Statement of Peter Maybarduk, Director, Public Citizen’s Access to Medicines Program
Note: The U.S. Food and Drug Administration today granted experimental COVID-19 treatment remdesivir a special orphan status intended for drugs that treat rare diseases. The status sets up remdesivir’s manufacturer Gilead Sciences to receive additional federal tax credits in the United States and a bonus lucrative seven-year market exclusivity, allowing Gilead to exclude generic and more affordable competition while charging high monopoly prices, if the drug is approved.
Gilead’s pursuit of an orphan designation is unconscionable and could be deeply harmful. Remdesivir is one of relatively few medicines that may prove effective in treating COVID-19 this year. The government should be urgently concerned with its affordability for citizens. Instead, the FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and with it, the ability to charge outrageous prices to consumers.
Gilead has gamed the system by rushing through its “rare disease” orphan drug application while there are, for this brief moment, fewer than 200,000 COVID-19 U.S. cases. Its action is disingenuous and outrageous, and underscores the need for the federal government to step in.