II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Fair Prescription Drug 

5 Prices for Americans Act’’. 


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1 SEC. 2. INTERNATIONAL REFERENCE PRICING FOR PRE2 SCRIPTION DRUGS AND BIOLOGICAL PROD3 UCTS. 

4 (a) DEFINITIONS.—In this section: 

5 (1) BIOLOGICAL PRODUCT.—The term ‘‘biologi6 cal product’’ means a biological product licensed 

7 under subsection (a) or (k) of section 351 of the 

8 Public Health Service Act (42 U.S.C. 262). 

9 (2) DRUG.—The term ‘‘drug’’ means a drug ap10 proved under subsection (c) or (j) of section 505 of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 355). 

13 (3) SECRETARY.—The term ‘‘Secretary’’ means 

14 the Secretary of Health and Human Services. 

15 (b) CAP ON RETAIL LIST PRICE OF PRESCRIPTION

16 DRUGS AND BIOLOGICAL PRODUCTS.—The retail list 

17 price in the United States for a drug or a biological prod18 uct may not exceed the average retail list price for the 

19 drug or biological product among Canada, France, Ger20 many, Italy, Japan, and the United Kingdom, as cal21 culated under subsection (c). 

22 (c) CALCULATION OF AVERAGE RETAIL LIST

23 PRICE.—The Secretary shall calculate on an annual basis 

24 the average retail list price for each drug and biological 

25 product sold in Canada, France, Germany, Italy, Japan, 

26 and the United Kingdom, through a combination of data 


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1 reported by manufacturers of drugs and biological prod2 ucts under subsection (e) and data obtained through re3 view of publicly filed materials by manufacturers of drugs 

4 and biological products in such countries. 

5 (d) CIVIL MONETARY PENALTY.— 

6 (1) IN GENERAL.—Any manufacturer that vio7 lates subsection (b) with respect to a drug or biologi8 cal product shall be subject to a civil monetary pen9 alty imposed by the Secretary in amount equal to 

10 the product obtained by multiplying— 

11 (A) the difference between— 

12 (i) the list price for the drug or bio13 logical product sold in the United States; 

14 and 

15 (ii) the average retail list price for the 

16 drug or biological product sold in Canada, 

17 France, Germany, Italy, Japan, and the 

18 United Kingdom, as calculated under sub19 section (c); and 

20 (B) 10. 

21 (2) REQUIREMENT.—The amount of a civil 

22 monetary penalty under paragraph (1) shall be cal23 culated and charged for each unit of drug or biologi24 cal product sold. 


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1 (e) DATA COLLECTION.—Each manufacturer of a 

2 drug or biological product shall submit to the Secretary 

3 on an annual basis— 

4 (1) the list price for the drug or biological prod5 uct sold in the United States; and 

6 (2) the list price for the drug or biological prod7 uct sold in each of Canada, France, Germany, Italy, 

8 Japan, and the United Kingdom. 

9 (f) GUIDANCE AND REGULATIONS.—The Secretary 

10 shall issue guidance and promulgate regulations to imple11 ment this section. 

Æ 


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