Creates a cap on U.S. retail list prices for prescription drugs and biological products by tying the maximum U.S. retail list price to the average retail list price in Canada, France, Germany, Italy, Japan, and the United Kingdom. The Department of Health and Human Services must collect annual price data, calculate the allowed U.S. cap, publish guidance and regulations, and enforce the cap with civil penalties for manufacturers that exceed it.

The proposal requires yearly reporting and calculations, gives HHS authority to implement the rulemaking, and establishes penalties for noncompliance. It changes how manufacturers set U.S. list prices and creates new administrative duties for both industry and the federal government, with likely effects on consumers, payers, manufacturers, and drug availability dynamics.