II 

115TH CONGRESS 

1ST SESSION S. 2157 

To require drug manufacturers to disclose the prices of prescription drugs 

in any direct-to-consumer advertising and marketing to practitioners of 

a drug. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 16, 2017 

Mr. DURBIN (for himself, Mr. KING, Mr. BROWN, Mr. FRANKEN, Ms. HASSAN, and Ms. HARRIS) introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To require drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and 

marketing to practitioners of a drug. 

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 ‘‘Drug-Price Trans5 parency in Communications Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 


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1 (1) Direct-to-consumer advertising of prescrip2 tion pharmaceuticals is legal in only 2 developed 

3 countries, the United States and New Zealand. 

4 (2) Direct-to-consumer advertising of prescrip5 tion pharmaceuticals is designed to cause patients to 

6 pressure physicians to prescribe certain medications. 

7 (3) In 2015, pharmaceutical companies spent 

8 more than $100,000,000 on advertising with respect 

9 to each of 16 brand-name drugs, primarily new and 

10 expensive drugs. 

11 (4) Prescription rates of medications advertised 

12 directly to consumers have increased by 34.2 percent 

13 compared to a 5.1 percent increase in other pharma14 ceuticals. 

15 (5) Prescription pharmaceuticals cost more in 

16 the United States than they do in any other country. 

17 (6) The American Medical Association has 

18 passed resolutions calling for the ban of direct-to19 consumer advertising of prescription pharma20 ceuticals, and to require price transparency in any 

21 direct-to-consumer advertising. 

22 (7) The amount of spending by pharmaceutical 

23 companies in marketing to health care providers is 

24 more than 4 times the spending for direct-to-con25 sumer advertising. 


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1 (8) Health care providers are more likely to 

2 prescribe a certain drug if they have received pay3 ments or marketing materials from the manufac4 turer of that drug. 

5 SEC. 3. PRICE DISCLOSURE REQUIREMENT FOR DIRECT6 TO-CONSUMER DRUG ADVERTISEMENTS. 

7 (a) IN GENERAL.—Section 303(g)(1) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)) is 

9 amended— 

10 (1) by striking ‘‘(A)’’ and inserting ‘‘(i)’’; 

11 (2) by striking ‘‘(B)’’ and inserting (ii); 

12 (3) by striking ‘‘(1) With respect’’ and inserting 

13 ‘‘(1)(A) With respect’’; 

14 (4) by striking ‘‘this paragraph’’ each place it 

15 appears and inserting ‘‘this subparagraph’’; 

16 (5) by striking ‘‘No other civil monetary pen17 alties in this Act (including the civil penalty in sec18 tion 303(f)(4))’’ and inserting ‘‘No civil monetary 

19 penalties (including the civil penalty in section 

20 303(f)(4)), other than the penalties under this sub21 paragraph and subparagraph (B)’’; and 

22 (6) by adding at the end the following: 

23 ‘‘(B) With respect to a person who is a holder of an 

24 approved application under section 505 for a drug subject 

25 to section 503(b) or under section 351 of the Public 


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1 Health Service Act, any such person who disseminates or 

2 causes another party to disseminate a direct-to-consumer 

3 advertisement that does not include the wholesale acquisi4 tion cost (as defined in section 1847A(c)(6)(B) of the So5 cial Security Act) for a 30-day supply of the drug shall 

6 be liable to the United States for a civil penalty in an 

7 amount not to exceed $1,000,000 for the first such viola8 tion in any 3-year period, and not to exceed $5,000,000 

9 for each subsequent violation in any 3-year period. For 

10 purposes of this subparagraph, all violations under this 

11 paragraph occurring in a single day shall be considered 

12 one violation. With respect to advertisements that appear 

13 in magazines or other publications that are published less 

14 frequently than daily, each issue date (whether weekly or 

15 monthly) shall be treated as a single day for the purpose 

16 of calculating the number of violations under this subpara17 graph.’’. 

18 (b) TRANSFER OF FUNDS.—For each fiscal year, 

19 there are authorized to be appropriated, and are appro20 priated, out of any funds not otherwise obligated, to the 

21 Director of the National Institutes of Health for purposes 

22 of carrying out medical research, an amount equal to the 

23 amount collected in penalties during the previous fiscal 

24 year for violations of section 303(g)(1)(B) of the Federal 

25 Food, Drug, and Cosmetic Act. 


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1 (c) REGULATIONS.—The Secretary of Health and 

2 Human Services, acting through the Commissioner of 

3 Food and Drugs, shall promulgate regulations to carry out 

4 subparagraph (B) of section 303(g)(1) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)), as 

6 added by subsection (a). Such regulations shall include 

7 provisions setting forth— 

8 (1) a reasonable amount of time a manufac9 turer has to update any direct-to-consumer adver10 tising of a drug in accordance with such subpara11 graph (B) after a change to the wholesale acquisi12 tion cost of the drug; and 

13 (2) the specific manner in which the wholesale 

14 acquisition cost of a drug is required to be conspicu15 ously disclosed in such direct-to-consumer advertise16 ments in order to communicate such single price 

17 metric to the public, which shall include visual and 

18 audio (as applicable) components of the advertise19 ment, and which may include a brief qualitative ex20 planation of reduced cost availability for certain con21 sumers, such as through insurance cost-sharing ar22 rangements or patient assistance programs. 


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1 SEC. 4. DRUG MANUFACTURER DUTY TO DISCLOSE DRUG 

2 PRICES TO PRACTITIONERS. 

3 (a) DUTY TO DISCLOSE.—Whenever a drug manu4 facturer, including any representative of the manufac5 turer, communicates with a health care practitioner about 

6 a drug manufactured by the drug manufacturer, including 

7 through promotional, educational, or marketing commu8 nications, meetings or paid events, and the provision of 

9 goods, gifts, and samples, the drug manufacturer shall dis10 close to the practitioner the wholesale acquisition cost (as 

11 defined in section 1847A(c)(6)(B) of the Social Security 

12 Act (42 U.S.C. 1395w–3a(c)(6)(B))) for a 30-day supply 

13 of the drug, which may include a brief qualitative expla14 nation of reduced cost availability for certain consumers 

15 that is consistent with the regulations described in section 

16 3(c)(2). 

17 (b) ENFORCEMENT BY FEDERAL TRADE COMMIS18 SION.— 

19 (1) UNFAIR OR DECEPTIVE ACTS OR PRAC20 TICES.—A violation of subsection (a) by a person 

21 with respect to whom the Commission is empowered 

22 under section 5(a)(2) of the Federal Trade Commis23 sion Act (15 U.S.C. 45(a)(2)) shall be treated as a 

24 violation of a rule defining an unfair or deceptive act 

25 or practice prescribed under section 18(a)(1)(B) of 


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1 the Federal Trade Commission Act (15 U.S.C. 

2 57a(a)(1)(B)). 

3 (2) POWERS OF FEDERAL TRADE COMMIS4 SION.— 

5 (A) IN GENERAL.—The Federal Trade 

6 Commission shall enforce this section in the 

7 same manner, by the same means, and with the 

8 same jurisdiction, powers, and duties as though 

9 all applicable terms and provisions of the Fed10 eral Trade Commission Act (15 U.S.C. 41 et 

11 seq.) were incorporated into and made a part of 

12 this Act. 

13 (B) PRIVILEGES AND IMMUNITIES.—Any 

14 person who violates this section shall be subject 

15 to the penalties and entitled to the privileges 

16 and immunities provided in the Federal Trade 

17 Commission Act (15 U.S.C. 41 et seq.). 

18 (c) RULEMAKING.—The Federal Trade Commission 

19 shall promulgate in accordance with section 553 of title 

20 5, United States Code, such rules as may be necessary 

21 to carry out this section. 

22 (d) SAVINGS PROVISION.—Nothing in this section 

23 shall be construed to limit, impair, or supersede the operVerDate Sep 11 2014 19:31 Nov 24, 2017 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2157.IS S2157

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1 ation of the Federal Trade Commission Act or any other 

2 provision of Federal law. 

Æ 


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