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Pharma Giant Gilead Retracts Request FDA Extend Monopoly Status on Experimental Covid-19 Drug

Mar 26, 2020. 12 comments

Pharmaceutical giant Gilead Sciences on Wednesday retracted its effort to score extended monopoly rights and tax breaks on its antiviral drug remdesivir, which scientists are evaluating as a possible treatment in the novel coronavirus pandemic.

Per the Intercept, on Monday the Food and Drug Administration awarded Gilead “orphan” drug status for remdesivir, which would give it a marketing monopoly on the drug for seven years rather rather than the more typical five, blocking rivals from introducing lower cost versions of it. It would also accelerate FDA approval of the drug and entitle Gilead to grants and tax credits amounting to 25 percent of the cost of clinical drug testing. As the Intercept noted, this status is supposed to encourage development of drugs for rare diseases and is limited to drugs for ailments that affect less than 200,000 people in the country or where the manufacturer is not expected to recoup costs. But it has become one of the vehicles by which pharmaceutical companies are able to extend exclusivity periods and maintain high pricing.

Gilead was able to claim the status because, despite projections showing the virus is likely to infect many times that number, at the time of its application there were far fewer cases. According to the Intercept, remdesivir was developed with at least $79 million in federal funding, while Bank of America analysts projected Gilead would make up to $2.5 billion in one-time revenue. Gilead claimed it had only applied for orphan drug status to expedite remdesivir’s approval, but the FDA’s approval faced swift political backlash from Vermont Senator Bernie Sanders and a coalition of 50 groups organized by Public Citizen.

On Wednesday, Gilead formally asked the FDA to retract the orphan drug status and told the New York Times in a statement that it was now confident the FDA would pursue a speedy approval regardless. The FDA has agreed to the request, per Reuters.

As Stat noted, former Gilead executive Joseph Grogan is on the White House’s coronavirus task force, and Gilead filed for the status in early March, when it would have been well aware that the disease was likely to grow beyond the 200,000 person cap.

“Gilead folded,” Knowledge Ecology International head Jamie Love told Stat. “It was already known that Covid-19 was spreading in the U.S. and the CDC was warning it could be a pandemic.

Remdesivir, along with hydroxychloroquine and chloroquine, is one of the drugs Donald Trump claimed could accelerate efforts to handle the pandemic in the U.S., which now has over 68,350 confirmed cases of the coronavirus. It’s previously shown effectiveness in limiting mortality from the Ebola virus. While early signs were promising , remdesivir’s efficacy in treating the virus has yet to be proven. National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci has sought to temper expectations on how well known drugs will perform. 

The drug is one of several being looked at in a major World Health Organization study . Earlier this week, Gilead halted distribution of the drug under an emergency access program to start large-scale trials that have not yet begun, catching some patients and doctors off guard.

“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 wrote in the statement. “Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of covid-19 are being expedited.”

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