116 HR 4404 IH: Depression Side Effect Labeling Awareness Act of 2019 U.S. House of Representatives 2019-09-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I116th CONGRESS1st SessionH. R. 4404IN THE HOUSE OF REPRESENTATIVESSeptember 19, 2019Mr. Rush introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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).