Bill > HR3375

This bill aims to control prescription drug and biological product prices in the United States by establishing an international reference pricing mechanism. Specifically, the bill would prohibit the retail list price of a drug or biological product in the US from exceeding the average retail list price in six countries: Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary of Health and Human Services would be responsible for calculating these average prices annually using data reported by drug manufacturers and publicly available information. If a manufacturer sets a price higher than the international average, they would be subject to a civil monetary penalty calculated by multiplying the price difference by 10 for each unit sold. Drug manufacturers would be required to submit annual reports detailing their list prices in the US and the six referenced countries. The bill defines key terms such as "drug" and "biological product" according to existing FDA and Public Health Service Act regulations, and mandates that the Secretary develop guidance and regulations to implement these provisions. The overall goal is to make prescription drugs and biological products more affordable for Americans by linking their prices to international market rates.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/3375/all-info