Text: H.R.6576 — 115th Congress (2017-2018)All Information (Except Text)

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Introduced in House (07/26/2018)

 
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6576 Introduced in House (IH)]

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115th CONGRESS
  2d Session
                                H. R. 6576

 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 HOUSE OF REPRESENTATIVES

                             July 26, 2018

Ms. Schakowsky introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 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.

    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.
                                 <all>

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