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.
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