August 7, 2020
LANSING – Michigan Attorney General Dana Nessel has joined a bipartisan coalition in sending a letter request to the U.S. Health and Human Services (HHS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA), urging them to use their legal authority under the Bayh-Dole Act to increase the availability of the prescription drug, remdesivir. Remdesivir, a drug manufactured by Gilead Sciences Inc. (Gilead), has shown promising results in reducing mortality and hospitalization from COVID-19.
Remdesivir is an FDA fast-tracked antiviral drug that was produced with the benefit of millions of dollars of federal funding and the time and expertise of CDC and military scientists. Despite the substantial federal funding provided to its manufacturer, Gilead has been unable to assure a supply of remdesivir sufficient to alleviate the health and safety needs of the country amid the pandemic.
"Mounting scientific data is showing that remdesivir can benefit those battling COVID-19, and the federal government should want to do everything in its power to ensure it is accessible to all who need it," said Nessel. "My colleagues and I are urging these agencies to use their legal authority to guarantee widespread access to this prescription drug, and make certain that it is not only available to those with deep pockets or political connections, but everyone whose health is strained by this pandemic. This nation and the entire world is in the middle of a crisis and if the federal government isn't going to exercise its authority to address the current and unconscionable $3,200 price tag Gilead has set per treatment course, then we ask them to assign such authority to the states."
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As of Aug. 3, 2020, more than 4.64 million Americans have contracted COVID-19 and 154,000 have died. Yet, by the end of this year, Gilead is expected to produce only two million treatments, or enough remdesivir to cover about half of the current confirmed COVID-19 patients in the U.S. Before this crisis is over and a vaccine is made available, many more Americans may become sick, and their recovery may hinge on the availability and affordability of remdesivir.
In Tuesday's letter, the bipartisan coalition urges the federal government to exercise its rights under the Bayh-Dole Act, which allows the NIH and FDA to ensure Americans can afford and have reasonable access to a sufficient supply of remdesivir during this pandemic. Despite a manufacturing cost of between $1 and $5, Gilead has set the price of the drug at an outrageous and unconscionable $3,200 per treatment course. Under the Bayh-Dole Act, the NIH and FDA has the authority to license remdesivir to third-party manufacturers to scale up production and distribution and ensure the drug is made available to all those in need at a reasonable price. If these agencies are unwilling to exercise this authority, the states request that the agencies assign this authority for the states to use. The bipartisan coalition stands ready to ensure that drug manufacturers are licensed to meet market demand during this public health crisis.
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Nessel joins the attorneys general of Alaska, American Samoa, California, Connecticut, Delaware, the District of Columbia, Guam, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, 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 in sending this letter.
A copy of the letter is available here.
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