Gilead Backs Down on Special Designation for Possible COVID-19 Drug
Pharmaceutical company had asked the FDA to designate remdesivir an 'orphan drug'
THURSDAY, March 26, 2020 (HealthDay News) -- Following severe criticism, Gilead Sciences is backing off special designation of its antiviral drug remdesivir -- which shows promise against COVID-19 -- that would have allowed the company to block competition and increase its profits for the drug.
Gilead asked the U.S. Food and Drug Administration to designate remdesivir a so-called orphan drug, saying COVID-19 qualified as a rare disease because fewer than 200,000 Americans are infected with it, and the FDA granted the request on Monday, the Associated Press reported.
The company was blasted for the move, and a letter sent to the company by more than 50 consumer and patient advocacy groups stated: "COVID-19 is anything but a rare disease." Millions of Americans are expected to eventually be infected with the coronavirus, the groups noted.
On Wednesday, Gilead asked the FDA to rescind the orphan drug designation for remdesivir, which was originally developed for Ebola and is undergoing tests as a treatment for COVID-19, the AP reported. Currently, there are no drugs, vaccines, or treatments approved in the United States for COVID-19. Some existing and experimental drugs are being assessed, and researchers are developing vaccines.