Pfizer and Janssen said the FDA’s draft guidance on drug abuse and dependence labeling for prescription drugs and biologics is good but needs some tweaking.
The guidance, which came out in July, includes general principles for drug applicants on writing the drug abuse and dependence section of labeling, including terminology and suggestions for formatting. The agency said sponsors should include information on a product’s potential for abuse, the signs and symptoms of withdrawal, and any abuse-deterrent properties.
Pfizer suggested that information on misuse get its own section in the guidance if the agency is looking to differentiate between misuse and abuse. Currently, the information on misuse is in a subsection on abuse.