H.R. 3493 — Global Fairness in Drug Pricing Act

This section directs the Secretary of Health and Human Services (HHS), in coordination with the Centers for Medicare & Medicaid Services Administrator and other agency heads, to propose within 30 days of enactment a rulemaking plan imposing most-favored-nation price targets (i.e., prices comparable to those in other comparably developed countries) on pharmaceutical manufacturers. The section further requires the HHS Secretary to certify to Congress that personal importation of prescription drugs under section 804(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384(j)) poses no public health or safety risk and significantly reduces U.S. drug costs, and to facilitate consistent waiver grants for such case-by-case individual imports from low-cost developed countries. It also (1) directs the Attorney General and Federal Trade Commission Chair to enforce antitrust laws—including 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)—against pharmaceutical manufacturers' anticompetitive practices; (2) requires the HHS Secretary to facilitate direct-to-consumer purchasing programs for pharmaceuticals at prices set under the most-favored-nation rulemaking; and (3) requires the Secretary of Commerce and U.S. Trade Representative to study and report to Congress within 180 days on whether pharmaceutical manufacturers' acts, policies, or practices impair national security, force U.S. patients to subsidize global research and development, or suppress foreign drug prices below fair market value.