WASHINGTON, D.C. – Yesterday, U.S. Senator Shelley Moore Capito (R-W.Va.), Ranking Member of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS), joined a group of 16 of her Republican colleagues to send a letter raising serious concerns to National Institutes of Health (NIH) Director Monica Bertagnolli, M.D. following President Biden’s proposal that attempts to allow agencies to seize drug patents under the Bayh-Dole Act if the administration views the price the company is charging as too high. 

This effort was led by U.S. Senator Bill Cassidy M.D. (R-La.), Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee. The senators expressed concerns that if the agency illegally uses “march-in” rights, it will severely hamper health care innovation and deny millions of Americans future lifesaving cures and treatments. 

“A short-sighted decision to exercise march-in rights would work against your stated goal and jeopardize patient access by discouraging individuals from partnering with NIH to develop new cures and treatments,” the senators wrote. “Not only will this hurt patients, but it will also diminish the return the public gets on the investments Congress makes in NIH each year – something we should all seek to optimize.” 

“We share the bipartisan goal of wanting to lower drug prices for American patients and families. But using march-in rights to address drug prices would do more harm than good,” the senators continued. “Agencies, including NIH, should not abuse their authorities to illegally seize intellectual property, and in the process jeopardize the valuable public-private partnerships that make our biomedical research enterprise the best in the world.” 

BACKGROUND:

The authors of the Bayh-Dole Act, former U.S. Senators Birch Bayh (D-Ind.) and Bob Dole (R-Kan.), made clear that the legislation “did not intend that government set prices on resulting products. The law makes no reference to a reasonable price that should be dictated by the government.” 

Ranking Member Cassidy also requested the Government Accountability Office (GAO) determine whether the Biden proposal meets the definition of a rule under the Congressional Review Act (CRA), which would make it eligible to be overturned by a CRA resolution of disapproval. 

When Dr. Bertagnolli was asked during her nomination hearing if she supported the use of march-in rights to influence drug costs, Dr. Bertagnolli responded that she would “follow all the laws of our land.” In addition to the congressional intent of the Bayh-Doyle Act, past Republican and Democratic presidential administrations have repeatedly affirmed that agencies lack the authority to use Bayh-Dole to seize patents in response to commercial drug costs. 

Additionally, the use of march-in rights based on drug prices could have drastic impacts on the development of new cures and treatments. In response to the Biden proposal, the nonpartisan Bayh-Dole Coalition stated that the framework “would discourage critical public-private partnerships and prevent thousands of transformational discoveries from reaching consumers.” America’s universities and other research institutions, where the vast majority of NIH-funded research takes place, have previously denounced the use of march-in rights as an “ineffective mechanism to reduce drug prices” that will “significantly undermine university innovation.” 

Read the full letter to NIH Director Monica Bertagnolli here.

Read Ranking Member Cassidy’s full letter to the GAO here. 

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