TOPEKA – (August 4, 2020) – Kansas Attorney General Derek Schmidt today urged federal agencies to exercise special legal authority to increase the availability of remdesivir, a drug showing results in reducing hospitalization and mortality from COVID-19.
Schmidt, along with a bipartisan coalition of 33 other state and territory attorneys general, requested the U.S. Department of Health and Human Services, National Institutes of Health and Food and Drug Administration use their authority under a 40-year-old federal statute to prevent manufacturing bottlenecks and ensure that Americans can afford the drug and have reasonable access to a sufficient supply. The statute was enacted in 1980 through legislation sponsored by then-U.S. Senator Bob Dole.
Remdesivir, manufactured by Gilead Sciences, Inc., 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 the Centers for Disease Control 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.
“We are in unsettled times, and Americans must be assured of meaningful access to remedies that can save lives,” Schmidt said.
Despite a manufacturing cost of between $1 and $5, Gilead has set the price of the drug at $3,200 per treatment course and has been unable to provide assurances it can produce enough of the medication to meet demand. In today’s letter, the bipartisan coalition of attorneys general urged 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. One provision of the statute authorizes the NIH and FDA to license remdesivir to third-party manufacturers in order to scale up production and distribution to ensure the drug is made available to all those in need at a reasonable price.
The Bayh-Dole Act, which became law in 1980, was designed to improve research and development at universities and other entities. The act is named for senators Bob Dole, a Kansas Republican, and Birch Byah, an Indiana Democrat. The intent was to encourage innovation and economic development through federal funding, and the granting of patents and licenses related to intellectual property.
A copy of the letter can be found https://bit.ly/3i1WYYk.