[Ip-health] 11 Groups Urge NIH to Lower Price of Xtandi, NIH/Army-Funded Prostate Cancer Drug With $129k/Year Price Tag

Zack Struver zack.struver at keionline.org
Mon Mar 21 13:58:54 PDT 2016


Zack Struver
zack.struver at keionline.org
+1 (914) 582-1428


Non-Profit Groups Urge Obama Administration, NIH to Lower Price of
Government-Funded, $129,000 Per Year Prostate Cancer Drug

The groups asked the National Institutes of Health to “take this
opportunity to act” to lower the price of the prostate cancer drug Xtandi
and show leadership on deterring discriminatory pricing practices.

Washington, DC — Today, 11 public interest policy and advocacy
organizations sent a letter to the National Institutes of Health (NIH) in
support of a January petition submitted by Knowledge Ecology International
(KEI) and Union for Affordable Cancer Treatment (UACT), which asked the NIH
to use its statutory authority [1] to lower the price of an expensive
prostate cancer drug [2] that was developed with the support of federal

The letter is available here: http://goo.gl/sf0rbW. The groups included:

Center for the Study of Responsive Law
Universities Allied for Essential Medicines (UAEM)
American Medical Students Association (AMSA)
National Physicians Alliance (NPA)
Alliance for Retired Americans
Essential Information
Public Citizen
The Other 98%
Community Catalyst

Astellas Pharma, a Japanese pharmaceutical company, sells the
taxpayer-funded late-stage prostate cancer treatment, Xtandi
(enzalutamide), for over $129,000 per year in the United States. That price
is two to four times higher than the price in other high-income countries
such as the United Kingdom, Canada, and Germany.

Richard Fiesta, executive director of the Alliance for Retired Americans,

“It is outrageous that Xtandi, a cancer drug created as a result of
American taxpayer-funded research, is being sold in the United States for
$350 per day. This is far more than Astellas Pharma, the Japanese
manufacturer, is charging in other developed countries. We urge Director
Collins use his authority to make this cancer-fighting drug available to
the public by forcing the company to charge a reasonable rate.”

Two prominent researchers at the University of California, Los Angeles
(UCLA) — including Dr. Charles Sawyers, a Lasker Award winner who now sits
on the board of Novartis and runs a lab at Memorial Sloan Kettering Cancer
Center — developed Xtandi with the support of NIH and United States Army
grants, which funded phase 1 and 2 clinical trials that were later used to
secure FDA approval.

The non-profit organizations, which represent the interests of U.S.
taxpayers, consumers, and patients, as well as university students and
physicians, raised concerns about the discriminatory price of Xtandi, and
echoed the KEI and UACT request, noting that the NIH should exercise its
powers under the Bayh-Dole Act to lower the price of Xtandi, a late-stage
prostate cancer treatment.

Merith Basey, the Executive Director of Universities Allied for Essential
Medicines, said:

“The public shouldn't have to pay with their lives for a product they have
already funded with their tax dollars — we call on NIH and UCLA to leverage
their rights to ensure this drug is affordable for all,”

Jesse Ellis O’Brien, a health policy analyst with U.S. PIRG, said:

"People with prostate cancer should not be denied access to an effective
treatment because of prices that are higher than anywhere else in the
world. The National Institutes of Health should use the provisions of the
Bayh-Dole Act to remedy the unreasonable price of Xtandi, and to send a
message that pharmaceutical companies cannot set excessive prices for drugs
developed through taxpayer-funded research."

A 1980 law designed to facilitate technology transfers between non-profit
or public institutions and commercial firms, the Bayh-Dole Act also
includes safeguards to ensure that patented inventions are available to
people who need them in the United States. In their January letter to the
NIH, KEI and UACT asked the NIH to use either their royalty-free,
non-exclusive license on the patents on Xtandi, or its “march-in rights” to
declare the price of the drug unreasonable and allow generic manufacturers
to produce the drug for sale at an affordable price.

Robert Weissman, the President of Public Citizen, said:

“When Americans through their government pay for the research and
development costs that lead directly to the invention of a pharmaceutical
drug, 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 the beneficiary of U.S. government
largesse, Astellas, not priced the drug 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. The government retains the power to “march
in” and authorize generic competitors to start making the drug – a move
that would slash prices. The only question is whether the Obama
administration will permit the American people – and the American
government itself – to continue to be ripped off.”

The ten public interest groups wrote that while they “represent, among
others, taxpayers who gladly support the NIH budget because innovation is
important,” the NIH should heed public concerns that drug prices are too
high, explaining that “some answers may lie in plain view.”

Whether the NIH uses its march-in rights or royalty-free license on the
Xtandi patents, the groups urged 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,” stating that such a
hearing “is important to patients and consumers, and may have a deterrent
effect of its own right with regard to pricing, distinct from the outcome
of the NIH’s internal deliberations.”

Reshma Ramachandran, the FDA Task Force Co-Chair for the National
Physicians Alliance, echoed the call for a public hearing.

“Increasingly so, we have become witnesses to our patients’ struggles to
pay for lifesaving medicines, often at the expense of their other daily
needs,” Ramachandran said. “The National Physicians Alliance strongly
supports the call for the NIH to hold a public hearing as a first step to
address the growing issue of unaffordable drug pricing. Our patients should
not have to pay twice, first through taxes and then again in excessive
prices, to receive the drugs they need.”

Ralph Nader, who runs the Center for the Study of Responsive Law, said:

“The pharmaceutical industry spends far more on marketing and advertising
to physicians, hospitals, and patients than it spends on research and
development. Enormous drug industry funds go to lobbying politicians to
prevent the implementation of price restraints on its staggering markups.
Billions of U.S. taxpayer dollars and extensive tax credits annually
subsidize research that is used to develop drugs, yet the pharmaceutical
industry is allowed to endanger patients’ health by charging the public
exorbitant, unaffordable prices for drugs that are routinely sold for lower
prices in other countries. It is urgent to reign in the runaway
price-gouging of pharmaceutical products.”


Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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