The AAMC has asked the Biden administration to withdraw a proposed framework that would guide federal agencies in exercising “march-in” rights under the Bayh-Dole Act. In comments submitted on Feb. 1, the association stated that the proposed framework would be ineffective as a price control for drugs or other products, but would make it more difficult for academic medical centers to license inventions and collaborate with industry, inhibiting future innovation. The AAMC and five other associations, representing the majority of pioneering academic research institutions, also submitted joint comments emphasizing that the proposed guidance runs contrary to the intent — and subsequent success — of Bayh-Dole in catalyzing the application of university-based inventions arising from federally funded research. The higher education associations had previously sent comments to Health and Human Services Secretary Xavier Becerra in support of decisions not to exercise march-in over drug pricing [refer to Washington Highlights, July 29, 2022].
The draft framework and request for public comments, to which the AAMC and joint associations responded, was released on Dec. 7 by the National Institute of Standards and Technology, the federal agency overseeing Bayh-Dole’s implementation [refer to Washington Highlights, Dec. 8, 2023]. All public comments on the proposal are due to the agency by 5 p.m. ET, Feb. 6.
- Washington Highlights