The claim: Gilead Sciences received special protective status from the FDA for a drug that may effectively treat COVID-19
On Tuesday, the website Common Dreams published an article lambasting the Food and Drug Administration’s decision to provide pharmaceutical company Gilead Sciences “orphan” drug status for its antiviral drug remdesivir. The drug is among several potential treatments for the novel coronavirus.
The article relies heavily on a report in the Intercept, which reported on the story Monday night after the FDA approved special status for the drug that afternoon.
Common Dreams is a nonprofit website based in Portland, Maine. Its stories often aggregate reporting and commentary from prominent figures in progressive American politics. The site also frequently republishes state propaganda from leftist governments, especially Telesur, the Latin American news network with ties to the Cuban, Nicaraguan and Venezuelan governments.
Orphan drug status and Gilead’s antiviral treatment
Initially developed as a potential treatment for the Ebola and Marburg viruses, Gilead Sciences developed remdesivir alongside the Department of Defense, later deploying the drug during the 2014-16 Ebola epidemic in west Africa. The antirviral proved effective against a broad range of viruses, though it was not yet considered to be a perfect treatment for any specific disease.
Gilead had previously faced pressure to find ways to monetize antiviral drugs like remdesivir from investors prior to its application to the FDA, according to a separate report from The Intercept.
On Sunday, Gilead announced that it would stop allowing access to remdesivir for patients while it transitioned from providing individual compassionate use requests to an expanded access program.
"During this transition period, we are unable to accept new individual compassionate use requests due to an overwhelming demand over the last several days," the statement said.
On Monday afternoon, the FDA designated remdesivir as an “orphan” status drug.
"Orphan" drug status is a designation for medicines that treat conditions that would otherwise be unprofitable for companies to invest research and development resources in. The status provides certain government benefits, including exclusive rights to distribution, that ostensibly incentivize companies to address lesser-known diseases.
The FDA will provide orphan status to any medication that treats a disease that afflicts fewer than 200,000 people in the United States. However, the criteria for qualification says that approval “is defined as the number of persons in the United States who have been diagnosed as having the disease or condition at the time of the submission of the request for orphan-drug designation.”
At the time of Gilead’s submission to approve remdesivir for orphan status, there were fewer than 50,000 cases in the United States.
The drugmaker received significant criticism after it received approval for orphan drug status, including from Sanders. "We will not tolerate profiteering. Any treatment or vaccine must be made free for all," the senator and presidential candidate tweeted.
On Wednesday, Gilead issued another statement,saying that it had withdrawn its request for orphan status for remdesivir.
“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation,” it read.
Our ruling: True
The claim that pharmaceutical company Gilead Sciences requested and received approval for a special status for a potential COVID-19 treatment is TRUE based on our research.
While it is still unclear whether remdesivir is an effective antiviral treatment against the novel coronavirus, trials to determine that will now proceed without special FDA status for the drug.
- National Institute of Health, Remdesivir
- Food & Drug Administration, Orphan Drug Status
- eCFR, Designation of an Orphan Drug
- Gilead Sciences, Statement on Request to Rescind Remdesivir Orphan Drug Designation
- Gilead Sciences, Statement on Access to Remdesivir Outside of Clinical Trials
- Centers for Disease Control, Number of US Cases of COVID-19