Prescription Drug Price Relief Act of 2025
- Bill Number
- H.R. 3546
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-05-21: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-03-24T18:25:08Z
AI-Generated Summary
Purpose of the Legislation
The Prescription Drug Price Relief Act of 2025 aims to reduce prescription drug costs for U.S. patients by identifying brand-name drugs priced excessively high compared to international benchmarks and ending certain government protections that allow manufacturers to maintain monopolies on those drugs. This would enable faster entry of lower-cost generic or similar versions into the market.
Key Provisions
- Identification of Excessively Priced Drugs (Section 2): The Secretary of Health and Human Services (HHS) must review all brand-name drugs at least once a year, starting 30 days after enactment. A drug is deemed excessively priced if its average U.S. manufacturing price exceeds the median price in at least three of five reference countries (Canada, UK, Germany, France, Japan). For drugs without sufficient international data, pricing is evaluated based on factors like patient population size, drug value to patients, federal subsidies received, development costs, health outcome improvements, global revenues, and U.S. price increases beyond inflation. Anyone can petition HHS for a review (limited to once per year per drug), with decisions made public.
- Ending Monopolies for Excessively Priced Drugs (Section 3): If a drug is found excessively priced, HHS must immediately cancel government-granted exclusivities (e.g., periods where generics cannot be approved) and issue open, non-exclusive licenses allowing any entity to produce, sell, or import the drug using the original's regulatory data. FDA must expedite reviews of generic or biosimilar applications (within 8 months). HHS can sue manufacturers for damages if they raise prices after a determination but before generics enter the market.
- Licensing Requirements (Section 4): License holders pay a "reasonable royalty" to the original patent holder or manufacturer, set as a percentage of sales (no higher than the average from IRS tax data for pharma) or based on factors like patient value, federal investments, and recovered costs. Royalties must ensure the drug sells at affordable prices below the excessive U.S. price level. If multiple patent holders exist, royalties are split fairly.
- Public Database and Reporting (Section 5): HHS must create and maintain an online database listing all brand-name drugs, excessive price determinations, petitions received, licenses granted, and application approvals. Annual reports to Congress summarize reviews, affected drugs, license numbers, approval times, and manufacturer compliance.
- Manufacturer Reporting (Section 6): Drug manufacturers must submit annual reports by January 15 detailing U.S. and international prices, revenues, R&D and marketing costs, clinical trial investments (including federal subsidies), patient population estimates, and pricing methodologies. Non-compliance or false reporting incurs civil penalties (0.5-1% of the drug's prior-year U.S. sales revenue per day late), with funds supporting NIH research grants.
- Prohibition on Anticompetitive Behavior (Section 7): Manufacturers cannot engage in actions that violate antitrust laws (under the Federal Trade Commission Act) to block licenses or affordable drug access.
- Definitions (Section 8): Key terms include "average manufacturer price" (U.S. wholesale cost or equivalent abroad), "brand-name drug" (patented, FDA-approved drugs with exclusivity), "generic drug" (lower-cost copies), "open non-exclusive license" (broad permission to use patents and data), and "government-granted exclusivity" (legal protections delaying competition).
Significant Changes to Existing Law
- Introduces mandatory international price comparisons (using a "reference pricing" model from five countries) as a primary trigger for action, which is not currently required under U.S. drug laws like the Federal Food, Drug, and Cosmetic Act.
- Authorizes HHS to override or cancel patent-related exclusivities and issue compulsory (government-mandated) licenses for high-priced drugs, fundamentally altering intellectual property protections under patent law and FDA exclusivity rules (e.g., Hatch-Waxman Act provisions).
- Imposes new, detailed annual reporting requirements on manufacturers, expanding beyond existing transparency rules (e.g., under Medicare or Medicaid), with penalties funding public research.
- Expedites FDA generic/biosimilar approvals specifically for affected drugs, shortening standard timelines (typically 10-30 months) to 8 months.
Potential Impacts
- On Citizens: Could lower out-of-pocket and insurance costs for brand-name drugs by accelerating generic competition, improving access for patients with chronic conditions, though short-term supply disruptions or litigation might delay benefits.
- On Government Agencies: HHS and FDA gain significant new responsibilities for pricing reviews, licensing, database maintenance, and lawsuits, potentially straining resources. Congress receives detailed oversight data. Penalties fund NIH grants, indirectly supporting public health research. The FTC could see increased enforcement against pharma antitrust issues.
- On International Relations: Relies on pricing data from Canada, UK, Germany, France, and Japan, which might pressure these countries to share information or face indirect U.S. policy ripple effects; could influence global drug pricing negotiations but is unlikely to directly harm relations.
Main Stakeholders Affected
- Patients and Consumers: Primary beneficiaries through potential price reductions and better drug access.
- Drug Manufacturers: Brand-name companies face lost monopolies, revenue hits, and reporting burdens; generic and biosimilar producers gain opportunities for quicker market entry.
- Healthcare Payers: Insurers, Medicare, Medicaid, and employers could save billions on drug costs.
- Government Entities: HHS, FDA, and NIH handle implementation and benefits; Congress oversees via reports.
- Healthcare Providers: Doctors and pharmacies may see more affordable options but could face initial confusion from rapid market changes.
Notable Legal, Constitutional, or Political Implications
- Legal: Establishes compulsory licensing akin to mechanisms in some international trade agreements (e.g., WTO rules for public health emergencies), but applied broadly to pricing; could invite lawsuits over patent infringement, data exclusivity violations, or arbitrary HHS decisions (e.g., under Administrative Procedure Act standards for rulemaking).
- Constitutional: May raise Fifth Amendment "takings" claims if canceling exclusivities is seen as seizing private property (patents) without just compensation; royalty payments aim to mitigate this, but courts could scrutinize their adequacy.
- Political: Targets pharmaceutical industry pricing power, potentially polarizing debates between consumer advocates (favoring affordability) and industry groups (arguing it discourages innovation); as an introduced bill (H.R. 3546, 119th Congress), it faces committee review (Energy and Commerce, Judiciary) and could influence broader drug pricing reforms like those in the Inflation Reduction Act.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (4)
Rep. Schakowsky, Janice D. [D-IL-9], Rep. Jayapal, Pramila [D-WA-7], Rep. Omar, Ilhan [D-MN-5], Rep. Ansari, Yassamin [D-AZ-3]
Recent Actions
- 2025-05-21: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-05-21: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-05-21: Introduced in House
- 2025-05-21: Introduced in House
Bill Versions
- Prescription Drug Price Relief Act of 2025 — issued 2025-05-21 — PDF (20 pages)