HR3493-119

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

2. Drug pricing 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. 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. 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. 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). 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— impairs national security; forces patients in the United States to subsidize global pharmaceutical research and development; or involves suppression of drug prices in foreign markets below fair market value.