Regulate the Price of All Drugs Act

Overview

HR 9040, the Regulate the Price of All Drugs Act, introduces a new federal framework to set and enforce “fair prices” for approved prescription drugs. The bill creates a dedicated regulatory commission, outlines how fair prices are recommended and published each year, and establishes enforcement mechanisms, penalties, and limited government countermeasures to protect access and competition.

Main purpose and intent

• Establish a formal process to determine and publish fair prices for all approved prescription drugs.
• Ensure broad access to drugs at or below these fair prices for individuals, pharmacies, hospitals, and providers in the United States.
• Provide tools to address price changes, supply/demand shifts, patent issues, and national security considerations (e.g., defense production act authorities) to maintain access.

Key provisions and changes

• Prescription Drug Price Regulatory Commission (Section 2)

  • Creates a 13-member Commission to determine fair drug prices.
  • 7 presidentially appointed outside members; 6 ex officio members from federal agencies (VHA, Defense Health Agency, CMS, FDA, CDC, FTC).
  • Commission recommendations are used to set fair prices and may propose revisions or temporary waivers.
  • Commission operates independently of Chapter 10 of Title 5 (not subject to that specific federal process).

• Publication and adjustments of fair prices (Section 3)

  • Secretary of HHS publishes the fair price for each approved drug annually, based on Commission recommendations.
  • Prices are intended to be accessible to fair-price-eligible individuals and to all dispensing providers during the applicable year.
  • The Secretary may revise prices after publication if warranted by Commission recommendations or significant changes in supply/demand or other factors.

• Temporary price waivers (Section 3)

  • The Secretary may authorize a 90-day price waiver (extendable) to maintain access if necessary.

• Penalties for noncompliance (Section 3)

  • Civil penalties for manufacturers that fail to provide access at or below the fair price.
  • Penalties are 10 times the product of units dispensed times the price difference, per year, per drug.
  • Applies similar enforcement mechanics to penalties under related federal law (SSA 1128A provisions).

• FDA enforcement and fair-price-based prohibitions (Section 4)

  • Adds new prohibition in the FD&C Act against selling or offering to sell a drug above the published fair price.
  • FTC enforcement role: treats violations as unfair or deceptive acts or practices; FTC empowered to enforce with applicable penalties and remedies.
  • State actions permitted; states may intervene, seek damages, or injunctions with FTC coordination.

• March-in rights for patents (Section 5)

  • If a patent owner profits above the fair price or fails to meet demand at the fair price, HHS may grant licenses to others in reasonable terms.

• Defense Production Act authority (Section 6)

  • President may use DPA authorities to increase domestic drug production if necessary to meet fair-price–based demand and if foreign supplies are insufficient.

• Definitions (Section 7)

  • Defines terms including “approved prescription drug,” “comparable reference country” (Canada, France, Germany, Italy, Japan, UK), “fair price applicability year” (starting 2027), “fair price eligible individual,” and related timelines (fair price publication date July 1 preceding year; recommendation date May 1 preceding year).

Who/what would be affected

• Approved prescription drugs (including biologics, insulin, vaccines) and their manufacturers.
• Patients and purchasers in the United States who would access drugs at the fair price.
• Dispensers (pharmacies, mail-order services), hospitals, physicians, and other providers administering drugs.
• Federal agencies (coordinating ex officio members) and potentially state attorneys general.
• Drug developers and pharmaceutical companies due to price controls, potential patent licensing actions, and enforcement tools.
• Domestic drug supply chains could be mobilized under DPA if shortages arise.

Procedural and timeline notes

• Fair price recommendation date: May 1 (preceding year).
• Fair price publication date: July 1 (preceding year).
• Fair price applicability year begins in 2027.
• Temporary waivers last up to 90 days, with possible extensions.
• Enactment and implementation would require passage and presidential signature; authorizations for appropriations are broad to fund Commission activities.

This bill represents a comprehensive price-regulation approach combining a new commission, mandatory pricing, enforcement through the FTC and FDA, and potential government intervention in patents and production.