119 S1587 IS: Fair Prescription Drug Prices for Americans Act U.S. Senate 2025-05-05 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II119th CONGRESS1st SessionS. 1587IN THE SENATE OF THE UNITED STATESMay 5, 2025Mr. Hawley (for himself and Mr. Welch) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo 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.

1.

Short title

This Act may be cited as the Fair Prescription Drug Prices for Americans Act.

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.