President Trump and FDA Commissioner Stephen Hahn. Photo: Chip Somodevilla/Getty Images

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.

Go deeper

Updated 4 hours ago - Health

U.S. coronavirus updates

Data: The COVID Tracking Project; Map: Andrew Witherspoon/Axios

Florida is the new domestic epicenter of the coronavirus pandemic, and it's on track to keep getting worse.

Why it matters: Of the 20 U.S. metro areas with the highest daily case growth, nine are in Florida. The state health department announced 132 new deaths yesterday, the most the state has seen since the pandemic began.

Coronavirus leaves ICU beds in Arizona nearly full

A patient is taken from an ambulance to the emergency room of a hospital in the Navajo Nation town of Tuba City, Ariz. Photo: Mark Ralston/AFP via Getty Images

Coronavirus illness in Arizona has caused a new peak in hospitalizations and emergency room visits on Friday with intensive care units at 91% capacity, the Arizona Department of Health Services reports.

Why it matters: Nearly 25% of coronavirus tests in the state came back positive Thursday. Total hospitalizations in Arizona for COVID-19 surpassed 3,000 for the first time.

Jul 3, 2020 - Health

Fauci: Coronavirus surges mark a "very disturbing week" in the U.S.

Fauci testifies to the Senate Health, Education, Labor and Pensions Committee on June 30. Photo: Al Drago/AFP via Getty Images

NIAID director Anthony Fauci told medical journal JAMA on Thursday that it has been a "very disturbing week" for the spread of the novel coronavirus in the U.S.

What's happening: The number of coronavirus cases increased in the vast majority of states over the last week, and decreased in only two states plus the District of Columbia, Axios' Caitlin Owens reports.