FDA to Emphasize Safety in Approving Drug Names

July 31, 2008

The way in which the FDA approves proposed drug names is changing as the agency increases its focus on drug safety through preventing medication errors.

The Division of Medication Error Prevention (DMEDP) is taking the lead in regulatory actions related to proprietary name review and medication error prevention, Susan Proulx, president of Med-ERRS, said at an FDAnews audioconference last week.

Previously, DMEDP checked proposed drug names to see if they were similar enough to existing drug names to potentially cause medication errors. It then issued a recommendation to the relevant drug-reviewing division, which could overrule it.

Under a memorandum of agreement signed this month between the FDA’s Office of New Drugs and Office of Surveillance and Epidemiology (OSE), “there will be more transparency, and DMEDP will have more say,” Proulx said.

DMEDP may get the final say on whether a proposed drug name can be approved rather than the reviewing division, she added. The goal is to improve drug safety by decreasing the risk of medication errors caused by name confusion.