Gilead asks FDA to rescind its Orphan Drug status for potential coronavirus treatment following criticism

pharmafile | March 26, 2020 | News story | Business Services China, Gilead, Wuhan Coronavirus, china coronavirus, coronavirus 

Gilead Sciences has submitted a request for the FDA to rescind its offer of Orphan Drug designation for remdesivir in treating coronavirus, after a huge public backlash.

Orphan Drug designation allows a company to profit of their drug exclusively for seven years and it also blocks other companies from developing generic versions of the product. The Orphan Drug Act in 1983, which made this law, was originally designed to ensure that companies would develop drugs for rare diseases and the exclusivity helps them recoup their research costs when the drug goes to market.

The Intercept outlined how Gilead was given this designation despite the drug being developed with $79 million from the US government.

This prompted a backlash from activists and politicians. Presidential candidate, Senator Bernie Sanders tweeted that: “It is insane and unacceptable that the Trump Administration has given the Gilead pharmaceutical corporation a seven-year monopoly on a potential coronavirus treatment. We will not tolerate profiteering. Any treatment or vaccine must be made free for all.”

The decision by the FDA was also criticised by Peter Maybarduk, the Director of Public Citizen’s Access to Medicines Program, who said: “Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year. The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and, with it, the ability to charge outrageous prices to consumers.

“Gilead has gamed the system by rushing through its ‘rare disease’ orphan drug application.”

In addition to Gilead responding to the backlash by asking for the FDA to rescind their Orphan status, they are also waiving all benefits that accompany this designation. They say they are confident that they can maintain a quick timeline in getting a standard FDA approval and review of remdesivir for the treatment of COVID-19.

Remdesivir is a drug that has previously been studied as a treatment for Ebola and previous coronaviruses SARS and MERS. It is currently in two late-stage trials for COVID-19.

Conor Kavanagh

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