Gilead Must Relinquish Monopoly on Potential Coronavirus Treatment

Gilead Sciences must immediately renounce its claim to a lucrative orphan drug designation for remdesivir - one of a few medicines being explored as a possible treatment for the coronavirus. That's what Public Citizen and 50 groups said in a letter sent today to Daniel O'Day, chairman and CEO of the pharmaceutical giant.

The orphan drug designation, which the U.S. Food and Drug Administration granted Gilead on Monday, will provide Gilead with seven years of marketing exclusivity - helping the company to shut out competitors and charge high monopoly prices. Gilead received this designation only by rushing to file its application while there were fewer than 200,000 known COVID-19 cases in the U.S. That is the population cap for eligibility as an orphan drug - one designed to treat rare diseases. Due to a lack of widely available testing, the number of cases likely already has surpassed that mark.

"This is an unconscionable abuse of a program designed to incentivize research and development of treatments for rare diseases," the letter reads. "COVID-19 is anything but a rare disease. Calling COVID-19 a rare disease mocks people's suffering and exploits a loophole in the law to profiteer off a deadly pandemic. Making the claim to special orphan status even more outrageous is the fact that the public already has largely paid for remdesivir's development through at least $60 million in grants and innumerable contributions from federal scientists. America, and the world, has the right to expect better from Gilead."

Gilead must reverse course and renounce its claim to orphan drug designation privileges for remdesivir, the groups insist.