Letter to HHS Secretary Xavier Becerra on need for generic competition on Xtandi

Coalition calls on Biden administration to use its authority to introduce competitors for prostate cancer drug

February 23, 2022 

The Honorable Xavier Becerra 


Department of Health and Human Services (HHS) 

200 Independence Avenue, S.W. 

Washington, D.C. 20201

Dear Secretary Xavier Becerra: 

We are writing to urge you to exercise the government’s rights in patents on the prostate drug Xtandi, to authorize generic competition. The current price discrimination against U.S. residents and the exorbitant price of almost $190,000 per patient per year violates the obligation to make the benefits of Xtandi’s patents “available to the public on reasonable terms.” 

Xtandi (generic name enzalutamide) was invented at UCLA on grants from the U.S. Army and the National Institutes of Health (NIH). Astellas, which markets Xtandi in the U.S. along with Pfizer, holds an exclusive license to use those patents worldwide. U.S. prostate cancer patients and private and government payers face staggering costs for the drug. In the first quarter of 2021, Xtandi cost Medicaid $149,460 per patient per year. In January of 2022, the U.S. average wholesale price per patient was $189,800 per year. In Japan, where Astellas is headquartered, the price is $30 thousand. For all high income countries besides the U.S. prices range from $30-$57 thousand. This is an extreme and unjustified price discrimination against U.S. residents, particularly when the drug was invented with U.S. taxpayers’ dollars. 

HHS has the authority to eliminate this price discrimination by telling Astellas that the U.S. government will use its march-in or government use rights in the Xtandi patents, unless the company agrees to sell the drug at prices that are reasonable. The petitioners in this case have proposed that the price ceiling be no higher than the median price charged in the seven countries with the largest GDP and at least half the per capita income of the United States. This is a very modest request considering the U.S. taxpayers have paid for the invention of the drug, which is the most risky element of drug development. We also note that cumulative Xtandi sales worldwide already exceed $20 billion, eliminating any possible concerns over the company making a sufficient profit. 

It is our understanding that the persons living with prostate cancer who have petitioned the government to exercise its rights in Xtandi to authorize generic competition have requested a public hearing on their request, in order to facilitate a transparent debate between supporters and opponents of the requested use of the government’s patent rights. The hearing that petitioners have requested would give Astellas and its partner Pfizer the opportunity to defend the decision to ask U.S. residents to pay $189,800 per year for this drug. The public should have the right to scrutinize any justification for the price discrimination against U.S. patients.

For 42 years, the United States has failed to use the Bayh-Dole Act march-in or government use rights to address abusive pricing of taxpayer-funded inventions. It is impossible to claim that in 42 years there have been no pricing abuses on federally-funded pharmaceutical inventions. Instead, it seems as though government officials have abused their responsibility to protect the public against “unreasonable use of inventions”, contrary to the Policy and Objective of the Bayh-Dole Act. See 35 U.S.C. § 200. 

Please advise us of the measures that HHS will take to protect the public from the outrageous and correctible price discrimination against U.S. residents. 


The Undersigned 

Organizations (alphabetically): 

● The American Medical Student Association (AMSA) 

● Center for Popular Democracy 

● Consumer Action 

● Democracy Collaborative 

● Doctors for America 

● Health Care Voices 

● Health Care Voter 

● I-MAK 

● Indivisible 

● Knowledge Ecology International (KEI) 

● NETWORK Lobby for Catholic Social Justice 

● Public Citizen 

● R2H Action [Right to Health], USA 

● Social Security Works 

● UMMA Volunteer Project at UCLA 

● U.S. PIRG (Public Interest Research Group) 

● Universities Allied for Essentials Medicines (UAEM) 

Individuals (alphabetically): 

● Allen Black, Ph.D., J.D. Counsel, Petitioners for the March-In petition “In the case of Fabrazyme” ● Brook K. Baker, Professor, Northeastern U. School of Law; Honorary Research Fellow, University of KwaZulu Natal; Health GAP (Global Access Project) Senior Policy Analyst 

● Cathy Hurwit 

● Christopher J. Morten, PhD, JD, Associate Clinical Professor Law, Columbia Law School ● Dana Neascu, Lecturer, Columbia Law School

● Deborah S. Socolar, MPH 

● Liza Vertinsky, Associate Professor, Emory University Law School 

● Peter Arno, Economist, Senior Fellow and Director of Health Policy Research at the Political Economy Research Institute at the University of Massachusetts-Amherst

● Reshma Ramachandran, MD, MPP – Physician-Fellow, Yale National Clinician Scholars Program) 

CC: Lawrence A. Tabak, DDS, PhD, Acting Director, National Institutes of Health