Fair Prescription Drug Prices for Americans Act

Bill: 118-s-1218
Sponsor: full_name: Sen. Hawley, Josh [R-MO]
Introduced: 2023-04-19
Policy area: Health
Latest action: action_date: 2023-04-19
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2023-04-19
action_desc: Introduced in Senate
text: <p><b>Fair Prescription Drug Prices for Americans Act</b></p> <p>This bill caps the price of drugs and biologics at the average price among certain countries.</p> <p>Specifically, the retail list price of a drug or biologic in the United States may not exceed the average retail list price among Canada, France, Germany, Italy, Japan, and the United Kingdom. The Department of Health and Human Services (HHS) must calculate the average price in these countries based on data that is submitted by manufacturers directly to HHS and on publicly filed materials from manufacturers. </p> <p>Manufacturers who violate the bill's price cap are subject to civil penalties.</p>

tv_txt: II 118th CONGRESS 1st Session S. 1218 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. 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.