This bill aims to control prescription drug costs in the United States by implementing an international reference pricing system for certain drugs and biological products. It stipulates that the retail list price for these products in the U.S. cannot surpass the average retail list price observed in a group of six specified developed nations, including Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary of Health and Human Services is tasked with annually calculating this average price, drawing data from both manufacturer reports and publicly available information in the designated countries. Manufacturers are required to submit their U.S. and international list prices to the Secretary each year to facilitate this calculation and ensure compliance. Should a manufacturer's U.S. retail list price exceed the calculated international average, they would be subject to a substantial civil monetary penalty . This penalty is determined by multiplying the difference between the U.S. price and the international average by ten, applied per unit of the drug or biological product sold, with the Secretary issuing guidance for implementation.
This bill aims to control prescription drug costs in the United States by implementing an international reference pricing system for certain drugs and biological products. It stipulates that the retail list price for these products in the U.S. cannot surpass the average retail list price observed in a group of six specified developed nations, including Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary of Health and Human Services is tasked with annually calculating this average price, drawing data from both manufacturer reports and publicly available information in the designated countries. Manufacturers are required to submit their U.S. and international list prices to the Secretary each year to facilitate this calculation and ensure compliance. Should a manufacturer's U.S. retail list price exceed the calculated international average, they would be subject to a substantial civil monetary penalty . This penalty is determined by multiplying the difference between the U.S. price and the international average by ten, applied per unit of the drug or biological product sold, with the Secretary issuing guidance for implementation.