119-hr3375

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3375 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3375

 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 HOUSE OF REPRESENTATIVES

 May 13, 2025

 Mr. Van Drew introduced the following bill; which was referred to the 
 Committee on Energy and Commerce

_______________________________________________________________________

 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>