Health Affairs February 5, 2024
“When drug companies won’t sell taxpayer-funded drugs at reasonable prices, we will be prepared to allow other companies to provide those drugs for less.” That is the rationale announced by the Biden Administration for creating a new bureaucracy intended to lower the price of prescription drugs discovered with federal funding. It sounds like a perfectly reasonable idea. But it is unworkable. The government has no authority to expedite Food and Drug Administration (FDA) approval of lower-cost generic drugs and its rights under patents created with federal funding are insufficient to overcome the private patent thickets that protect most federally funded drug discoveries.
Under the Bayh Dole Act, inventions created with federal funds belong to the academic institution that discovers them....
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