I Want a New (Generic) Drug: A Comparative Case for Shifting U.S. Generic Drug Policies to Increase Availability and Lower Healthcare Costs

Chriswell, Immer S | January 1, 2024

Enacted in 1984, Hatch-Waxman was intended to increase generic drug availability and make critical healthcare more affordable for Americans. In the nearly forty years following, while it has increased availability of drugs, it has also allowed drug originators to create avenues to profit in ways not intended when the original compromise was struck, undermining its success. Moreover, given a weak antitrust standard against reverse settlement payments proscribed in Actavis, the U.S. faces a dilemma to further improve access to generic medications in the future. The E.U.’s approach to generic drugs, while presently geographically fragmented, is simpler and has a clear antitrust standard against reverse settlement payments which can provide a touchstone for the U.S. to reform its policy to better achieve the goals originally sought in Hatch-Waxman.