[Congressional Record Volume 163, Number 188 (Thursday, November 16, 2017)]
[Senate]
[Page S7301]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself, Mr. King, Mr. Brown, Mr. Franken, Ms. 
        Hassan, and Ms. Harris):
  S. 2157. 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; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2157

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

     SECTION 1. SHORT TITLE.

         This Act may be cited as the ``Drug-Price Transparency in 
     Communications Act''.

     SEC. 2. FINDINGS.

         Congress finds as follows:
         (1) Direct-to-consumer advertising of prescription 
     pharmaceuticals is legal in only 2 developed countries, the 
     United States and New Zealand.
         (2) Direct-to-consumer advertising of prescription 
     pharmaceuticals is designed to cause patients to pressure 
     physicians to prescribe certain medications.
         (3) In 2015, pharmaceutical companies spent more than 
     $100,000,000 on advertising with respect to each of 16 brand-
     name drugs, primarily new and expensive drugs.
         (4) Prescription rates of medications advertised directly 
     to consumers have increased by 34.2 percent compared to a 5.1 
     percent increase in other pharmaceuticals.
         (5) Prescription pharmaceuticals cost more in the United 
     States than they do in any other country.
         (6) The American Medical Association has passed 
     resolutions calling for the ban of direct-to-consumer 
     advertising of prescription pharmaceuticals, and to require 
     price transparency in any direct-to-consumer advertising.
         (7) The amount of spending by pharmaceutical companies in 
     marketing to health care providers is more than 4 times the 
     spending for direct-to-consumer advertising.
         (8) Health care providers are more likely to prescribe a 
     certain drug if they have received payments or marketing 
     materials from the manufacturer of that drug.

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

         (a) In General.--Section 303(g)(1) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 333(g)(1)) is amended--
         (1) by striking ``(A)'' and inserting ``(i)'';
         (2) by striking ``(B)'' and inserting (ii);
         (3) by striking ``(1) With respect'' and inserting 
     ``(1)(A) With respect'';
         (4) by striking ``this paragraph'' each place it appears 
     and inserting ``this subparagraph'';
         (5) by striking ``No other civil monetary penalties in 
     this Act (including the civil penalty in section 303(f)(4))'' 
     and inserting ``No civil monetary penalties (including the 
     civil penalty in section 303(f)(4)), other than the penalties 
     under this subparagraph and subparagraph (B)''; and
         (6) by adding at the end the following:
         ``(B) With respect to a person who is a holder of an 
     approved application under section 505 for a drug subject to 
     section 503(b) or under section 351 of the Public Health 
     Service Act, any such person who disseminates or causes 
     another party to disseminate a direct-to-consumer 
     advertisement that does not include the wholesale acquisition 
     cost (as defined in section 1847A(c)(6)(B) of the Social 
     Security Act) for a 30-day supply of the drug shall be liable 
     to the United States for a civil penalty in an amount not to 
     exceed $1,000,000 for the first such violation in any 3-year 
     period, and not to exceed $5,000,000 for each subsequent 
     violation in any 3-year period. For purposes of this 
     subparagraph, all violations under this paragraph occurring 
     in a single day shall be considered one violation. With 
     respect to advertisements that appear in magazines or other 
     publications that are published less frequently than daily, 
     each issue date (whether weekly or monthly) shall be treated 
     as a single day for the purpose of calculating the number of 
     violations under this subparagraph.''.
         (b) Transfer of Funds.--For each fiscal year, there are 
     authorized to be appropriated, and are appropriated, out of 
     any funds not otherwise obligated, to the Director of the 
     National Institutes of Health for purposes of carrying out 
     medical research, an amount equal to the amount collected in 
     penalties during the previous fiscal year for violations of 
     section 303(g)(1)(B) of the Federal Food, Drug, and Cosmetic 
     Act.
         (c) Regulations.--The Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     shall promulgate regulations to carry out subparagraph (B) of 
     section 303(g)(1) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 333(g)(1)), as added by subsection (a). Such 
     regulations shall include provisions setting forth--
         (1) a reasonable amount of time a manufacturer has to 
     update any direct-to-consumer advertising of a drug in 
     accordance with such subparagraph (B) after a change to the 
     wholesale acquisition cost of the drug; and
         (2) the specific manner in which the wholesale 
     acquisition cost of a drug is required to be conspicuously 
     disclosed in such direct-to-consumer advertisements in order 
     to communicate such single price metric to the public, which 
     shall include visual and audio (as applicable) components of 
     the advertisement, and which may include a brief qualitative 
     explanation of reduced cost availability for certain 
     consumers, such as through insurance cost-sharing 
     arrangements or patient assistance programs.

     SEC. 4. DRUG MANUFACTURER DUTY TO DISCLOSE DRUG PRICES TO 
                   PRACTITIONERS.

         (a) Duty to Disclose.--Whenever a drug manufacturer, 
     including any representative of the manufacturer, 
     communicates with a health care practitioner about a drug 
     manufactured by the drug manufacturer, including through 
     promotional, educational, or marketing communications, 
     meetings or paid events, and the provision of goods, gifts, 
     and samples, the drug manufacturer shall disclose to the 
     practitioner the wholesale acquisition cost (as defined in 
     section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 
     1395w-3a(c)(6)(B))) for a 30-day supply of the drug, which 
     may include a brief qualitative explanation of reduced cost 
     availability for certain consumers that is consistent with 
     the regulations described in section 3(c)(2).
         (b) Enforcement by Federal Trade Commission.--
         (1) Unfair or deceptive acts or practices.--A violation 
     of subsection (a) by a person with respect to whom the 
     Commission is empowered under section 5(a)(2) of the Federal 
     Trade Commission Act (15 U.S.C. 45(a)(2)) shall be treated as 
     a violation of a rule defining an unfair or deceptive act or 
     practice prescribed under section 18(a)(1)(B) of the Federal 
     Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
         (2) Powers of federal trade commission.--
         (A) In general.--The Federal Trade Commission shall 
     enforce this section in the same manner, by the same means, 
     and with the same jurisdiction, powers, and duties as though 
     all applicable terms and provisions of the Federal Trade 
     Commission Act (15 U.S.C. 41 et seq.) were incorporated into 
     and made a part of this Act.
         (B) Privileges and immunities.--Any person who violates 
     this section shall be subject to the penalties and entitled 
     to the privileges and immunities provided in the Federal 
     Trade Commission Act (15 U.S.C. 41 et seq.).
         (c) Rulemaking.--The Federal Trade Commission shall 
     promulgate in accordance with section 553 of title 5, United 
     States Code, such rules as may be necessary to carry out this 
     section.
         (d) Savings Provision.--Nothing in this section shall be 
     construed to limit, impair, or supersede the operation of the 
     Federal Trade Commission Act or any other provision of 
     Federal law.
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