USP Submits Comments on Proposed Rule for Naming Certain Biologics

Changes to Established System Could Cause Unintended Consequences

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The United States Pharmacopeial Convention (USP) has submitted comments on the Food and Drug Administration’s (FDA) Proposed Rule, “Designation of Official Names and Proper Names for Certain Biological Products” (Proposed Rule).

At the heart of USP’s comments are three key principles.

For more than a century, USP’s monograph system has linked pharmaceutical names with key identity and quality attributes of all drugs, including biologics. Under this system, drugs that share the same identity share the same nonproprietary name. This system is based on science and is understood by practitioners, regulators and manufacturers all over the world.

There are other ways to address the FDA’s concerns that prompted the Draft Guidance and Proposed Rule without changing this simple, useful and well understood system. While USP supports FDA’s goals of enhancing pharmacovigilance and preventing medication errors, these could be achieved through changes to labeling or other means.

USP’s quality standards are critical to the federal drug regulatory framework. USP remains a committed partner with FDA, and will continue working with the FDA to improve drug quality and protect patients by maintaining the close link between drug naming and quality standards.

“Standards created by USP and its Council of Experts, consisting of expert scientific volunteers from academia, government and industry, are a critical part of the overall safety net that helps ensure the quality of our medicines and helps protect the patients who use them,” said Jaap Venema, Ph.D., Chief Science Officer and Executive Vice President of USP. “Useful, simple, concise and scientifically based names for drug substances and drug products help practitioners and patients use medications safely.”

Under the Proposed Rule, FDA seeks to designate nonproprietary names, including attaching distinguishing suffixes, for six specific biological products. The Proposed Rule implements the general approach set forth in FDA’s recently-released Nonproprietary Naming of Biological Products Draft Guidance for Industry.

The naming approach proposed by FDA could have far reaching consequences. Drugs that share identity but have different nonproprietary names in the US, and possibly yet another in the rest of the world, could introduce unintended consequences in the administration of healthcare, increasing complexity and ambiguity—potentially placing patients at risk. Healthcare practitioners must be able to easily read and understand the names of medications. Useful, simple, concise names help to minimize the potential for medication errors. USP has a long history of working with a naming system that practitioners understand and depend upon to make informed decisions when treating their patients.

USP and FDA share a common public health mission and the goal of improving patient safety across all medicines. USP is committed to this partnership with FDA and continuing to improve the quality of medicines.

USP’s full comment to the Proposed Rule is available by clicking  here



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