H.R. 4404 — Introduced in House

I 116th CONGRESS 1st Session H. R. 4404 IN THE HOUSE OF REPRESENTATIVES September 19, 2019Mr. Rush introduced the following bill; which was referred to the Committee on Energy and Commerce 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. 1. Short title This Act may be cited as the Depression Side Effect Labeling Awareness Act of 2019. 2. Prominent drug labeling for increased risk of suicide or depression (a) 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. . (b) 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. (c) 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).