This bill aims to lower prescription drug costs by checking brand‑name drug prices each year and opening the door to competition when prices are too high. The Secretary of Health and Human Services must set up a yearly review within 30 days. A drug is deemed overpriced if its U.S. price is higher than the median price in Canada, the United Kingdom, Germany, France, and Japan. If that data isn’t available, the Secretary can judge prices using other factors like the drug’s value to patients, research costs, government support, total revenues, and whether price hikes beat inflation.

If a drug is found overpriced, the government ends its exclusive protections and issues open licenses so other companies can make and sell lower‑cost generics or biosimilars, with faster FDA review (action within 8 months). Licensed makers must pay a reasonable royalty and sell the drug below the excessive price level. If the brand raises its price after the ruling and before a competitor starts making the drug, the Secretary can sue to recover at least the extra revenue from that increase .

The bill also creates a public database of these price decisions, requires drug makers to report detailed pricing, sales, R&D, and marketing data each year, and bans anticompetitive behavior that would block these licenses. Companies that fail to report face daily fines tied to 0.5%–1% of the drug’s prior‑year sales, and the money goes to NIH research grants .

• Who is affected

  • Patients who need prescription drugs
  • Brand‑name drug makers, and companies that make generics or biosimilars

• What changes

  • Yearly price checks for all brand‑name drugs, using other countries’ prices and clear factors to judge fairness
  • Open licenses and faster review to bring lower‑cost versions to market sooner, with royalties to the original company and required lower prices
  • Public transparency through a database; strong reporting rules; and a ban on anticompetitive behavior that could block competition

• When

  • Within 30 days after the law takes effect: set up the review process
  • FDA action within 8 months on applications tied to an open license
  • By January 15 after enactment and every year after: manufacturers submit required reports
  • Certain price decisions must be posted to the public database within 30 days of receiving pricing data