Responsibility in Drug Advertising Act of 2019

I 116TH CONGRESS 1ST SESSION H. R. 4106 To amend the Federal Food, Drug, and Cosmetic Act to restrict direct- to-consumer drug advertising. IN THE HOUSE OF REPRESENTATIVES JULY 30, 2019 Ms. DELAURO (for herself, Mr. KHANNA, and Mr. GRIJALVA) 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- 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 2019’’. 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 VerDate Sep 11 2014 02:13 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4106.IH H4106 kjohnson on DSK79L0C42 with BILLS 2 •HR 4106 IH ‘‘(fff) The conduct of direct-to-consumer advertising 1 of a drug in violation of section 506J.’’; and 2 (2) in chapter V, by inserting after section 506I 3 (21 U.S.C. 356f) the following: 4 ‘‘SEC. 506J. DIRECT-TO-CONSUMER DRUG ADVERTISING. 5 ‘‘(a) PROHIBITIONS.— 6 ‘‘(1) FIRST THREE YEARS.— 7 ‘‘(A) IN GENERAL.—Subject to subpara- 8 graph (B), no person shall conduct direct-to- 9 consumer advertising of a drug for which an 10 application is submitted under section 505(b) 11 before the end of the 3-year period beginning 12 on the date of the approval of such application. 13 ‘‘(B) WAIVER.—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 VerDate Sep 11 2014 02:13 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4106.IH H4106 kjohnson on DSK79L0C42 with BILLS 3 •HR 4106 IH ‘‘(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) SUBSEQUENT YEARS.—The Secretary may 7 prohibit direct-to-consumer advertising of a drug 8 during the period beginning at the end of the 3-year 9 period described in paragraph (1)(A) if the Sec- 10 retary determines that the drug has significant ad- 11 verse health effects based on post-approval studies, 12 risk-benefit analyses, adverse event reports, the sci- 13 entific literature, any clinical or observational stud- 14 ies, or any other appropriate resource. 15 ‘‘(b) REGULATIONS.—Not later than 1 year after the 16 date of the enactment of this section, the Secretary shall 17 revise the regulations promulgated under this Act gov- 18 erning drug advertisements to the extent necessary to im- 19 plement this section. 20 ‘‘(c) RULE OF CONSTRUCTION.—This section shall 21 not be construed to diminish the authority of the Secretary 22 to prohibit or regulate direct-to-consumer advertising of 23 drugs under other provisions of law. 24 VerDate Sep 11 2014 02:13 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4106.IH H4106 kjohnson on DSK79L0C42 with BILLS 4 •HR 4106 IH ‘‘(d) EFFECTIVE DATE.—This section applies only 1 with respect to a drug for which an application submitted 2 under section 505(b) is approved on or after the date that 3 is 1 year before the date of the enactment of this section.’’. 4 Æ VerDate Sep 11 2014 02:13 Aug 15, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H4106.IH H4106 kjohnson on DSK79L0C42 with BILLS