Fair Prescription Drug Prices for Americans Act

II 118TH CONGRESS 1ST SESSION S. 1218 To require that the retail list price for certain prescription drugs and biologi- cal 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Fair Prescription Drug 4 Prices for Americans Act’’. 5 VerDate Sep 11 2014 22:45 Apr 21, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1218.IS S1218 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1218 IS SEC. 2. INTERNATIONAL REFERENCE PRICING FOR PRE- 1 SCRIPTION DRUGS AND BIOLOGICAL PROD- 2 UCTS. 3 (a) DEFINITIONS.—In this section: 4 (1) BIOLOGICAL PRODUCT.—The term ‘‘biologi- 5 cal product’’ means a biological product licensed 6 under subsection (a) or (k) of section 351 of the 7 Public Health Service Act (42 U.S.C. 262). 8 (2) DRUG.—The term ‘‘drug’’ means a drug ap- 9 proved under subsection (c) or (j) of section 505 of 10 the Federal Food, Drug, and Cosmetic Act (21 11 U.S.C. 355). 12 (3) SECRETARY.—The term ‘‘Secretary’’ means 13 the Secretary of Health and Human Services. 14 (b) CAP ON RETAIL LIST PRICE OF PRESCRIPTION 15 DRUGS AND BIOLOGICAL PRODUCTS.—The retail list 16 price in the United States for a drug or a biological prod- 17 uct may not exceed the average retail list price for the 18 drug or biological product among Canada, France, Ger- 19 many, Italy, Japan, and the United Kingdom, as cal- 20 culated under subsection (c). 21 (c) CALCULATION OF AVERAGE RETAIL LIST 22 PRICE.—The Secretary shall calculate on an annual basis 23 the average retail list price for each drug and biological 24 product sold in Canada, France, Germany, Italy, Japan, 25 and the United Kingdom, through a combination of data 26 VerDate Sep 11 2014 22:45 Apr 21, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1218.IS S1218 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1218 IS reported by manufacturers of drugs and biological prod- 1 ucts under subsection (e) and data obtained through re- 2 view of publicly filed materials by manufacturers of drugs 3 and biological products in such countries. 4 (d) CIVIL MONETARY PENALTY.— 5 (1) IN GENERAL.—Any manufacturer that vio- 6 lates subsection (b) with respect to a drug or biologi- 7 cal product shall be subject to a civil monetary pen- 8 alty imposed by the Secretary in amount equal to 9 the product obtained by multiplying— 10 (A) the difference between— 11 (i) the list price for the drug or bio- 12 logical product sold in the United States; 13 and 14 (ii) the average retail list price for the 15 drug or biological product sold in Canada, 16 France, Germany, Italy, Japan, and the 17 United Kingdom, as calculated under sub- 18 section (c); and 19 (B) 10. 20 (2) REQUIREMENT.—The amount of a civil 21 monetary penalty under paragraph (1) shall be cal- 22 culated and charged for each unit of drug or biologi- 23 cal product sold. 24 VerDate Sep 11 2014 22:45 Apr 21, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1218.IS S1218 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1218 IS (e) DATA COLLECTION.—Each manufacturer of a 1 drug or biological product shall submit to the Secretary 2 on an annual basis— 3 (1) the list price for the drug or biological prod- 4 uct sold in the United States; and 5 (2) the list price for the drug or biological prod- 6 uct sold in each of Canada, France, Germany, Italy, 7 Japan, and the United Kingdom. 8 (f) GUIDANCE AND REGULATIONS.—The Secretary 9 shall issue guidance and promulgate regulations to imple- 10 ment this section. 11 Æ VerDate Sep 11 2014 22:45 Apr 21, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S1218.IS S1218 kjohnson on DSK79L0C42PROD with BILLS