Gilead Sciences Inc. is investigating the potential of remdesivir, a medicine it has been studying for years as part of its research in antivirals, as a treatment for patients with Covid-19. On March 23rd, the Food and Drug Administration (FDA) granted Gilead orphan drug status for remdesivir, a designation that gives a manufacturer a seven-year period of market exclusivity for the drug and tax credits on its research and development costs. After a public outcry, Gilead announced that it submitted a request to the FDA to rescind the orphan drug designation it had secured for remdesivir.
Consumer groups like Public Citizen had criticized Gilead for the designation. Public Citizen said in an open letter to Gilead’s CEO that the status, which aims to incentivize research and development for treatments for rare diseases, would have enabled Gilead to “exclude competitors and charge high monopoly prices.”
Following its request to rescind its orphan drug designation for remdesivir, Gilead’s CEO Daniel O’Day released a statement in which he said that the company will “work to ensure affordability and access” to the drug if it is approved “so that remdesivir is available to patients with the greatest need.”
Multiple clinical trials are underway to study the drug’s effects in Covid-19 patients. Initial results are on track to be reported in the coming weeks, according to O’Day.
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About Kristyn Fields
Kristyn Fields' practice is focused on antitrust litigation. Kristyn is a Senior Associate in the firm's New York office.Prior to joining F&F, Kristyn interned for the Honorable Martin Marcus, New York Supreme Court, Bronx County. As well, Kristyn participated in the Brooklyn Law Incubator & Policy Clinic providing pro bono counsel to emerging start-up companies. While at Brooklyn Law School, Kristyn served as an Executive Articles Editor of the Brooklyn Journal of Corporate, Financial & Commercial Law. Also, Kristyn was a member of the Moot Court Honor Society.Kristyn earned her J.D. from Brooklyn Law School (2016). Kristyn earned her undergraduate degree from Boston College (B.A., Political Science, 2013).Kristyn is licensed to practice law in New York.