This legislation aims to control prescription drug costs in the United States by implementing an international reference pricing system. It mandates that the retail list price for a drug or biological product in the U.S. cannot exceed the average retail list price of that same product across six specified nations: Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary of Health and Human Services is tasked with annually calculating this average price, utilizing data reported by manufacturers and publicly available information. Manufacturers are required to submit their U.S. and international list prices, and any violation of the price cap will result in a civil monetary penalty . This penalty is calculated as ten times the difference between the U.S. list price and the international average, applied per unit sold, ensuring enforcement of the new pricing standard.