[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4404 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 4404

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 19, 2019

   Mr. 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Depression Side Effect Labeling 
Awareness Act of 2019''.

SEC. 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).
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