The panel's activities are managed by a consultant on a fee-for-service basis. The interested excipient manufacturer, through
direct discussions with the consultant, provides the consultant with a table of contents and summary of the expected studies
needed for the review. The consultant then provides a cost proposal and timeframe based on the expected time of review and
the experts' hourly fees. After the evaluation, the consultant provides the manufacturer with a report. The report can be
included in the sponsor's DMF or given directly to the drug product applicant.
IPEC only tracks the number of completed reviews and plays no role in this process. IPEC does not know any of the specifics
of an expert panel project. The evaluation procedure is kept confidential between the panel and sponsor.
FDA'srole
The details of this process were developed in conjunction with FDA staff, who, in a 2006 letter to IPEC, agreed to consider
the panel's conclusions when reviewing "new" excipients within NDAs. Although the agency could not guarantee that they would
agree with the panel's conclusions, they welcomed the additional level of review and acknowledged the value of the process
for encouraging new excipient development.
Conclusion
To date, IPEC's New Excipient Evaluation Procedure panel has received one submission and several others are in the planning
stages. The panel represents a potential remedy to the regulatory "logjam" facing new excipient development. The panel's independent
review should provide pharmaceutical manufacturers confidence that specific "new" excipients will be acceptable in their regulatory
filings, thus encouraging them to use these excipients in their formulations.
Christopher C. DeMerlis is manager of regulatory affairs at Colorcon and chair of the IPEC–Americas Regulatory Affairs Committee. Jay M. Goldring, PhD, is director of toxicology at Wyeth Consumer Healthcare and chair of the IPEC-Americas Safety Committee. David R. Schoneker is director of global regulatory affairs at Colorcon. and chair of IPEC–Americas. For more information, contact Alan Mercil
at IPEC–Americas, 1655 North Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.875. 2127, fax 703.525.5157, info@ipecamericas.org
http://www.ipecamericas.org/index.html.
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