S. 1818 — Prescription Drug Price Relief Act of 2025

This section directs the Secretary of Health and Human Services to establish, not later than 30 days after enactment, a process to review all brand name drugs not less frequently than once per calendar year to determine whether each drug's domestic average manufacturer price is excessive. The section specifies that a brand name drug has an excessive price if that price exceeds the median price in at least three of five reference countries (Canada, the United Kingdom, Germany, France, and Japan), with consideration of additional factors; or, if not determined excessive under that test (including due to insufficient data), if the price is higher than reasonable based on factors such as the size of the affected patient population, the drug's value and impact on access, federal subsidies and investments, development costs, health outcome improvements over prior therapies, cumulative global revenues, and domestic price increases exceeding the consumer price index for all urban consumers. The section further allows any person to petition the Secretary, pursuant to the Administrative Procedure Act, for an excessive price determination under the multifactor test, requiring a response within 90 days (either a determination or a public declination with reasons), not more frequently than once per calendar year per drug, and public posting of all petitions, documentation, and decisions on a database under section 5.

This section requires the Secretary of Health and Human Services, for any brand name drug determined to have an excessive price under section 2, to (1) waive or void all government-granted exclusivities effective on the date of such determination; and (2) grant open, non-exclusive licenses to any person to manufacture, use, offer to sell or sell, or import the drug into the United States and to rely on its regulatory test data in accordance with section 4. The section further directs the Secretary to prioritize and complete review of any generic drug or biosimilar biological product application referencing such a licensed drug within eight months and authorizes the Secretary to bring civil actions against the manufacturer for any price increases during the period from the excessive price determination until licensed manufacturing begins, seeking damages of at least the total revenue from such increases (with courts empowered to grant injunctive relief and compensatory damages).

This section requires an entity accepting an open, non-exclusive license under section 3(a)(2)—issued after termination of government-granted exclusivity for a drug priced excessively—to pay a reasonable royalty to the relevant patent holder or to the holder of an FDA new drug application (NDA, 21 U.S.C. 355(c)) or biologics license application (BLA, 42 U.S.C. 262(a)). The royalty rate is either (1) a percentage of sales no higher than the average royalty rate estimated from Internal Revenue Service data on pharmaceutical manufacturers' federal income tax returns; or (2) an amount determined by the Secretary of Health and Human Services considering factors such as the drug's value to patients, affected patient population size, risk-adjusted federal subsidies and investments, health outcome improvements over prior therapies, originator's recovery of risk-adjusted investments, and other relevant information. The section further requires that the royalty rate support affordable drug prices for all purchasers (Thus, no royalty may result in sales at an excessive price per section 2); apportions royalties among multiple patent holders or investors by agreement or Secretary determination; and mandates sales below the excessive price threshold under section 2(b).

This section directs the Secretary to establish and maintain a public database of brand name drugs and excessive price determinations under section 2, including for each such drug in the applicable calendar year (1) the drug name and manufacturer; (2) whether the drug was determined to have an excessive price under section 2(b); (3) the number of petitions received under section 2(c), with related information; (4) the number of open, non-exclusive licenses granted under section 3(a)(2) for generic or biosimilar versions; and (5) the number of applications under subsection (b)(2) or (j) of section 505 of the FD&C Act (21 U.S.C. 355) or section 351(k) of the PHS Act (42 U.S.C. 262(k)) submitted and approved pursuant to such licenses. It further requires the Secretary to publish section 2(b)(1) determinations on the database within 30 days of receiving pricing information under section 6; to submit annual reports to Congress beginning 60 days after the first section 2 review is complete—summarizing drugs reviewed and determined excessively priced (with names and manufacturers), licensing and application data, petition counts, non-reporting manufacturers under section 6, and other metrics; and to make the database and reports publicly available on the FDA website in an accessible format.

This section requires each manufacturer to submit an annual report to the Secretary for each brand name drug covering the previous calendar year, including (1) average manufacturer prices and wholesale acquisition costs in the United States and reference countries, annually and quarterly; (2) cumulative global revenues and annual net sales revenues in the United States and reference countries, annually and quarterly; (3) total domestic and foreign research and development expenditures itemized by category (e.g., basic research, clinical trials, supplemental applications under 21 U.S.C. 355, and postmarket requirements); (4) marketing and advertising expenditures; (5) investments in human clinical trials by source; (6) estimated affected patient population size; and (7) additional pricing or other information as specified. Reports are due by January 15 of the following year. This section imposes civil monetary penalties on manufacturers for untimely or false submissions, equal to 0.5% to 1% of the drug's prior-year gross sales revenues multiplied by days late, with collected funds supporting National Institutes of Health competitive research grants.

This section prohibits a manufacturer from engaging in anticompetitive behavior violating section 5(a) of the Federal Trade Commission Act (15 U.S.C. 45(a))—i.e., unfair methods of competition in or affecting commerce, or unfair or deceptive acts or practices in or affecting commerce—with another manufacturer if such behavior may interfere with the issuance or implementation of open, non-exclusive licenses under this Act or otherwise run contrary to the public interest in the availability of affordable prescription drugs.

This section defines terms for purposes of the Act, including (1) average manufacturer price, generally as defined in SSA §1927(k)(1) or, if inapplicable, wholesale acquisition cost, with prices in reference countries determined based on the price there; (2) biosimilar biological product, as licensed under PHSA §351(k); (3) brand name drug, as approved under FDCA §505(b)(1) or licensed under PHSA §351(a), subject to prescription requirements under FDCA §503(b)(1), and claimed in a patent; (4) generic drug, as approved under FDCA §505(b)(2) or (j); (5) government-granted exclusivity, as certain statutory prohibitions on competing drug applications (e.g., pediatric exclusivity under FDCA §505A); (6) manufacturer, as holder of an approved NDA under FDCA §505 or BLA under PHSA §351; (7) open, non-exclusive license, authorizing any person to use patents or regulatory data for a brand name drug; and (8) Secretary, as the HHS Secretary.