Lexology December 8, 2023
Axinn Veltrop & Harkrider LLP

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the Department of Commerce to allow federal agencies to consider the price of a drug product when evaluating whether the federal government should use march-in rights under the Bayh-Dole Act to license other manufacturers to make a product whose R&D was supported by taxpayer funds. Although the Bayh-Dole Act has been on the books for a long time in which we have seen significant public-private partnerships developing beneficial therapies and prophylactics, the federal government has never considered price to be a factor when determining whether a federally-funded product...

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