The NIH continues to agree with the public testimony in 2004 that the extraordinary remedy of march-in is not an appropriate means of controlling prices of drugs broadly available to physicians and patients.In 2010, the NIH also declined to implement a march-in when a KEI petition was filed to remedy the manufacturing shortage of Fabryzyme by Genzyme, Inc. Now, KEI has filed a march-in petition with NIH over the high pricing of the prostate cancer drug Xtandi (patents granted to the University of California; now assigned to Astellas Pharma):
This letter is a request that the U.S. federal government use its rights in patents for the prostate cancer drug (enzalutamide), marketed under the brand name of Xtandi by Japan-based Astellas Pharma. This is a product that has an average wholesale price (AWP) of $129,269 per year, and which is far more expensive in the United States than in other countries. Specifically, we ask the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), and/or the Department of Defense (DoD) to use its royalty free rights in the relevant patents, or to grant this request for march in rights. The relevant patents include, but are not limited to, the three patents listed in the FDA Orange Book for Xtandi (7,709,517, 8,183,274, and 9,126,941), all of which were granted to the Regents of the University of California, a public institution. All three inventions were made with the support of the United States government under National Institutes of Health SP ORE grant number 5P50CA092131 and Department of Defense (Army) grant number W81XWH0410129.What can be expected with this most recent march-in petition to the NIH? In an environment where drug pricing is high on the radar screen for patients and for physicians (see earlier post on "financial toxicity"), and where the U.S. generally does not subscribe to price controls in health care, the high cost of drugs – especially new, targeted drugs – is causing politicians and bureaucrats to pay more attention. In January, prior to the filing of the new KEI petition, 50 members of Congress wrote a letter to NIH, asking that the agency set true guidelines for when the exercise of march-in rights would be reasonable. Then, in a hearing in the House Ways and Means Committee last week, Department of Health and Human Services (HHS) Secretary Burwell stated that HHS would consider the request for march-in guidance from the legislators. In the current campaign season, efforts to control drug prices are already part of political platforms and discourse (see here, for example). But with respect to the dormant march-in authority granted to the federal government, it may be that HHS and/or NIH are more willing to consider all measures and now actually welcome the existence of a statutory authority long ignored. At the least, NIH could begin to clarify how the march-in provisions are to be interpreted. However, that is not to say that march-in rights are a wholesale solution to drug pricing (see here for one study on the limits of such authority). For example, the ability of the federal government to negotiate drug prices for Medicare is often proposed as a leavening force; Congress has explicitly banned that option but it could be rescinded (or possibly by executive order?). Because some of the new “precision medicine” drugs are the most expensive (especially cancer drugs), the disconnect between the promise of genetically-informed medical care and actual access to biotech drugs is growing. That asymmetry will only add to the pressure on both legislative and executive branches to incorporate drug pricing realities into the overarching project of health care access as exemplified by the Affordable Care Act (Obamacare).