WASHINGTON, D.C. – December 12, 2023 – The National Institutes of Standards and Technology proposed new guidance late last week that seeks to expand conditions under which federal government agencies can apply march-in rights, a provision of the 1980 Bayh-Doyle Act, to include consideration for pricing of pharmaceutical drugs.
A statement on behalf of Dr. Karen E. Knudsen, CEO of the American Cancer Society and American Cancer Society Cancer Action Network (ACS CAN) follows:
“While we share the administration’s goal of lowering drug costs, we remain concerned about the utilization of march-in authority as an avenue to make prescription drugs more affordable for the patients we serve as well as its long-term potential to deter private and public research partnership that has been key to our nation’s progress in the fight against cancer.
“The authority granted to federal agencies to take over patents of private companies was intended for rare, exceptional cases in which access to government research is not publicly available. While the administration’s intent may be to make drug therapies more accessible by lowering prices, invoking march-in authority on innovations supported in part by government funding could disrupt the existing highly efficient cancer bench to bedside translational ecosystem.
“Fostering continued cancer discovery is critical to addressing today’s unmet needs in cancer care and successfully combatting the more than 200 different diseases we call cancer by turning scientific advancements into effective therapies. We look forward to continuing to work with Congress and the administration to truly address the high costs of cancer by carefully balancing patient affordability and innovation, including submitting comments on the newly proposed framework.”
