Warren worked with a group of more than 25 experts in law and public health from Yale Law School, Harvard Medical School, and Columbia Law School to explain the three options the administration has at its disposal, and urged Becerra to to “move swiftly to use your existing authorities to give sorely needed relief to the millions of Americans paying far too much for their prescription drugs.”
“Existing law gives the executive branch several tools to intervene when patients and public health are harmed by excessive drug prices,” the experts explained in their own letter to Warren last week. “These tools can help the Administration break patent barriers, foster competition where currently there is none, and drive down prices. Critically, using them requires no additional congressional action.”
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One of the three tools they discuss is the “government patent use power,” which has been used by the government “to procure important patented technologies from manufacturers other than the patent holders, who may charge very high prices.” They provide the example of the Pentagon using it to purchase technology like night-vision goggles. The other two options for executive action are provided under the 1980 Bayh-Dole Act, “intended to ensure that the public would not be deprived the benefits of inventions that it had effectively sponsored through government-funded research.” Through both “royalty-free license” and “march-in rights” established in that act, the government can break patent barriers for drugs developed with federal research money—and many, many pharmaceuticals fall into that category.
“In our view, § 1498 [the ‘government patent use power’] is a powerful general-purpose tool to target excessive pricing, while the Bayh-Dole Act is particularly helpful for patents that received government research support,” the experts write. “We believe that the two can and should be used together as part of a cohesive strategy when drugs of high public health importance are sold to US patients at excessive prices.”
Democrats and advocacy groups have been ramping up the pressure on Biden to take all the executive actions available, from immigration to canceling student debt, combatting the climate crisis, reducing fossil fuel dependence, investing in care economy jobs and standards, and regulating for economic and tax fairness. Biden has acted on Affordable Care Act premium costs, on ghost guns, and on environmental issues, but not on some of the really big stuff—the really big stuff he was imagining in Build Back Better.
Here’s one option for him from Warren, at least one item from Biden’s big agenda that can be salvaged immediately—Manchin and Sinema be damned.