February 18, 2022

Warren, King, Doggett Urge HHS to Exercise March-in Rights for Life-Saving Cancer Drug Xtandi to Dramatically Lower its Price for Millions of Americans

Washington, D.C. - United States Senators Elizabeth Warren (D-Mass.) and Angus King (I-Maine), and Congressman Lloyd Doggett (D-Texas) sent a letter to Xavier Becerra, Secretary of the Department of Health and Human Services (HHS), urging him to move forward with the march-in petition submitted for the prostate cancer drug Xtandi. The lawmakers are urging Secretary Becerra to hold a public hearing on the Xtandi petition to allow petitioners and patent-holders to present arguments and accompanying evidence on this case.

“Exercising the government’s march-in rights for Xtandi will dramatically lower the price of this life-saving drug for millions of Americans,” the lawmakers wrote. 

March-in rights, established in the Bayh-Dole Act, allow the federal government to grant licenses to responsible applicants for products developed with federal grants, introducing competition and lowering prices for consumers. 

The lawmakers highlight HHS’ numerous public commitments to give petitions for the use of march-in rights due consideration. In response to a July 2021 letter from Senator Warren, Senator Amy Klobuchar (D-Minn.), and Congressman Lloyd Doggett , Secretary Becerra reiterated his commitment, suggesting that these rights could be used to lower drug prices for Americans. The present petition on Xtandi is a critical test case for HHS.  

Xtandi was developed at UCLA thanks to federal government grants from the U.S. Army and National Institutes of Health, but despite investment from U.S. taxpayers, the drug can cost Americans as much as six times what it costs individuals in other high-income countries. According to Knowledge Ecology International, the average wholesale price for one Xtandi capsule in the United States is $130, whereas the price of the same capsule of the drug in Japan is just over $20. The drug is intended for long-term use, and a typical course of treatment involves four pills taken daily: over the course of a year, the cost of Xtandi in the United States is nearly $160,000 higher than the drug’s price in Japan. 

“As the administration continues to stress the importance of lowering drug prices, we urge you to use existing executive authority to deliver meaningful relief to consumers. HHS should hold a public hearing on the Xtandi petition to allow petitioners and patent-holders to present arguments and accompanying evidence on this case, and then move forward to exercise the government’s march-in rights without delay,” the lawmakers wrote. 

Senator Warren has been a leading voice in Washington calling for lower prescription drug prices since joining the Senate in 2013. In June 2021, Senator Warren and her Senate colleagues questioned PhRMA's lobbying efforts to block policies that would lower drug costs for millions of Americans. Also, in that same month, Secretary Becerra told Senator Warren that HHS looks forward to working with Congress on lowering drug prices, expanding coverage to include vision, dental, and hearing services, and ensuring older Americans 60 and over receive Medicare coverage.