S-1818 — Prescription Drug Price Relief Act of 2025

YourVoice.Now Summary

Your MoneyCorporate BenefitsTransparency & Accountability

Cancels a drug's U.S. monopoly when it costs more here than in five other rich countries, clearing the way for cheaper copies.

Your Money

Cheaper copies of pricey brand drugs — sold below the brand's price

If HHS rules a drug's price too high, any company may make and sell it. The copy has to be priced under the level HHS called too high.

Faster approval of cheaper versions — FDA must act in 8 months

Applications to sell a generic or near-copy of one of these drugs move to the front of the line. The FDA gets 8 months to decide.

Corporate Benefits

Drug makers' exclusive rights — any company may copy the drug

The ruling ends the sales protections the FDA grants, including those for rare-disease and children's drugs. It also opens the patent to anyone who wants to make the drug.

Drug makers' final say on price — HHS may call any price excessive

Even a drug priced below the foreign middle price can be ruled too costly. HHS would weigh development costs, global sales, and price hikes that beat inflation.

Drug makers' gain from price hikes — government can sue it back

Raising the price after HHS rules against a drug, but before copies arrive, is what triggers this. HHS could go to court for every dollar the increase brought in.

Drug makers' deals to block copies — banned outright

Two companies could not team up to keep a licensed copy off the market. Such deals would break the federal law against unfair competition.

Transparency & Accountability

Public database of drug price rulings — names drug and maker

The database would show every brand-name drug HHS reviewed and how it ruled. It would sit on the FDA website in plain, easy-to-find form.

Your right to challenge a price — answer within 90 days

Anyone could ask HHS to rule on a single drug's price. HHS would have to decide within 90 days or post why it would not.

Drug makers' spending reports — research and ads, due January 15

Each year, makers would hand HHS a breakdown for every brand-name drug. It would cover trial-by-trial research costs, ad budgets, and public money they received.

Penalty for hiding price data — up to 1% of sales daily

A missing or false report costs 0.5 to 1 percent of that drug's yearly sales for each late day. The fines would fund research grants at the National Institutes of Health.

More about this bill

Brand-name drugs that cost more in the United States than abroad could lose their sales monopoly. Other companies could then make and sell cheaper copies. Those copies would have to be priced below the level the government called too high. The comparison uses the middle price in Canada, the United Kingdom, Germany, France, and Japan. The Health and Human Services Secretary would check the price of every brand-name drug at least once a year. Anyone could ask for a review of a single drug. The Secretary would answer within 90 days or post the reason for refusing. Results would go in a public database that names each drug and its maker. The Food and Drug Administration would then have 8 months to act on applications to sell a copy. Drug makers would file a yearly report on each brand-name drug by January 15. It would cover U.S. and foreign prices, research costs, advertising spending, and government help received. A late or false report would draw a daily fine of 0.5 to 1 percent of that drug's yearly sales. Money from those fines would pay for research grants at the National Institutes of Health. Companies making a copy would still owe the patent holder a royalty set by the government.

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: Senate
Status: summarized
Action: Introduced in Senate
Action Date: 2025-05-20
Date Added: 2026-03-30
Source: Congress.gov →

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