Biosimilar Nomenclature and Some FDA Tea Leaves

  • by: |
  • 07/25/2014

Per the debate over biosimilar nomenclature --Did somebody say distinct drug names assist in the reduction in medication errors?

Yes – and that somebody is the FDA.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1008]

Exploring the Possibility of Proprietary Name Reservation for Drug Products;

Establishment of a Public Docket

SUMMARY: The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of “reserving” proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.

Link to Federal Register Notice: https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-17691.pdf

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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