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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1218 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 1218

 To require that the retail list price for certain prescription drugs 
 and biological products may not exceed the average retail list price 
       for the drug or biological product among certain nations.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 19, 2023

  Mr. Hawley introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
 To require that the retail list price for certain prescription drugs 
 and biological products may not exceed the average retail list price 
       for the drug or biological product among certain nations.

    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 ``Fair Prescription Drug Prices for 
Americans Act''.

SEC. 2. INTERNATIONAL REFERENCE PRICING FOR PRESCRIPTION DRUGS AND 
              BIOLOGICAL PRODUCTS.

    (a) Definitions.--In this section:
            (1) Biological product.--The term ``biological product'' 
        means a biological product licensed under subsection (a) or (k) 
        of section 351 of the Public Health Service Act (42 U.S.C. 
        262).
            (2) Drug.--The term ``drug'' means a drug approved under 
        subsection (c) or (j) of section 505 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Cap on Retail List Price of Prescription Drugs and Biological 
Products.--The retail list price in the United States for a drug or a 
biological product may not exceed the average retail list price for the 
drug or biological product among Canada, France, Germany, Italy, Japan, 
and the United Kingdom, as calculated under subsection (c).
    (c) Calculation of Average Retail List Price.--The Secretary shall 
calculate on an annual basis the average retail list price for each 
drug and biological product sold in Canada, France, Germany, Italy, 
Japan, and the United Kingdom, through a combination of data reported 
by manufacturers of drugs and biological products under subsection (e) 
and data obtained through review of publicly filed materials by 
manufacturers of drugs and biological products in such countries.
    (d) Civil Monetary Penalty.--
            (1) In general.--Any manufacturer that violates subsection 
        (b) with respect to a drug or biological product shall be 
        subject to a civil monetary penalty imposed by the Secretary in 
        amount equal to the product obtained by multiplying--
                    (A) the difference between--
                            (i) the list price for the drug or 
                        biological product sold in the United States; 
                        and
                            (ii) the average retail list price for the 
                        drug or biological product sold in Canada, 
                        France, Germany, Italy, Japan, and the United 
                        Kingdom, as calculated under subsection (c); 
                        and
                    (B) 10.
            (2) Requirement.--The amount of a civil monetary penalty 
        under paragraph (1) shall be calculated and charged for each 
        unit of drug or biological product sold.
    (e) Data Collection.--Each manufacturer of a drug or biological 
product shall submit to the Secretary on an annual basis--
            (1) the list price for the drug or biological product sold 
        in the United States; and
            (2) the list price for the drug or biological product sold 
        in each of Canada, France, Germany, Italy, Japan, and the 
        United Kingdom.
    (f) Guidance and Regulations.--The Secretary shall issue guidance 
and promulgate regulations to implement this section.
                                 <all>
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