Gilead Sciences, the company behind the potential COVID-19 treatment remdesivir, asked the U.S. Food and Drug Administration (FDA) to rescind the “orphan drug” status it gave remdesivir earlier this week. 

Gilead has submitted a request to the U.S. Food and Drug Administration [FDA] 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,” the statement reads. 

Remdesivir is an antiviral drug that is currently undergoing clinical trials as a potential treatment for COVID-19. There are currently six clinical trials occurring across the globe. 

The FDA’s orphan drug designation is a status given to drugs and biologics that are intended for “the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US,” according to the official webpage

The orphan program is aimed at financially incentivizing the development of the drug as well, and removes certain testing requirements, such as a pediatric study plan prior to filing a New Drug Application for FDA approval. Per NPR reporting, it also keeps generic versions of the medicine off the market longer, which would inevitably raise the price of the single version of the drug. 

Per the company statement, Gilead sought and was granted orphan drug status as the virus began to grow in the U.S. While there are currently more than 60,000 cases of coronavirus in the U.S., there are a total of 441,187 cases across the globe. Leading health officials anticipate that the case number stateside will continue to grow.

Due to this rapid growth, multiple organizations voiced disapproval over the company’s pursuit of the FDA’s orphan status, citing price-gouging concerns. Peter Maybarduk, the director of Public Citizen — a consumer rights advocacy group and think tank — said that Gilead’s seeking of orphan status “caused an immediate scandal,” and drove Public Citizens, as well as multiple other organizations, to author a letter asking President Trump to not allow monopolies on vaccines or treatments for COVID-19.

Maybarduk said that Gilead was “under great public pressure” to revoke the FDA’s orphan designation. He calls the biopharmaceutical company’s move to do so “a good first step.”

“We need Gilead to commit its patents, its know-how, and its data to the public domain so that others can build on the science,” he said. By doing so, generic medicines to treat the coronavirus can be made available for global benefit. 

Maybarduk also noted that AbbVie, another biopharma company, decided to not enforce patents on its HIV/AIDS drug Kaletra that is currently being tested for efficacy against coronavirus, setting a precedent for other drug companies to follow suit. 

“It’s about more than vague commitment to reasonable pricing,” Maybarduk continued, “it’s about affirmatively trying to help the public domain.”

In its statement, Gilead acknowledged this, saying: “Gilead recognizes the urgent public health needs posed by the COVID-19 pandemic. The company is working to advance the development of remdesivir as quickly as possible, and will provide updates as they become available.”

Gilead recently suspended its compassionate use access of remdesivir to patients with severe cases of coronavirus citing “overwhelming demand.” The company said it is focusing on processing previously approved requests of compassionate use and setting up a new system for handling requests.

Published on Mar 25, 2020