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 The coalition of more than 30 state attorneys general called on the
government to act or allow states to do so, saying in a letter to
U.S. health agencies that Gilead "has not established a reasonable
price" for remdesivir.
"Gilead should not profit from the pandemic and it should be pushed
to do more to help more people," the letter said.
The drugmaker is charging most U.S. patients $3,120 per course, or
$520 per vial of remdesivir.
Gilead said in a statement that the AGs were misrepresenting facts
about access to remdesivir and that the regulatory actions proposed
are unauthorized under these circumstances and would do nothing to
speed access.
The medicine is one of only two that have demonstrated an ability to
help hospitalized COVID-19 patients in formal clinical trials. It
received emergency use authorization (EUA) in the United States and
approval in other countries after it shortened hospital stays in a
large U.S. trial.
In the letter, the coalition, led by Louisiana Attorney General Jeff
Landry and California Attorney General Xavier Becerra, urged
RemdesivirFINALLetter202008041.pdf the federal government to
exercise its rights under the Bayh-Dole Act and license remdesivir
to third-party manufacturers to scale up production.
The letter went to the heads of the U.S. Health and Human Services (HHS)
department, the National Institutes of Health, and the Food and Drug
Administration.
Gilead and the health agencies did not immediately respond to
requests for comment.
The U.S. government, which provided some financial backing for the
drug's development, signed a deal with Gilead in June for more than
500,000 courses of the treatment, making up most of the company's
output through September.
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Gilead agreed to send nearly all of its remdesivir supply to the United States
between July and September, according to HHS. The agency and states are managing
allocation of the drug to U.S. hospitals over that period.
The government said it would receive around 94,000 treatment courses in July,
175,000 in August, and another 233,000 in September.
Still, the drug has been in scarce supply since the U.S. EUA in May, and
hospital staffers and politicians have complained about difficulties getting
access to it.
"Shipments are coordinated by the federal (government) and we have a bad
disconnect between what they think we need and what we really need," U.S.
Senator Marco Rubio of Florida tweeted last month, before announcing further
allocation to his hard-hit state.
Over the past four weeks, just under half of the U.S. remdesivir supply has gone
to COVID-19 hotspots Florida, Texas, California and Arizona.
Gilead has teamed up with generic drugmakers based in India and Pakistan,
including Cipla Ltd <CIPL.NS> and Hetero Labs Ltd, to make and supply remdesivir
in 127 developing countries. But only limited production has begun.
Last month, Cipla priced its generic version of remdesivir at $53.34 per 100
milligram vial, roughly one-tenth of the U.S. price.
Gilead shares were down 1.4% at $70.74.
(Reporting by Manojna Maddipatla in Bengaluru and Michael Erman in New York;
Editing by Lewis Krauskopf, Bill Berkrot and Simon Cameron-Moore)
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