Global Fairness in Drug Pricing Act
The Global Fairness in Drug Pricing Act aims to lower U.S. prescription drug costs by tying U.S. prices to international benchmarks and by giving federal agencies new tools to promote lower prices. The bill directs the Secretary of Health and Human Services (HHS), in coordination with the CMS Administrator and other agencies, to propose a rulemaking plan within 30 days to establish most-favored-nation (MFN) price targets. These targets would align U.S. drug prices with those paid by comparably developed countries. The bill also envisions increased drug importation by individuals under FDA rules, provided safety and substantial cost reductions are demonstrated, and it authorizes waivers on a case-by-case basis for importations from developed countries with lower drug costs. Beyond price setting and importation, the bill would empower antitrust and consumer protection authorities to pursue enforcement against anti-competitive practices by drug manufacturers, promote direct-to-consumer purchasing programs at the MFN-derived prices, and require a Commerce/USTR study on whether manufacturers engage in unreasonable or discriminatory behavior that could threaten national security, subsidize global R&D through U.S. patients, or suppress foreign prices below fair value. The overall goal is to reduce costs for American patients while preserving safety and encouraging competition.
Key Points
- 1Most-favored nation price targets: The bill requires HHS, with CMS and other agencies, to propose a rulemaking plan to impose MFN price targets so U.S. prices reflect those in comparably developed countries.
- 2Importation by individuals: HHS must certify that drug importation under current law poses no health risk and would significantly cut costs, and it must outline when waivers would be granted on a case-by-case basis for imports from low-cost developed countries.
- 3Enforcement against anti-competitive practices: The Attorney General and FTC Chair would, as appropriate, pursue enforcement under antitrust and competition laws (Sherman Act sections 1 and 2, and FTC Act section 5).
- 4Direct-to-consumer purchasing programs: To the extent allowed by law, HHS would facilitate programs that allow patients to buy drugs at MFN-derived prices directly from manufacturers.
- 5Study of manufacturer behavior: The Commerce Department and USTR would study whether manufacturers engage in unreasonable or discriminatory actions (threatening national security, shifting R&D subsidies, or suppressing foreign prices) and report findings within 180 days of enactment.