“Today, the Biden-Harris Administration announced a new action to support lowering prescription drug costs and increase Americans’ access to life-saving medications: Promoting equitable access to lower-priced taxpayer-funded drugs. Taxpayers have spent hundreds of billions of dollars on research catalyzing the discovery and development of new prescription drugs. The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public. When an invention is made using taxpayer funds, under certain circumstances march-in authority under the Bayh-Dole Act enables the federal government to license the invention to another party. The prior Administration proposed a rule preventing the government from exercising this authority on the basis of high price alone. The Biden-Harris Administration decided not to finalize that proposal earlier this year, consistent with President Biden’s Executive Order on Promoting Competition in the American Economy. Today, the Department of Commerce (DOC) and HHS released a proposed framework for agencies on the exercise of march-in rights that specifies for the first time that price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public. DOC and HHS invite public input on how this framework can promote access to taxpayer-funded inventions, including treatments for patients, while promoting innovation.”
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The White House cited Ledley’s INET working paper on the NIH’s seed funding of FDA approved pharmaceuticals in their fact sheet on new actions to lower health care and prescription drug costs.
