UAEM Program Manager Featured in MLex on the US GAO March In Rule Analysis
March 5, 2026
Contact: Cassidy Parshall, cassidy@uaem.org
WASHINGTON, DC — In response to the Government Accountability Office’s report on Information on Draft Guidance to Assert Government Rights Based on Price, UAEM Program Manager, Cassidy Parshall, spoke to MLex about the critical importance of march-in rights as a tool to protect the public against the pharmaceutical industry’s price gouging.
In December 2023, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) released Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights for public comment. This guidance aims to support agencies in evaluating when to require licensing of a patent developed with federal funding and includes price as a relevant factor for agencies to consider.
Under the Bayh-Dole Act, recipients of federal funding are able to retain the patent rights to the resulting invention, but to ensure the invention is made available to the public, the government has the ability to “march in” on those rights under specific circumstances, such as when there is a health or safety need. Despite the potential of this tool to protect the public interest, agencies have declined all requests to exercise march-in rights.
Responding to a request to review the development of NIST’s guidance and its potential impacts, the Government Accountability Office (GAO) released a report on the draft guidance in February 2026. In the report, GAO found that the finalized guidance does not currently have a timeline, with NIST citing a lack of interagency consensus as the reason.
Experts have outlined key considerations for agencies when exercising march-in rights based on price, providing numerous proposals that support the feasibility of implementation. Finalized guidance from NIST, including defined ways to incorporate price as a factor for triggering march-in rights, is critical to ensuring that the reasonable terms condition under Bayh-Dole is fulfilled. The continued stalling of this guidance, as indicated by the February 2026 GAO report, leaves patients vulnerable to ongoing pricing abuses for taxpayer-funded medicines with patents subject to Bayh-Dole.
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