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NIH Turns Its Back on Patients; Decision to Refuse Generic Competition With Xtandi Harms Public Health

June 20, 2016

NIH Turns Its Back on Patients; Decision to Refuse Generic Competition With Xtandi Harms Public Health

Statement of Public Citizen Experts

Note: Today, Director of the National Institutes of Health (NIH) Francis Collins announced that the NIH would not take action to authorize generic competition with an expensive, patented and taxpayer-funded prostate cancer treatment called enzalutamide, marketed exclusively by the Japanese corporation Astellas Pharma as Xtandi. Researchers at the University of California, Los Angeles, developed the lifesaving 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 upon the NIH to exercise its “march-in” rights under the Bayh-Dole Act, to introduce generic competition and lower the price. Public Citizen supported the request and called on the NIH to hold “a transparent, public hearing to have a serious and thorough discussion of the important issues raised regarding this drug, its price, and access.”

Statement of Robert Weissman, president of Public Citizen:

When Americans, through government, pay for the research and development costs that lead directly to the invention of a medication, they have every right to expect it will be priced reasonably when they, their insurers or their government must purchase it. 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. There’s no reason the United States has to be a sucker in the deal. Our government retains the power to “march in” and authorize generic competitors to start making the medication – a move that would slash prices.

Statement of Peter Maybarduk, director of Public Citizen’s Access to Medicines Program:

Today, NIH Director Collins once again passed on an opportunity to make medicines affordable, preferring to allow manufacturers to price gouge the public with the full blessing, and indeed the support, of our government.

Medicines are unaffordable because corporations abuse the monopoly powers we give them, through patents and other exclusivities. Until the U.S. government confronts this problem, we all will pay higher prices for the medicines we need. We also will pay higher insurance premiums and suffer further treatment rationing.

Ironically, the reforms that our government proposes to lower medication prices become ever more convoluted, because we fail to address the obvious core problem of pharmaceutical monopoly power and prices.