I
119THCONGRESS
1
STSESSION H. R. 1117
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
to-consumer drug advertising.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY7, 2025
Ms. D
ELAUROintroduced 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
restrict direct-to-consumer drug advertising.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Responsibility in Drug 4
Advertising Act of 2025’’. 5
SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 6
The Federal Food, Drug, and Cosmetic Act (21 7
U.S.C. 301 et seq.) is amended— 8
(1) in section 301 (21 U.S.C. 331), by adding 9
at the end the following: 10
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‘‘(jjj) The conduct of direct-to-consumer advertising 1
of a drug in violation of section 506M.’’; and 2
(2) in chapter V, by inserting after section 3
506L (21 U.S.C. 356l) the following: 4
‘‘SEC. 506M. DIRECT-TO-CONSUMER DRUG ADVERTISING. 5
‘‘(a) P
ROHIBITIONS.— 6
‘‘(1) F
IRST 3 YEARS.— 7
‘‘(A) I
N GENERAL.—Subject to subpara-8
graph (B), no person shall conduct direct-to- 9
consumer advertising, including on a social 10
media platform, of a drug approved under sec-11
tion 505(c) before the end of the 3-year period 12
beginning on the date of such approval. 13
‘‘(B) W
AIVER.—The Secretary may waive 14
the application of subparagraph (A) to a drug 15
during the third year of the 3-year period de-16
scribed in such subparagraph if— 17
‘‘(i) the sponsor of the drug submits 18
an application to the Secretary pursuant to 19
subparagraph (C); and 20
‘‘(ii) the Secretary, after considering 21
the application and any accompanying ma-22
terials, determines that direct-to-consumer 23
advertising of the drug would have an af-24
firmative value to public health. 25
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‘‘(C) APPLICATION FOR WAIVER .—To seek 1
a waiver under subparagraph (B), the sponsor 2
of a drug shall submit an application to the 3
Secretary at such time, in such manner, and 4
containing such information as the Secretary 5
may require. 6
‘‘(2) S
UBSEQUENT YEARS .—The Secretary may 7
prohibit direct-to-consumer advertising, including on 8
social media platforms, of a drug during the period 9
beginning at the end of the 3-year period described 10
in paragraph (1)(A) if the Secretary determines that 11
the drug has significant adverse health effects based 12
on post-approval studies, risk-benefit analyses, ad-13
verse event reports, the scientific literature, any clin-14
ical or observational studies, or any other appro-15
priate resource. 16
‘‘(b) R
EGULATIONS.—Not later than 1 year after the 17
date of the enactment of this section, the Secretary shall 18
revise the regulations promulgated under this Act gov-19
erning drug advertisements to the extent necessary to im-20
plement this section. 21
‘‘(c) R
ULE OFCONSTRUCTION.—This section shall 22
not be construed to diminish the authority of the Secretary 23
to prohibit or regulate direct-to-consumer advertising of 24
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drugs, including on social media platforms, under any 1
other provision of law. 2
‘‘(d) E
FFECTIVEDATE.—This section applies only 3
with respect to a drug approved under section 505(c) on 4
or after the date that is 1 year before the date of enact-5
ment of this section.’’. 6
Æ
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