FDA hearing to be held on drug name review procedures

WASHINGTON On June 5 and 6, the Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are holding a public technical meeting in preparation for a pilot program to allow pharmaceutical companies to evaluate proposed propriety names and submit data generated from those evaluations to the agency for review.

The purpose of the meeting is to discuss a method for companies to carry out a proposed drug name for review and also how the FDA intends to review the submissions under the program.

The reason for the meeting dates back five years ago, when the agency started discussing medication errors as a result of patients taking medications with similar names to the drugs they were supposed to be taking.

The goal is to issue a concept paper by the end of this fiscal year and for enrollment to begin for the pilot program in fiscal 2009.