Special status for coronavirus drug caught health officials off guard
When an experimental coronavirus treatment received a special designation from the Food and Drug Administration on Monday, it came as a surprise to the government's top health care officials — including the FDA commissioner.
Why it matters: Top officials aren't normally involved in everyday regulatory decisions. But this particular designation was particularly controversial, as critics quickly questioned whether it was giving an unfair financial advantage to one drugmaker in the midst of a pandemic.
Background: Pharmaceutical company Gilead Sciences is running clinical trials to test whether one of its drugs, called remdesivir, is an effective treatment against the novel coronavirus.
- On Monday, the FDA granted remdesivir status as an "orphan" drug.
- Orphan status is reserved for drugs that treat rare diseases. It gives their developers lucrative perks, such as an extended monopoly and tax credits, as an incentive to develop drugs that will only ever have a small market.
- At the time of the designation, fewer than 200,000 people had been diagnosed with the coronavirus in the U.S., which is the legal threshold for an orphan drug. But the virus is obviously spreading fast, and experts say it could eventually afflict a huge percentage of Americans.
The intrigue: Health and Human Services Secretary Alex Azar, FDA Commissioner Stephen Hahn and Janet Woodcock, who leads the FDA office in charge of new drugs, weren't aware ahead of time that remdesivir was receiving orphan status, according to multiple sources familiar with the situation.
- "It's unfathomable that the secretary and commissioner would be blindsided by their own agency on a major decision that was certain to be criticized. We're not going to find cures for a global pandemic such as COVID-19 by doling out exclusivity for one company and boxing out creative ideas," a senior HHS official told me.
The other side: "The FDA's initial orphan drug designation for remdesivir to treat COVID-19 was conducted in a similar manner as all determinations for this designation within the Office of Orphan Products Development and made based on standard legal and regulatory criteria," the FDA said in a statement.
Gilead said yesterday that it was asking the FDA to rescind the orphan designation.