FDA Draft Guidance Seeks to Improve Drug Abuse, Dependence Information in Labeling

The Food and Drug Administration (FDA) is looking to make the information in the Drug Abuse and Dependence section of product labeling more consistent and clear through a new draft guidance. 

The recommendations in the draft guidance are expected to ensure product labeling for drugs scheduled under the Controlled Substances Act (CSA), as well as other agents that may not be scheduled under the CSA but have abuse potential, contain language that is “clear, concise, useful and informative.” 

Changes to the labeling may include defining terms such as abuse, misuse, addiction, physical dependence and tolerance to reduce confusion or misinterpretation. “For example, a person who takes a friend’s prescription opioid medication to relieve tooth pain is misusing the medication; if that person takes a friend’s opioid to get a euphoric high, that use represents abuse of the medication,” the FDA noted in a press statement. 

In addition to this, a second draft guidance has been issued regarding recommendations for developing the content and format of an Instructions for Use (IFU) document. The IFU is for patients who use drugs that have complicated or detailed patient-use instructions; it is intended to provide clear and concise information for safe and effective use, including instructions on preparation, administration, handling, storage and disposal. 

“We encourage the public to comment on these draft guidances and will consider all comments as the agency works to finalize them,” said Acting FDA Commissioner Ned Sharpless, MD, and Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research.

For more information visit FDA.gov.