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FDA’s Burden Estimate On Biologic Naming Ignores Downstream Costs, Critics Say

 
• By Sue Sutter

Costs across the US healthcare system of implementing new suffix-based nomenclature could reach into the billions, stakeholders say in requesting the Office of Management and Budget delay implementation of FDA’s final guidance on nonproprietary naming of biologics pending further analysis.

Complaints that the US FDA’s burden estimates for implementing a suffix-based nonproprietary naming system for all biologic products failed to take into account hundreds of millions of dollars in downstream costs may find a receptive audience in the Trump Administration.

Several stakeholders have requested the Office of Management and Budget (OMB) delay implementation of the suffix-based naming policy outlined in...

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