Patient advocates on Tuesday blasted the Biden administration's refusal to compel the manufacturer of a lifesaving prostate cancer drug developed completely with public funds to lower its nearly $190,000 annual price tag.
In 2021, prostate cancer patient Eric Sawyer petitioned U.S. Health and Human Services (HHS) Secretary Xavier Becerra to grant march-in rights—under which the government can grant patent licenses to companies other than a drug's manufacturer—for enzalutamide, which is sold under the brand name Xtandi by Pfizer and Japanese pharmaceutical giant Astellas.
The drug's development was 100% taxpayer-funded. Yet a one-year supply of Xtandi currently costs $189,800 in the United States, or up to five times more than its price in other countries.
HHS' National Institutes of Health (NIH) said Tuesday that it "does not believe that use of the march-in authority would be an effective means of lowering the price of the drug."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable."
The agency added that it "will pursue a whole-of-government approach informed by public input to ensure the use of march-in authority is consistent with the policy and objective of the Bayh-Dole Act," a reference to legislation meant to promote the commercialization and public availability of government-funded inventions.
James Love, director of the Washington, D.C.-based advocacy group Knowledge Ecology International, called the administration's rejection "appalling."
"What the Biden administration is saying is that charging U.S. residents three to six times more than any other high-income country is reasonable," he wrote.
U.S. Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-Vt.) said in a statement that he is "extremely disappointed that the Biden administration denied a petition by prostate cancer patients to substantially reduce the price of Xtandi."
"This is a drug that was invented with taxpayer dollars by scientists at UCLA and can be purchased in Canada for one-fifth the U.S. price," Sanders added. "The Japanese drugmaker Astellas, which made $1 billion in profits in 2021, has raised the price of this drug by more than 75%... How many prostate cancer patients will die because they cannot afford this unacceptable price?"
Rep. Lloyd Doggett (D-Texas), the ranking member of the House Ways and Means Health Subcommittee, said in a statement:Today's decision is a blow to prostate cancer patients, their families, and taxpayers. Developed with U.S. taxpayer research dollars, Xtandi costs American patients $180,000 a year—as much as six times as much as patients in other countries. This excessive price gouging cost taxpayers $2 billion to cover Medicare beneficiaries' treatment in 2020 alone. The Biden administration has missed yet another opportunity to do something meaningful to lower prescription drug costs and protect taxpayer investments.
The administration's position "protects monopolists over taxpayers and patients, despite clear statutory authority and reasonableness to intervene," Doggett added. "This decision effectively rubber-stamps continued Big Pharma abuse."
In a move that Public Citizen president Robert Weissman called "pathetic," HHS and the Department of Commerce announced Tuesday that they would "pursue a whole-of-government approach to review... march-in authority as laid out in the Bayh-Dole Act" by forming an interagency working group.
The group "will develop a framework for implementation of the march-in provision that clearly articulates guiding criteria and processes for making determinations where different factors, including price, may be a consideration in agencies' assessments."
In a statement, Becerra said that the administration is "committed to increasing access to healthcare and lowering costs."
"March-in authority is a powerful tool designed to ensure that the benefits of the American taxpayers' investment in research and development are reasonably accessible to the public," he added. "We look forward to updates from the Bayh-Dole Interagency Working Group, and at my direction, HHS will review the findings, engage the public, and better define how HHS could effectively utilize our authority moving forward."