Prescription Drug Price Relief Act of 2025

Key Points

• The bill would compare U.S. brand-name drug prices to the median price in five other wealthy countries — Canada, the United Kingdom, Germany, France, and Japan. If the U.S. price is higher, the drug would be labeled "excessively priced."
• For drugs found to be excessively priced, the government would strip away patent exclusivity and issue open licenses so any company can manufacture and sell a cheaper generic or biosimilar version. Generic applications would get fast-tracked review within 8 months.
• Even when international price data isn't available, the Secretary can still declare a drug excessively priced by weighing factors like R&D costs, patient population size, therapeutic benefit, whether prices outpaced inflation, and the drug's cumulative global revenues.
• Drug companies would be required to file detailed annual reports covering their U.S. and international prices, R&D spending broken out by category, marketing costs, and global revenues. Failure to comply triggers daily fines of 0.5% to 1% of the drug's gross sales revenue.
• A public database would be created listing every drug reviewed, whether it was deemed excessively priced, how many generic licenses were granted, and any petitions filed. Anyone — patients, insurers, or advocacy groups — can petition the Secretary to review a specific drug's price.
• Companies that license a drug under this law must sell it below the excessive price threshold and pay a reasonable royalty to the original patent holder — capped at the average pharmaceutical royalty rate reported to the IRS, or an amount set by the Secretary.

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