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# Abuse, Dependence Labeling Comments
- URL: https://www.fdaweb.com/abuse-dependence-labeling-comments/
- Published: 2019-09-10T12:00:00.000Z
- Updated: 2026-09-15T01:48:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144955

Pfizer says it supports FDA’s recommendations for general principles to consider when drafting the drug and abuse and dependence section of prescription drug labeling and the information that should be included. Responding to an FDA draft guidance on the subject, the company [says](https://www.regulations.gov/document?D=FDA-2019-D-1917-0004&ref=fdaweb.com) that it finds the standard language in section 9.1-9.3 to be helpful. It also says there are areas that would benefit from additional information or clarification.

GlaxoSmithKline [says](https://www.regulations.gov/document?D=FDA-2019-D-1917-0003&ref=fdaweb.com) some of the new content requested in the draft guidance related, for example, to misuse and addiction, may be class labeling language and the agency may consider developing class labeling text, where appropriate, to facilitate an efficient and consistent implementation of the new guidance across labels. The company also says that information on how and when the agency plans to implement the guidance would be helpful.

Finally, Janssen [says](https://www.regulations.gov/document?D=FDA-2019-D-1917-0005&ref=fdaweb.com) the draft guidance provides useful information to drug sponsors but could be improved in some respects. The company says a general concern throughout the document relates to the terminology it uses. It asks that FDA modify terminology in the draft to conform to usage in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders. And it asks for clarification on how the approaches outlined in the draft guidance for the package insert apply to patient labeling and to carton and container labels.

All three letters include line-by-line specific comments.