USA – FDA Drafts Two New Guidances on Drug Labeling

The US Food and Drug Administration (FDA) on Monday released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling and another on the content and format of the Instructions for Use (IFU) of a medicine.

For the 12-page draft guidance on the “Drug Abuse and Dependence” section, FDA says the section should be concisely and clearly written to summarize the product’s “abuse potential, signs and symptoms of withdrawal, and abuse-deterrent properties (if applicable) and to provide information that is important for the safe and effective use of the product.”

The section is composed of three subsections, described in depth in the draft: (1) Detailing if the drug is a controlled substance, if the DEA scheduling is still pending and what the active ingredient is; (2) Abuse, misuse and addiction information; (3) Dependence information, with information on physical dependence and withdrawal.

The draft guidance also discusses the formatting of the “Drug Abuse and Dependence” section and what not to include (i.e. speculative or promotional language, information on the disposal of controlled substances or lengthy definitions).

“Our goal is that this guidance will help ensure that information in product labeling on abuse, misuse, addiction, physical dependence and tolerance is clear, concise, useful and informative,” Acting FDA Commissioner Ned Sharpless said in a statement that also points to the need for such clear labeling in opioid products…