I 
114TH CONGRESS 
2D SESSION 
H. R. 4565 
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- 
to-consumer drug advertising. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 12, 2016 
Ms. DELAURO 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 
restrict direct-to-consumer drug advertising. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Responsibility in Drug 
Advertising Act of 2016’’. 
SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended— 
(1) in section 301 (21 U.S.C. 331), by adding 
at the end the following: 
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‘‘(eee) The conduct of direct-to-consumer advertising 
of a drug in violation of section 506G.’’; and 
(2) in chapter V, by inserting after section 
506F (21 U.S.C. 356f) the following: 
‘‘SEC. 506G. DIRECT-TO-CONSUMER DRUG ADVERTISING. 
‘‘(a) PROHIBITIONS.— 
‘‘(1) FIRST THREE YEARS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), no person shall conduct direct-to- 
consumer advertising of a drug for which an 
application is submitted under section 505(b) 
before the end of the 3-year period beginning 
on the date of the approval of such application. 
‘‘(B) WAIVER.—The Secretary may waive 
the application of subparagraph (A) to a drug 
during the third year of the 3-year period de-
scribed in such subparagraph if— 
‘‘(i) the sponsor of the drug submits 
an application to the Secretary pursuant to 
subparagraph (C); and 
‘‘(ii) the Secretary, after considering 
the application and any accompanying ma-
terials, determines that direct-to-consumer 
advertising of the drug would have an af-
firmative value to public health. 
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‘‘(C) APPLICATION FOR WAIVER.—To seek 
a waiver under subparagraph (B), the sponsor 
of a drug shall submit an application to the 
Secretary at such time, in such manner, and 
containing such information as the Secretary 
may require. 
‘‘(2) SUBSEQUENT YEARS.—The Secretary may 
prohibit direct-to-consumer advertising of a drug 
during the period beginning at the end of the 3-year 
period described in paragraph (1)(A) if the Sec-
retary determines that the drug has significant ad-
verse health effects based on post-approval studies, 
risk-benefit analyses, adverse event reports, the sci-
entific literature, any clinical or observational stud-
ies, or any other appropriate resource. 
‘‘(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this section, the Secretary shall 
revise the regulations promulgated under this Act gov-
erning drug advertisements to the extent necessary to im-
plement this section. 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed to diminish the authority of the Secretary 
to prohibit or regulate direct-to-consumer advertising of 
drugs under other provisions of law. 
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‘‘(d) EFFECTIVE DATE.—This section applies only 
with respect to a drug for which an application submitted 
under section 505(b) is approved on or after the date that 
is 1 year before the date of the enactment of this section.’’. 
Æ 
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