H.R. 3391 — End Price Gouging for Medications Act

This section requires the Secretary of HHS to establish annual reference prices for each prescription drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or subsection (a) or (k) of section 351 of the Public Health Service Act (42 U.S.C. 262). The reference price is the lowest retail list price for the drug among 12 countries (Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, the Netherlands, Sweden, Switzerland, and the United Kingdom) if pricing data are available for at least three; otherwise, it reflects the drug's therapeutic effect, value, patient access, research costs, and other factors determined by the Secretary. The section caps retail list prices at the reference price for enrollees in Medicare (title XVIII of the Social Security Act), Medicaid (title XIX), CHIP (title XXI), TRICARE (10 U.S.C. ch. 55), VA health care (38 U.S.C. chs. 17, 18), FEHBP (5 U.S.C. ch. 89), and Indian health programs (25 U.S.C. 1601 et seq., including under 25 U.S.C. 5304 et seq.). It further requires drug manufacturers to offer such drugs at the reference price to all individuals, including the uninsured and those under group or individual health plans (where plan coverage plus cost-sharing does not exceed the reference price). Noncompliance with respect to federal health programs triggers civil penalties equal to five times the difference between amounts actually received by the manufacturer and amounts that would have been received if compliant; penalty amounts collected are transferred annually to NIH for drug research and development.