H.R. 3375 — Fair Prescription Drug Prices for Americans Act

This section establishes a cap prohibiting the U.S. retail list price of a drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—i.e., new drugs and generics—or a biological product licensed under subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262)—i.e., biologics and biosimilars—from exceeding the average retail list price for that product in Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary of Health and Human Services (HHS) calculates the average annually using manufacturer-reported list prices and publicly filed data. Manufacturers must submit U.S. and foreign list prices to HHS annually. HHS imposes a civil monetary penalty on violating manufacturers equal to 10 times the per-unit excess of the U.S. list price over the foreign average. HHS must issue guidance and promulgate regulations to implement these requirements.