This legislation aims to lower brand‑name prescription drug prices. It tells the health department to check drug prices every year and flag any drug that costs more in the U.S. than the middle price in Canada, the U.K., Germany, France, and Japan. If a drug is “excessively priced,” the government can open it up to competition by ending special exclusivity rights and letting other companies make and sell it, with a fair royalty paid to the patent holder. Generics and biosimilars tied to these decisions get faster review (goal: action within 8 months). Anyone can ask the department to review a drug’s price, and the agency must explain its decision. A public database will list which drugs are overpriced and what actions were taken .

Drug makers must report detailed pricing, sales, and R&D and marketing spending each year. Missing or false reports can lead to daily fines, with the money used to support NIH research. Companies also cannot work together in ways that block these new licenses or keep prices high. Licensed competitors must sell below the “excessive” price and pay reasonable royalties set to keep prices affordable. The government will publish clear annual summaries so the public can see results and trends .

• Who is affected: Patients (lower prices), brand‑name drug makers (more reporting and risk of losing exclusivity if prices are too high), generic and biosimilar makers (new paths to enter the market) .
• What changes: Annual price checks using other countries’ prices; ability to end exclusivity for overpriced drugs; open licenses with fair royalties; faster review for new competitors; public price database; annual reports to Congress; penalties for non‑reporting; ban on anti‑competitive deals .
• When: Process starts within 30 days of enactment; reviews happen at least yearly; agency aims to act on competitor applications within 8 months; manufacturer reports are due each year starting the January after enactment .