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State attorneys general: Use federal law to lower cost, increase supply of COVID-19 drug remdesivir

USA TODAY logo USA TODAY 8/4/2020 Ken Alltucker, USA TODAY
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A bipartisan coalition of attorneys general asked the U.S. Department of Health and Human Services on Tuesday to invoke a federal patent law to increase supply and lower prices of the COVID-19 drug remdesivir.

The group, led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry, said HHS, the Food and Drug Administration and National Institutes of Health should license Gilead Sciences’ antiviral to other manufacturers to ease potential shortages and lower the drug's price.

Gilead charges $3,120 for a five-day course for patients with private insurance, Medicare or Medicaid. Remdesivir supplies are "dangerously limited," and the price will "impede access to treatment" and strain state budgets, the attorneys general wrote in a letter to the federal agencies.

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The 1980 Bayh-Dole Act allows federal agencies to retain patent rights if a drug company charges too much or fails to reasonably “alleviate health or safety needs” of consumers, the letter says. If federal agencies refuse the request, the group wants "march-in" rights to be assigned to states.

"We cannot afford to leave the supply of this critical medication to chance and the whims of the marketplace when it was funded in part by taxpayer dollars," said Becerra, a Democrat.

Landry, a Republican, said Gilead's pricing is not reasonable and the drug company has not met the public's health and safety needs. 

"Our bipartisan coalition is calling on the federal government to exercise its rights to help increase the supply of remdesivir and lower its price," he said.

The letter is signed by attorneys general of 31 states: California, Louisiana, Alaska, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, Virginia and Washington. Attorneys general for the District of Columbia, American Samoa and Guam also signed. 

The nonprofit Institute for Clinical and Economic Review suggested remdesivir should be priced from $2,520 to $2,800 per course. The price takes into account the benefit of the inexpensive steroid dexamethasone, which showed in an early study to be a lifesaving treatment for seriously ill COVID-19 patients.

Remedsivir, an antiviral developed to treat Ebola, benefited from public funding, including a $30 million NIH-funded clinical trial this year, the letter says.

Gilead plans to make 2 million treatment courses available by the end of this year, which the attorneys general said isn't enough to meet the needs of the nation's coronavirus patients.  As of Tuesday, more than 4.7 million Americans have been diagnosed with COVID-19, and almost 156,000 have died, according to Johns Hopkins University.

Under the Emergency Use Authorization (EUA), remdesivir is only indicated for use by hospitalized patients with severe COVID-19. Remdesivir additionally must be administered by intravenous infusion.

In a statement, Gilead disputed the attorneys general claim there won't be enough remdesivir. Many COVID-19 patients don't need the drug because they have mild or no symptoms and recover without a hospital trip.

"Gilead is investing more than $1 billion this year to expand its manufacturing capacity for remdesivir, including bringing on board numerous manufacturing partners around the world, and plans to invest significantly more in 2021, if needed," the company said. "This will enable Gilead to manufacture two million courses of therapy this year to meet and exceed actual projected patient demand for remdesivir."

Gilead said using "march-in" rights to get another manufacturer won't add more doses this year because the drug takes six to 12 months to make. And such a move would discourage other drug companies from investing in new therapies and vaccines. 

A study in JAMA Internal Medicine estimated COVID-19 cases ranged from six to 24 times higher than official counts. The large federal study relied on antibody testing data in 10 cities to gauge whether individuals previously were infected with SARS-CoV-2, the virus that causes COVID-19. Antibody tests are different from diagnostic tests, which detect whether someone is currently infected. 

In July, Gilead said a late-stage clinical trial of nearly 400 patients showed 74% of patients given remdesivir recovered by their 14th day of hospitalization compared with 59% of those who did not get the drug. Patients who received remdesivir had lower mortality rates than patients who did not get the drug.

This article originally appeared on USA TODAY: State attorneys general: Use federal law to lower cost, increase supply of COVID-19 drug remdesivir


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