Section 1 Short title
This Act may be cited as the “Depression Side Effect Labeling Awareness Act of 2018”.
Depression Side Effect Labeling Awareness Act of 2018
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to require that the label of drugs with an increased risk of suicide or depression present such increased risk prominently, and for other purposes.
Sec. 2 Prominent drug labeling for increased risk of suicide or depression
In general— Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:
“(ee) If the warnings and precautions in the drug’s label include an increased risk of suicide or depression, unless such increased risk is presented prominently.”
Regulations— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall promulgate final regulations to carry out section 502(ee) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs.
Delayed applicability— Such section 502(ee) shall not apply until the Secretary of Health and Human Services has issued a final regulation under subsection (b).