I 

114TH CONGRESS 

2D SESSION H. R. 4565 

To amend the Federal Food, Drug, and Cosmetic Act to restrict directto-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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Responsibility in Drug 

5 Advertising Act of 2016’’. 

6 SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 

7 The Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 301 et seq.) is amended— 

9 (1) in section 301 (21 U.S.C. 331), by adding 

10 at the end the following: 


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1 ‘‘(eee) The conduct of direct-to-consumer advertising 

2 of a drug in violation of section 506G.’’; and 

3 (2) in chapter V, by inserting after section 

4 506F (21 U.S.C. 356f) the following: 

5 ‘‘SEC. 506G. DIRECT-TO-CONSUMER DRUG ADVERTISING. 

6 ‘‘(a) PROHIBITIONS.— 

7 ‘‘(1) FIRST THREE YEARS.— 

8 ‘‘(A) IN GENERAL.—Subject to subpara9 graph (B), no person shall conduct direct-to10 consumer advertising of a drug for which an 

11 application is submitted under section 505(b) 

12 before the end of the 3-year period beginning 

13 on the date of the approval of such application. 

14 ‘‘(B) WAIVER.—The Secretary may waive 

15 the application of subparagraph (A) to a drug 

16 during the third year of the 3-year period de17 scribed in such subparagraph if— 

18 ‘‘(i) the sponsor of the drug submits 

19 an application to the Secretary pursuant to 

20 subparagraph (C); and 

21 ‘‘(ii) the Secretary, after considering 

22 the application and any accompanying ma23 terials, determines that direct-to-consumer 

24 advertising of the drug would have an af25 firmative value to public health. 


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1 ‘‘(C) APPLICATION FOR WAIVER.—To seek 

2 a waiver under subparagraph (B), the sponsor 

3 of a drug shall submit an application to the 

4 Secretary at such time, in such manner, and 

5 containing such information as the Secretary 

6 may require. 

7 ‘‘(2) SUBSEQUENT YEARS.—The Secretary may 

8 prohibit direct-to-consumer advertising of a drug 

9 during the period beginning at the end of the 3-year 

10 period described in paragraph (1)(A) if the Sec11 retary determines that the drug has significant ad12 verse health effects based on post-approval studies, 

13 risk-benefit analyses, adverse event reports, the sci14 entific literature, any clinical or observational stud15 ies, or any other appropriate resource. 

16 ‘‘(b) REGULATIONS.—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 gov19 erning drug advertisements to the extent necessary to im20 plement this section. 

21 ‘‘(c) RULE OF CONSTRUCTION.—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 drugs under other provisions of law. 


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1 ‘‘(d) EFFECTIVE DATE.—This section applies only 

2 with respect to a drug for which an application submitted 

3 under section 505(b) is approved on or after the date that 

4 is 1 year before the date of the enactment of this section.’’. 

Æ 


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