[Ip-health] Stat+: Lawmakers ask HHS to ensure Gilead’s remdesivir is affordable if U.S. taxpayers funded R&D

Thiru Balasubramaniam thiru at keionline.org
Sat May 2 04:56:06 PDT 2020


Lawmakers ask HHS to ensure Gilead’s remdesivir is affordable if U.S.
taxpayers funded R&D
MAY 1, 2020

Now that preliminary trial results indicate an experimental Gilead Sciences
(GILD) drug can successfully treat some Covid-19 patients, two lawmakers
want to know if U.S. taxpayer dollars helped pay for any of the research
and development and, if so, what the federal government will do to ensure
that Americans do not later encounter “price gouging.”

In a letter to the U.S. Department of Health and Human Services, Rep. Lloyd
Doggett (D-Texas) and Rep. Rosa DeLauro (D-Conn.) noted the National
Institutes of Health spent nearly $700 million on coronavirus research
overall and asked the HHS to provide information about various ways the
agency may have provided funding that contributed to development of the
Gilead drug, which is called remdesivir.

Specifically, they asked HHS about any grants to universities that
conducted research on the drug; R&D conducted by the NIH and other federal
agencies; clinical trials run or financed by the federal government; any
patents that the federal government owns or licensed for remdesivir, and
any funds that were provided to allow Gilead to scale up production for the

“Taxpayers are often the angel investors in pharmaceutical research and
development, yet this is not reflected in the prices they pay,” they wrote.
“The global community has anxiously awaited the results of remdesivir
clinical trials… However, an unaffordable drug is completely ineffective.
The substantial taxpayer investments in Covid-19 pharmaceutical research
must be recognized.”

The letter was sent following news that preliminary data from a study run
by the National Institute of Allergy and Infectious Diseases showed that
patients who received remdesivir recovered faster than similar patients who
received placebo. The results reported earlier this week were the first bit
of hopeful news since the pandemic began spreading around the globe, so far
claiming more than 222,000 lives.

On that basis, the Food and Drug Administration on Friday granted a
so-called emergency use authorization so that the intravenous drug can be
used to treat hospitalized patients with severe Covid-19. The move is
temporary, however, and is not a substitute for a formal product approval.
The U.S. government will coordinate the donation and distribution of
remdesivir to hospitals.

The buoyant reaction to the study, which pumped up Gilead stock, has been
accompanied, however, by growing wariness over future access to the
medicine. Broadly speaking, there is growing worldwide concern over the
affordability of any Covid-19 medical product, which prompted the World
Health Organization to consider a voluntary pool for collecting patents,
test data and other information.

In the U.S., such apprehension has increasingly emerged over medicines that
were discovered, in part, thanks to backing from the federal government.
And numerous consumer advocates, academics, and lawmakers have argued that
prescription drugs that were invented with taxpayer dollars should be
affordable to Americans.

Gilead, in fact, is at the center of such a battle right now. The drug
maker and the federal government have filed dueling lawsuits over patents
that formed the basis of a best-selling HIV prevention pill called Truvada.
The government claims Gilead should pay royalties on its patents, which
stemmed from taxpayer funding, while the company has argued the government
patents are invalid.

The legal struggle reflects the larger turmoil playing out over the rising
cost of medicines, a hot-button political issue that has, so far, stumped
the Trump administration and Congress. A growing number of Americans say
they are unable to afford their prescriptions. For years, though, Gilead,
in particular, has been in the crosshairs over high prices for its HIV and
hepatitis C pills.

Given its track record, the company is now facing scrutiny over its
intentions for remdesivir. Skepticism mounted after the company sought
orphan status for the drug, which came with a lucrative seven years of
marketing exclusivity. But the company asked the FDA last month to rescind
the designation amid criticism that orphan status would no longer apply for
a drug combating a pandemic.

Mindful of the flap, Gilead more recently agreed to donate 1.5 million
individual dosages of remdesivir that could be used for more than 140,000
patients. And Gilead chief executive officer Daniel O’Day, who joined the
company in early 2019, has repeatedly insisted in media interviews and in
remarks to Wall Street analysts that access will not be an issue.

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Nonetheless, questions remains about the extent to which remdesivir may
ever become a moneymaker for the company, which plans to spend about $1
billion on the drug. Despite intense global demand for the drug and
investor enthusiasm over study results, analysts have remained uncertain
whether the investment will yield a long-term return, especially after the
pandemic recedes.

“There is no rulebook out there, other than that we need to be very
thoughtful about how we can make sure we provide access of our medicines to
patients around the globe. And do that in a sustainable way for the company
for you as shareholders and we acknowledge that,” O’Day told analysts on
Thursday, according to a transcript of his remarks.

“We will be answering your questions on the sustainable model for
Remdesivir in the future, in the near future. We just don’t have the
answers yet… but we deeply respect and appreciate the fact that when we get
into millions of doses, we have to have a sustainable economic model that
works here and that achieves access to affordability to patients around the

About the Author

Ed Silverman

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.

 ed.silverman at statnews.com

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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