FDA to Hold Public Meeting on the Evaluation of Trade Names
FDA recently announced that on June 5 and 6, 2008, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will hold a public meeting to discuss the Agency’s plans to launch a pilot program on the testing and review of proprietary names and the issuance of a concept paper that will describe the logistics of the pilot program, recommendations for implementing a proprietary name review, and the proposed review of submissions made under the pilot program. The pilot program will allow participating companies to submit data generated from their own testing and evaluation of proposed proprietary product names. FDA expects to issue the concept paper by the end of Fiscal Year (“FY”) 2008 and begin enrollment in the pilot program in FY 2009.
The pilot program and concept paper are intended to increase the transparency of FDA’s review process of proprietary names and to decrease the risk of medication errors. Currently, FDA reviews proprietary names to determine any promotional or safety issues. For example, FDA considers whether a proposed name overstates the efficacy of the drug product, minimizes the drug product’s risks, or broadens its indications. FDA also considers whether the name is spelled similarly or sounds similar to another marketed product or could otherwise cause confusion, such as having similar abbreviations. The current safety review expands the entire medication process, taking into consideration, for example, errors that could arise during the procurement, prescribing, ordering, dispensing, and administration of a drug.
Under the performance goals FDA agreed to as part of the recent reauthorization of the Prescription Drug User Fee Act (i.e., PDUFA IV), the Agency committed to implement various measures with respect to proprietary name review in an attempt to reduce medication errors. These measures include meeting certain proprietary name review performance goals (beginning in FY 2009) during the IND and NDA/BLA review phases, publishing guidance and policy procedures on proprietary name review and best practices, developing and implementing a pilot program “to enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and submit the data generated from those evaluations to the FDA for review,” and “exploring the possibility of ‘reserving’ proprietary names for companies once the names have been tentatively accepted by the Agency.” FDA’s June 2008 meeting is part of the Agency’s efforts to meet these goals. FDA’s efforts also respond to calls for more industry involvement in the proprietary name testing process, including requests made in reports by the Institute of Medicine in 2006 and 1999 and recommendations made by the Health and Human Services Advisory Committee on Regulatory Reform in November 2002.
During the meeting, FDA plans to discuss the following key issues: (1) best practices in safety and promotional testing of proprietary names; (2) testing procedures that should be used and data that should be submitted by those participating in the pilot; (3) standardization of testing; (4) criteria to consider in evaluating the testing and data submitted; (5) the structure and evaluation of the pilot program; and (6) any public health concerns raised by the pilot program. FDA will use the information gathered from the meeting and from comments submitted to the docket to develop the concept paper and the pilot program.
The meeting will be held from 8:30 a.m. to 5:00 p.m. each day at the Crowne Plaza Hotel in Silver Spring, Maryland. Information on meeting attendance and registration is provided in FDA’s Federal Register notice announcing the meeting. Written comments regarding the concept paper and pilot program must be submitted by July 6, 2008 to the Division of Dockets Management or electronically at www.regulations.gov.
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