119 HR 3493 IH: Global Fairness in Drug Pricing Act U.S. House of Representatives 2025-05-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 119th CONGRESS1st Session H. R. 3493 IN THE HOUSE OF REPRESENTATIVES May 19, 2025 Mr. Khanna (for himself, Mrs. Luna, Ms. Kaptur, and Mr. Biggs of Arizona) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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 A BILL To reduce prescription drug prices by aligning U.S. prices with international benchmarks.

1.

Short title

This Act may be cited as the Global Fairness in Drug Pricing Act.

2.

Drug pricing

(a)

Most-favored nation price targets

Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall, in coordination with the Administrator of the Centers for Medicare & Medicaid Services and other heads of relevant Federal agencies—propose a rulemaking plan to impose most-favored-nation price targets to pharmaceutical manufacturers to ensure that prices for pharmaceutical products paid by patients in the United States are comparable to the prices for such products paid by comparably developed countries. (b)

Importation by individuals

The Secretary of Health and Human Services shall certify to Congress that importation under section 804(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j)) will pose no risk to the health and safety of the public and will result in a significant reduction in the cost of prescription drugs to the American patients in the United States; and the Secretary of Health and Human Services shall take action under section 804(j)(2)(B) of such Act to describe circumstances under which waivers will be consistently granted to individuals to import prescription drugs, on a case-by-case basis, from developed countries with low-cost prescription drugs. (c)

Enforcement actions

The Attorney General and the Chair of the Federal Trade Commission shall, to the extent consistent with law, undertake enforcement action against any anticompetitive practices by pharmaceutical manufacturers, including through enforcement of sections 1 and 2 of the Sherman Act (15 U.S.C. 1, 2) and section 5 of the Federal Trade Commission Act (15 U.S.C. 45), as appropriate. (d)

Programs enabling direct-to-Consumer purchases

To the extent permitted by law, the Secretary of Health and Human Services shall facilitate direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their pharmaceutical products to patients in the United States at the prices determined through the rulemaking under subsection (a). (e)

Study of unreasonable or discriminatory behaviors of manufacturers

The Secretary of Commerce and the United States Trade Representative shall conduct a study to determine whether any act, policy, or practice by pharmaceutical manufacturers constitutes unreasonable or discriminatory behavior that— (1)impairs national security; (2)forces patients in the United States to subsidize global pharmaceutical research and development; or (3)involves suppression of drug prices in foreign markets below fair market value.The findings of such a study shall be submitted in a report to Congress not later than 180 days after the date of the enactment of this Act.