Gilead Sciences asks FDA to rescind ‘orphan’ status for possible coronavirus treatment drug in rare move

"We are committed to making the medicine both accessible and affordable to governments and patients around the world."


After Gilead Sciences was granted Orphan Drug status for an experimental coronavirus drug, the pharmaceutical company asked the FDA to rescind the special regulatory status. Critics accused Gilead Sciences of manipulating a law that would allow the pharmaceutical company to profit exclusively off the drug.

The Orphan Drug status, which was an act passed in 1983, would give Gilead Sciences exclusive rights over their drug, remdesivir, limiting competitors from producing generic versions for seven years as well as qualifying for tax credits “meant to benefit companies which may not recoup their research costs after their drugs are put on the market.” But this drug status is “generally reserved for drugs that treat rare illnesses affecting fewer than 200,000 Americans.” Industry watchers said the number of patients that could be infected by coronavirus could possibly exceed 200,000.

“This is a wake up call,” Christopher Tang, a professor at the University of California, Los Angeles, who specializes in global supply chain management, said. “I fear these pharmaceutical companies would restrict the availability and jack up the price.”

Gilead Sciences quickly reversed course.

Remdesivir, a drug that may prove effective in treating COVID-19 this year, was first intended as a treatment for the Ebola virus. Currently, the drug has been given to five patients with mid- to late-stage infections in the United States, China and in other parts of Asia. With expected positive results from the studies, Gilead Sciences already began manufacturing the drug at a large cost to the company to prepare for huge demand, Biopharma Dive reported.

“We are committed to making the medicine both accessible and affordable to governments and patients around the world,” Gilead Sciences said in a statement.


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