The United States Pharmacopeial Convention (USP) has submitted its comments on the Food and Drug Administration’s (FDA) draft guidance, “Nonproprietary Naming of Biological Products: Guidance for Industry” (Draft Guidance). The Draft Guidance describes FDA’s proposal that all biological products bear a nonproprietary name that includes a manufacturer-specific FDA-designated suffix.
USP acknowledges FDA’s efforts to advance the successful implementation of the Biologics Price Competition and Innovation Act (BPCIA). “We understand the naming approach for biologics in the Draft Guidance reflects FDA’s interest in preventing inadvertent substitution of and facilitating pharmacovigilance for biological products,” said Jaap Venema, Ph.D., Executive Vice President and Chief Science Officer of USP. “At the same time, USP believes it is critically important to maintain a uniform and scientifically-based approach that does not create unintended risks for patients and practitioners, and encourages FDA to consider alternative solutions to reach its goals.”
Throughout its nearly 200-year history, USP has helped ensure that the medicines patients receive are of high-quality, safe and effective. USP achieves this through its legally-recognized role in setting scientifically-based public standards for identity, purity, quality and strength, as well as standards for packaging and labeling. As part of USP’s legally mandated role, the organization is part of a well-established drug naming system, which includes the naming of biologics. USP remains committed to fulfilling this role.
USP’s comment to the FDA’s draft guidance highlights the following key concepts:
- USP has a long history of setting quality standards for biologic drug substances and products;
- the existing scientifically-based nonproprietary naming system for biologics and other drugs has served patients and practitioners well for over a century;
- the naming approach proposed in the Draft Guidance represents a departure from well-established scientific naming principles and could have unintended negative consequences; and
- while USP shares FDA’s goal of improving safe medication use, USP encourages FDA to consider alternative solutions to achieve this goal.
Along with the Draft Guidance, FDA has issued a Proposed Rule, “Designation of Official Names and Proper Names for Certain Biological Products,” that sets forth proposed names for six products based on the naming convention outlined in the Draft Guidance. USP will be commenting separately on the Proposed Rule.
For USP’s full comment to the Draft Guidance, click here