Federal agency refuses to step in and require genetic competition for expensive, prostate cancer drug
The National Institutes of Health will not take action to authorize generic competition for an expensive, patented, and taxpayer-funded prostate cancer treatment, Francis Collins, director of the NIH, said Monday.
The drug, enzalutamide, is sold as Xtandi by only one company, the Japanese corporation Astellas Pharma.
Researchers at the University of California, Los Angeles, developed the medication with support from U.S. taxpayers. Astellas Pharma charges more than $129,000 per person per year for Xtandi in the United States.
Two consumer and patient advocacy organizations, Knowledge Ecology International and the Union for Affordable Cancer Treatment, had called on the NIH to exercise its “march-in” rights under the Bayh-Dole Act, to introduce generic competition and lower the price.
When Americans, through government, pay for the research and development costs that lead directly to the invention of a medication, they have the right to expect it will be priced reasonably when they, their insurers, or their government must purchase it, said Public Citizen, a consumer advocacy group.
“In the case of Xtandi, as so many others, not only has Astellas not priced the medication reasonably, it is charging more in the United States than other countries,” said Robert Weissman, president of Public Citizen. “There’s no reason the United States has to be a sucker in the deal.”
The government has the power to “march in” and authorize generic competitors to start making the medication – a move that would slash prices.”
Public Citizen wanted the NIH to hold a public hearing to have discussion of the issues raised on Xtandi, its price, and access.