Attorney General Mark R. Herring joined a bipartisan coalition of 34 state attorneys general in sending a letter to 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 remdesivir. Remdesivir, a drug manufactured by Gilead Sciences, Inc. (Gilead), has shown promising results in reducing mortality and hospitalization from COVID-19.
“We continue to be in the middle of an unprecedented public health crisis, and it is so important that any proven medication that can help individuals hospitalized with COVID-19 is readily available and accessible,” said Herring. “The Trump Administration should make every possible effort to aid COVID-19 patients in their recovery and prevent more deaths and that includes making drugs that have proven promising available and affordable.”
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.
As of August 3, 2020, more than 4.64 million Americans have contracted COVID-19 and more than 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 made available, many more Americans may become sick, and their recovery may hinge on the availability and affordability of remdesivir.
In the 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.
Joining Herring are the attorneys general of Alaska, American Samoa, California, Connecticut, Delaware, Guam, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, 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, Washington, and the District of Columbia.