn’t a definitive tool, and it’s just one of many methods and tools in the FDA’s arsenal for determining name safety issues in the pharmaceutical industry.

The POCA 4.0 algorithm has indeed been dramatically changed from the original pre-4.0 version. According to the FDA, the orthographic component of the POCA algorithm was revised to better capture errors that are being reported due to the increased use of electronic prescribing. The algorithm has been revised to put more emphasis on the similarity that occurs at the beginning of a name — especially the first three letters and on exact letter matches — and also to emphasize where names share letters that are not consecutive.

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Topics: trademark, pharmaceuticals

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