U.S. Sen. Bill Cassidy (R-LA) this week led two letters condemning what he says are efforts by the Biden administration to seize the patents of certain high-priced medicines.
In the first March 4 letter — which Sen. Cassidy and 16 of his Republican colleagues sent to National Institutes of Health (NIH) Director Dr. Monica Bertagnolli — the lawmakers expressed concern with the National Institute of Standards and Technology’s (NIST) Dec. 8, 2023, publication of draft guidance for how agencies should decide whether to exercise “march-in” rights to seize intellectual property related to federally funded research under the Bayh-Dole Act.
“As you know, the public comment period for the draft framework ended on Feb. 6,” wrote the senators. “During your confirmation hearing for the role of director of the NIH, you stated that you would “follow all the laws of our land.” In this case, the laws are clear: the Bayh-Dole Act does not allow the NIH or any other agency to use march-in rights in response to a product’s commercial pricing.”
Among the lawmakers who joined Sen. Cassidy in signing the letter were U.S. Sens. Joni Ernst (R-IA), Marsha Blackburn (R-TN), Roger Wicker (R-MS), Shelley Moore Capito (R-WV), and Susan Collins (R-ME).
The lawmakers also wrote that the use of march-in rights based on drug prices could have drastic impacts on the development of new cures and treatments, and added that America’s universities and other research institutions, where the vast majority of NIH-funded research takes place, previously have denounced the use of march-in rights as an “ineffective mechanism to reduce drug prices” that will “significantly undermine university innovation.”
Sen. Cassidy and his colleagues worry that if the agency illegally uses march-in rights, it will severely hamper healthcare innovation and deny millions of Americans future life-saving 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,” wrote the senators. “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.”
They added that 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 the nation’s biomedical research enterprise the best in the world.
In another March 4 letter, Sen. Cassidy, ranking member of the U.S. Senate Health, Education, Labor, and Pensions Committee, also requested that the Government Accountability Office 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.