March-In Rights to Control Prices and Stimulate Competition Supported by FTC

FTC has waded into the march-in rights fracas, supporting the obscure Bayh-Dole Act as a tool to moderate drug pricing and control patent thickets on drugs developed with federal funding.

“Development of pharmaceutical products in the United States has long benefited from taxpayer support, with a substantial number of breakthroughs in drug development stemming from government-funded research,” the FTC said in its statement of support. “NIH funding directly or indirectly contributed to every one of the 210 new molecular entities approved from 2010-2016 … [and] 354 of 356 new drugs approved by the FDA from 2010 to 2019,” the statement said. “In light of the federal government’s substantial investment in public health, Americans deserve to have affordable access to the prescription drugs that billions of taxpayer dollars paid to develop.”

The comment comes in response to the Biden Administration’s December call to invoke the Bayh-Dole Act of 1980’s “march-in” rights to control drug pricing and stimulate generics competition. The act allows the federal government to grant additional manufacturing licenses for patented medicines that were developed using federal funds. If a drug company isn’t charging a reasonable price for a drug, or if its pricing harms public health by substantially restricting access to the drug, the federal government can use march-in rights to increase availability of cheaper generic versions.

Read the FTC statement of support here.

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