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27 Mär 2020

USA: Gilead Sciences granted status to exclusively profit off of potential COVID-19 treatment; company requests govt. rescind designation after public outcry

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On 23 March 2020, the US Food and Drug Administration granted Gilead Sciences “orphan” drug status for its antiviral drug, remdesivir, which is being tested as a potential treatment for COVID-19. This status would allow the pharmaceutical company to profit exclusively for seven years from the product, raising public concerns about the affordability of this drug.

Following public outcry, on 25 March, Gilead Sciences issued a press release saying, "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. Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation."

Following this announcement Public Citizen called on Gilead Sciences to do more and commit to license the right and needed know-how to manufacture remdesivir to all qualified producers, in exchange for a modest royalty. We invited Gilead to respond; it did not.

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