OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA
This article was originally published in The Pink Sheet Daily
The trade group recommends FDA write a separate proprietary name guidance for OTC drugs. FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on labeling, CHPA says in comments.
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FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”
FDA draft guidance on developing proprietary drug names recommends series of steps for sponsors to evaluate a proposed name; safety review includes testing name with healthcare professionals.
Critics of drug labels' effectiveness say reducing errors in the use of OTC drugs depends largely on a change manufacturers oppose - reining in umbrella branding