NIH Refuses to Employ “March-In” Rights in Petition to Lower Cancer Drug Costs
Last week, the National Institute of Health denied petitions to use their authority to lower the cost of the cancer drug, Xtandi.[1] Xtandi is a prostate cancer drug produced by Pfizer and Astellas Pharma.[2] The controversy began when a patient group filed a petition for the National Institute of Health to use “march-in” rights to lower the price of Xtandi in March of 2016.[3] Currently, Xtandi costs about $189,000 for a year’s supply.[4] Proponents of lowering the cost of Xtandi rely on the Bayh-Dole Act (“Act”) for the government to exercise its authority.[5]
March-In Rights
The Act enables march-in rights,[6] which allow the government to take actions “necessary to alleviate health or safety needs which are not reasonably satisfied by [a] contractor, assignee, or their licensees.”[7] March-in rights are one of the more controversial aspects of the Bayh-Dole Act. Advocates of affordable healthcare access have argued that these rights should be used to help lower drug prices, which are disproportionately funded by taxpayer dollars.[8] So far, the National Institute of Health has been petitioned several times to execute march-in rights.[9] However, the National Institute of Health has denied each and every one of these petitions.[10] The refusal to exercise march-in rights often comes down to the statutory interpretation of the Act.[11] It is viewed that these march-in rights should be interpreted narrowly so as to only apply to very few and severe circumstances as specifically outlined in the statute.[12] However, others have opined that these march-in rights should be employed specifically in the pharmaceutical industry.[13] Some believe that the Bayh-Dole Act is an initial starting point to help establish and improve accountability within the Big Pharma industry.[14] When significant taxpayer dollars are used to help develop and create pharmaceutical and medical inventions, many believe the public deserves more rights to those inventions.[15] However, the Bayh-Dole Act has not been used to “march-in” on any invention.[16]
Xtandi and Bayh-Dole
Xtandi was developed using significant funding from the Pentagon and the National Institute of Health at the University of California, Los Angeles.[17] The original petition requests the National Institute of Health to license the patent for Xtandi to other companies so increased production can cause a decrease in price.[18] Senators Elizabeth Warren and Angus King have pressed the National Institute of Health to exercise their march-in rights to lower prices for Xtandi.[19] However, earlier this week, the National Institute of Health denied these petitions.[20] In response, petitioners have filed a request with the Department of Health and Human Services for an additional agency to review the decision.[21]
In response to increased pressure on Capitol Hill, the Biden Administration has established a joint effort between the U.S. Department of Health and Human Services and the Department of Commerce to review march-in rights.[22] These agencies will develop a plan to implement march-in rights going forward, with the goal of clearly outlining the criteria, framework, and assessment protocol for implementation of march in rights.[23]
Footnotes
