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The panel members will discuss the latest developments in the Xtandi petition case. Xtandi (enzalutamide) is a treatment for prostate cancer that is currently priced three to five times higher in the United States than it is priced in other similar high income countries. Prostate cancer patients Clare Love, David Reed, Robert Sachs, and Eric Sawyer, along with Universities Allied for Essential Medicines, filed a petition to ask that the government use its rights in the federally-funded patented inventions for Xtandi, in order to address the failure by the companies to make the drug “available to the public on reasonable terms.” On March 12, 2023, the NIH, acting on behalf of Secretary Becerra, rejected the petition. On March 23, 2023, the petitioners appealed the NIH decision to Secretacy Becerra.
Simultaneous to the NIH decision in the Xtandi petition, the Biden administration announced a government wide review of the march-in authority. From the HHS press release:
Most recently, the NIH declined a petition to initiate a march-in proceeding for the prostate cancer drug Xtandi®. . . .
Consistent with President Biden’s Executive Order on Promoting Competition in the American Economy, the DOC has not finalized any provisions on march-in rights in this revised rule that would have prohibited the government’s use of march-in solely on the basis of product pricing.
HHS will convene a workshop in 2023 to further refine the cases for which HHS could consider exercising march-in authority. HHS will seek input from a diverse array of stakeholders – including patient groups, industry, universities, small business firms, and nonprofit organizations, as well as experts in technology transfer and innovation policy. The goal of the workshop will be to assess when the use of march-in is consistent with the policy and objectives of the Bayh-Dole Act.
We have an excellent panel to discuss these developments and respond to questions from the online audience, including Professor Aaron Kesselheim from Harvard University, Marc Sedam, the former Chair of AUTM, Rob Weissman, the President of Public Citizen, Justin Mendoza, Executive Director of UAEM North America, and James Love of KEI.