Gilead Withdraws Request for Special Orphan Status on Experimental Coronavirus Treatment

Bowing to criticism that it was exploiting the coronavirus pandemic, the drugmaker Gilead said on Wednesday that it would no longer seek orphan-drug status for remdesivir, an experimental drug that is being tested as a possible treatment.

The Food and Drug Administration had only granted the special designation on Monday — which gives drug companies a seven-year monopoly on sales, tax credits and expedited approval. Gilead said it asked the agency to rescind the status.

The company’s decision to seek orphan status for the drug had drawn immediate criticism. Senator Bernie Sanders of Vermont, who is seeking the Democratic presidential nomination, called it “truly outrageous,” noting that Gilead had received “tens of millions” of dollars from the federal government to develop the drug.

The consumer group Public Citizen and other health groups sent a letter on Wednesday to Gilead’s chief executive, Daniel O’Day, asking him to reverse course. “This is an unconscionable abuse of a program designed to incentivize research and development of treatments for rare diseases,” the letter said. “Calling Covid-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.”

No treatment has been proved to be effective against Covid-19, the disease caused by the coronavirus, and Gilead is just one of several companies with drugs in trials around the world. More than 438,100 people have been sickened in at least 168 countries, according to official counts. As of Wednesday afternoon, at least 19,641 people had died.

The Orphan Drug Act, passed in 1983, was intended to encourage development of drugs that treat diseases

Keep reading this article on The New York Times Business.

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