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H.R. 4404 (116th): Depression Side Effect Labeling Awareness Act of 2019


The text of the bill below is as of Sep 19, 2019 (Introduced). The bill was not enacted into law.


I

116th CONGRESS

1st Session

H. R. 4404

IN THE HOUSE OF REPRESENTATIVES

September 19, 2019

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).