Policy on Requests for an Additional Round of Negotiation
In recent years, requests for additional rounds of USAN Council (USANC) balloting from manufacturers and their consultants have increased dramatically. Often these requests are sent to the USAN Secretariat without adequate data or substantial rationale for requesting an additional round of balloting.
Please be reminded that the purpose of USAN is to provide health professionals with a simple, informative and unique nonproprietary name obtained from logical nomenclature classifications based on pharmacological and/or chemical relationships.
To avoid misunderstandings and lengthy USAN processing delays, the following policy offers clarification for manufacturers and their representatives.
- An additional round of balloting or a request that the USANC reconsider a request must be accompanied by a clear rationale based on new information (such as new research results or patient safety data) that has not been sent to the USAN Secretariat in the past. Recapitulations or summaries of data that originally accompanied the USAN application will not be accepted as new information.
- A request for an alternative prefix to the one recommended by the USANC in a previous round must be accompanied by the reason(s) the applicant has rejected the USANC's prefix recommendation. The manufacturer's rationale for rejection will be taken into account when the USANC determines whether or not an alternative prefix should be assigned. Please note that suggestions for alternative prefixes which imply directly or indirectly, a specific quality or attribute, will not be considered by the USAN Council.
- Past USANC decisions (the citing of USAN designations occurring in past years as precedent) in the absence of new, additional data will not constitute adequate rationale for an additional round of balloting.
Failure to meet the policies above by the manufacturer or manufacturer's consultant/representative will prevent the additional balloting round request from being forwarded to the USANC.