S. 1818: Prescription Drug Price Relief Act of 2025

S. 1818, the Prescription Drug Price Relief Act of 2025, would create a new federal process for flagging overpriced brand-name drugs and breaking the market power behind them. The Secretary of Health and Human Services would have to set up that review process not later than 30 days after enactment, and review all brand name drugs at least once per calendar year. A drug would count as “excessive” when its domestic average manufacturing price is higher than the median price in 5 reference countries — Canada, the United Kingdom, Germany, France, and Japan — as long as pricing data exists for at least 3 of those 5 countries.

The bill does not stop at naming and shaming. Once a drug is labeled excessive, the Secretary must waive or void all government-granted exclusivities and grant open, non-exclusive licenses. That means other companies could use patents or regulatory test data to produce, manufacture, import, export, distribute, or sell the drug. The FDA would then have to prioritize related generic or biosimilar applications and act within 8 months. The Secretary could also sue a manufacturer that raises prices after the excessive-price determination and before a generic or biosimilar reaches the market, with damages set at not less than the total revenue derived from the price increase.

The bill also builds a paper trail to support those decisions. Drug manufacturers would have to file annual reports by January 15 with detailed data, including quarterly U.S. and foreign average manufacturer prices and wholesale acquisition costs, cumulative global revenues, annual net sales, itemized research and development spending, marketing and advertising expenditures, human clinical trial investments including public subsidies or tax credits, and estimated patient population. If a company files late, it could be fined 0.5% to 1% of the previous year’s gross sales of the drug, multiplied by the number of days late. Those penalties would be directed to National Institutes of Health competitive research grants.

The measure also gives the public and Congress more visibility. Anyone could petition the Secretary to review a drug’s price, though not more than once per calendar year per drug, and the Secretary would have to act within 90 days. Petitions, supporting documents, and rationales would have to be made public. The FDA would also have to maintain a public database showing each drug’s name, manufacturer, excessive-price status, petition counts, license counts, and generic or biosimilar application and approval counts, with an annual report to Congress due not later than 60 days after the first review is completed and every year after that.