FDA releases draft paper on pilot program for drug naming

WASHINGTON The Food and Drug Administration has released a draft paper stating some of the concepts the agency is considering for a new two-year pilot program beginning in 2009 that will solve the problems of similar sounding drugs on and about to reach the market. The FDA is releasing the paper in advance of a public meeting scheduled to discuss the topic on June 5 and 6.

The pilot program will be designed to allow drug companies to volunteer to evaluate proposed proprietary names and submit the data for review to the Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research, as appropriate. In the pilot program, CDER and CBER will evaluate the safety and promotional implications of submitted drug names. If a name seems prone to cause confusion, the relevant center “will not recommend its approval for use in the market and will request the applicant propose an alternate name for evaluation,” the draft says. “Any preventable risk of error that can be identified prior to drug approval should be addressed.”

For example, applicants are advised to avoid proprietary names that incorporate or suggest a dosing interval or dosage form since these may change, use common medical abbreviations or coined abbreviations, or include or suggest the composition of the drug product.

The June 5–6 meeting will address the pilot program and developments in the science and practice of proprietary name analysis since 2003, when the agency held two public meetings on the subject. Also on the agenda will be the strength of evidence for the agency’s approach to reviewing the names of prescription and nonprescription products and best practices in the absence of a gold standard.