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Matter Number
Docket Number
FDA-2013-D-1543 [80 Fed. Reg. 52296 (Aug. 28, 2015)]


FTC staff submitted a comment to the FDA, in response to the FDA’s request for comment on its draft guidance addressing nonproprietary names for biological products. The comment expressed concern that the FDA draft guidance might hinder competition, and recommended that the agency consider alternatives. In particular, the comment suggested that the FDA’s proposal to add a new, random suffix to the nonproprietary name of each biological product might cause physicians to believe mistakenly that the products necessarily have clinically meaningful differences, potentially resulting in reduced price competition in biologic drug markets, as well as unnecessary costs and conflicts with efforts toward global naming harmonization. The comment suggested alternatives that would have less impact on competition but could still achieve the FDA’s goals of improving pharmacovigilance, minimizing inadvertent substitution of biological products that the FDA has not determined to be interchangeable, and improving the reporting of adverse events involving biologics.