HR-3546 — Prescription Drug Price Relief Act of 2025

YourVoice.Now Summary

Your MoneyCorporate BenefitsTransparency & Accountability

Cheaper generic copies could reach the shelf when a brand-name drug costs more here than in five other rich countries.

Your Money

Brand-name drug prices — generics allowed when U.S. price tops five-country median

Officials would compare the drug's price here to the middle price in Canada, the United Kingdom, Germany, France, and Japan. If ours is higher, the drug loses its monopoly. Other firms could then make it.

Wait for cheaper generic versions — FDA must decide within 8 months

Say a drug loses its monopoly. The FDA would then have eight months to act on requests to sell a generic. The agency must move those requests to the front of the line.

Corporate Benefits

Drug makers' monopoly rights — canceled once a price is ruled excessive

Officials would have to end the drug's government-granted monopoly the same day they rule its price too high. Firms making copies would still pay the patent holder a royalty. That royalty is capped so the drug stays affordable.

Missing price reports — daily fines up to 1% of drug sales

A company that files late or reports false numbers would owe 0.5% to 1% of that drug's sales last year for every day it is late. The money would fund research grants at the National Institutes of Health.

Price hikes after a ruling — government can sue for the added revenue

Say a maker raises the price after the ruling but before a generic is being made. The government could then sue in federal court. Damages would be at least all the money made from the increase.

Deals that block generic makers — banned under federal antitrust law

Drug makers could not team up in ways that get in the way of the open licenses this bill creates. The test is the Federal Trade Commission Act's ban on unfair competition.

Transparency & Accountability

Public database of drug prices — lists which drugs were ruled excessive

The FDA would post a list of every brand-name drug and its maker. The list would show whether each price was ruled too high. Rulings would go up within 30 days of the pricing data arriving.

Drug company spending disclosed — yearly reports on research, ads, and revenue

Each January 15, makers would report each drug's prices here and abroad. They would report global revenue and research costs, broken out by trial. They would also report ad spending and any public money they got.

Anyone can challenge a drug's price — answer required within 90 days

Any person could ask for a price review. Officials would have 90 days to rule or to publicly explain why they said no, and every request and reason would be posted online.

More about this bill

If you take a brand-name drug that costs more here than in other wealthy countries, its price could fall. Health officials would compare the American price to the middle price in Canada, the United Kingdom, Germany, France, and Japan. A higher price here would end that drug's monopoly. Officials could also rule a price too high for other reasons, such as heavy federal research funding. Any company could then get a license to make a copy. Those copies would have to sell for less than the price ruled too high. Officials would set up the review within 30 days of the law passing and repeat it every year. Drug makers would have to report their American and foreign prices each January 15. They would also report what they spend on research and on ads. Late or false reports could cost them up to 1 percent of that drug's yearly sales for each day of delay. The Food and Drug Administration (FDA) would get 8 months to rule on generic applications. Anyone could ask the government to review a drug's price. Officials would have 90 days to answer or to explain why they will not. A public website would list each drug, its maker, and whether the price was ruled too high. The petitions and the reasons behind each ruling would be posted there too.

Congressional Summary

This bill requires the Department of Health and Human Services (HHS) to review brand-name drugs annually for excessive pricing and, if a drug is found to be priced excessively, to void any exclusivity granted to its sponsor.Specifically, HHS must review all brand-name drug prices at least annually and upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.An entity accepting an open, nonexclusive license under these provisions must pay a reasonable royalty to the holder of the relevant patent or approved new drug application, and must price the generic drug or biosimilar below the excessive rate.Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of these countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including development cost, revenue, and the size of the affected patient population.The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.

Details

Congress: 119th
Chamber: House
Status: summarized
Action: Introduced in House
Action Date: 2025-05-21
Date Added: 2026-03-30
Source: Congress.gov →

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