OTC Umbrella Branding Soaked By Regulatory Storm In Draft Guidance – CHPA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 FDA’s draft guidance also renders useless OTC manufacturers’ expertise in conducting tests to determine whether consumers safely self-select nonprescription drugs based on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FDA granted CHPA request for more time to comment on December draft guidance, “Developing Proprietary Names for Human Nonprescription Drugs.” CHPA said industry is conducting an ‘in-depth’ review of the principles of the draft.
US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.
Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.