[President Biden’s NIH rejects a petition to seize the patent of
an unaffordable prescription drug.]
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A BIG MISS ON DRUG PRICES  
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David Dayen
March 22, 2023
The American Prospect
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_ President Biden’s NIH rejects a petition to seize the patent of
an unaffordable prescription drug. _

The Department of Health and Human Services and the National
Institutes of Health have rejected a petition from prostate cancer
patients to seize the patents of the high-cost drug Xtandi., Evan
Vucci / AP Photo

 

The Biden administration has seen firsthand in the past few weeks the
benefits of using statutory power to bring down prescription drug
costs. With Novo Nordisk
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the lead of Eli Lilly and announcing their intent to slash the list
price of their insulin medications by 65 percent or more, practically
all diabetes patients will see relief, mostly thanks to a change in
Medicaid rebates
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into the American Rescue Plan. It upended the usual laissez-faire
attitude about prescription price-gouging, and showed that the
government, as a major medication buyer, can intervene to lower costs.

Which is why it’s so disappointing that a separate effort to take
action on an even wider array of pharmaceuticals has fizzled. The
Department of Health and Human Services (HHS) and the National
Institutes of Health (NIH) have rejected a petition
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prostate cancer patients to use a provision of the Bayh-Dole Act of
1980 to seize the patents of a high-cost drug because of its high
price.

The tactic, known as “march-in rights,” was a core pillar of
the Day One Agenda
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The Bayh-Dole Act specifies how the government awards patents to drugs
developed with publicly funded research (a significant number). But if
the feds find that the drug is not being made accessible on
“reasonable terms,” they can march in and extinguish the patent,
allowing generic competitors to market their own versions.

_MORE FROM DAVID DAYEN_ [[link removed]]

But march-in rights have never been used
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inception, and NIH has repeatedly rejected the idea that affordability
is a reasonable term. Advocates thought they found the perfect test
case
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a new administration that paid lip service to lowering prescription
drug costs: a cancer drug called Xtandi (enzalutamide), which lists at
an average wholesale price in the U.S. of $188,900 per year
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range as high as $10,000 or more.

This is three to six times the list price of Xtandi in every other
industrialized country in the world. Grants from the NIH and the U.S.
Army helped create Xtandi, which is owned by a Japanese pharmaceutical
conglomerate named Astellas (Pfizer co-owns the U.S. market for the
drug). An FDA-approved generic is ready and waiting whenever the
monopoly patent expires. Patent holders have already made back $20
billion in revenue on the drug, far beyond their costs.

But NIH, in a letter sent late Tuesday
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rejected march-in for Xtandi for the second time, the other coming in
2016. Xtandi is “widely available to the public on the market,”
acting NIH director Lawrence Tabak wrote, and march-in would not be
“an effective means of lowering the price of the drug.” This
effectively rejects the idea that price is an important component of
access; in fact, the letter edits out “reasonable terms” as the
condition of drug availability under Bayh-Dole.

The outcry was immediate. “What the Biden Administration is saying
is that charging US residents 3 to 6 times more than any other
high-income country is reasonable,” wrote Knowledge Ecology
International, which has taken the lead on march-in challenges. The
decision “protects monopolists over taxpayers and patients, despite
clear statutory authority and reasonableness to intervene,” said
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Lloyd Doggett (D-TX), who had urged the NIH
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act. “How many prostate cancer patients will die because they cannot
afford this unacceptable price?” asked
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Bernie Sanders (I-VT).

The leadership of the NIH has been historically unwilling to disrupt a
lucrative gravy train for themselves and their research partners. Some
senior NIH officials receive personal royalties
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year for prescription drugs and other treatments. The old Upton
Sinclair line
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it being difficult to get a man to understand something when their
salary depends on not understanding it applies here.

That pharma lobbyists get this big win right at the time when the
administration has demonstrated the ability to force insulin prices
lower is perhaps the biggest disappointment. Separately, the
government is today breaking up a monopoly nonprofit
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controls the organ transplant system, a glimmer of hope to reduce the
extreme backlog for transplants. NIH and HHS could have stopped a
similar racket that protects monopoly patents for drugs that U.S.
taxpayers paid to develop. But they’re clearly too implicated in the
system to overhaul it.

_DAVID DAYEN is the executive editor of The American Prospect. He is
the author of Monopolized: Life in the Age of Corporate Power (2020)
and Chain of Title: How Three Ordinary Americans Uncovered Wall
Street’s Great Foreclosure Fraud (2016), which earned the Studs and
Ida Terkel Prize. He was the winner of the 2021 Hillman Prize for
excellence in magazine journalism._

_Become A Member [[link removed]] of THE AMERICAN
PROSPECT. Pledge to support fearlessly independent journalism by
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* prescription drugs
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* profits
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* patents
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* National Institutes of Health
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* Department of Health and Human Services
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