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25 Mär 2020

Sharon Lerner, The Intercept

Gilead Sciences backs off monopoly claim for promising coronavirus drug

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[T]he FDA had awarded Gilead seven years of exclusive marketing rights to the drug through the Orphan Drug Act, even though the statute was designed to induce pharmaceutical companies to make treatments for rare diseases that affect fewer than 200,000 people in the United States... Although the new coronavirus will almost certainly infect that many people, Gilead had exploited a loophole that grants orphan drug status if a company files for it before the official number of cases hits 200,000.

... After a public outcry, Gilead issued a press release stating: Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of Covid-19 and is waiving all benefits that accompany the designation... [P]ublic health experts remain concerned about the potential for Gilead and other pharmaceutical companies to engage in price gouging during the global pandemic... Gilead, which is valued at more than $100 billion, has repeatedly come under fire for its pricing.

... When asked about price gouging, Gilead [said]: "Gilead is acutely aware of the urgent medical needs of people and communities around the world in the face of the Covid-19 pandemic. We are working around the clock to study the safety and efficacy of remdesivir as a potential Covid-19 treatment and to responsibly provide emergency access to remdesivir while these studies are ongoing, to respond to this public health crisis. If remdesivir is proven to be safe and effective to treat Covid-19, we are committed to making remdesivir both accessible and affordable to governments and patients around the world."