Depression Side Effect Labeling Awareness Act of 2018 (HR 6717, 115th Congress)

Policy Details

Policy Details

Originating Entity
Last Action
Referred to House Committee
Date of Last Action
Sep 6 2018
Congressional Session
115th Congress
Date Introduced
Sep 6 2018
Publication Date
Oct 19 2018

SciPol Summary

Section 502 of the Federal Food, Drug, and Cosmetic Act contains provisions which discuss misbranding in the context of false or misleading labeling. The Depression Side Effect Labeling Awareness Act of 2018 (HR 6717) will amend this section to require more prominent labeling of drugs that may have the side effect of increasing the patient’s risk of suicide or depression. Furthermore, HR 6717 directs the Department of Health and Human Services (HHS) to implement final regulations pertaining to section 502 of the Federal Food, Drug, and Cosmetic Act within one year following enactment. Prior to publicizing final regulations HHS should consult with stakeholders in the process (most notably, pharmaceutical manufacturers).

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