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Photo: Budrul Chukrut/SOPA Images/LightRocket via 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.
  • 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.

Gilead said yesterday that it was asking the FDA to rescind the orphan designation.

Go deeper: Over 100 drugs are in testing in the race to treat coronavirus

Go deeper

33 mins ago - Health

Axios-Ipsos poll: America looks for the exits after a year of COVID

Data: Axios/Ipsos poll; Chart: Danielle Alberti/Axios

A year after the coronavirus abruptly shut down much of the country, Americans are watching for a clear signal of when the pandemic will be over — and most won't be ready to ditch the masks and social distancing until they get it, according to the latest installment of the Axios/Ipsos Coronavirus Index.

The big picture: The poll found that more Americans are expecting the outbreak to be over sooner rather than later, as vaccinations ramp up throughout the country — but that very few are ready to end the precautions that have upended their lives.

Caitlin Owens, author of Vitals
33 mins ago - Health

Many vulnerable Americans have received the coronavirus vaccine

Data: CDC, U.S. Census Bureau; Chart: Andrew Witherspoon/Axios

More than two-thirds of Americans 75 and older have received at least one dose of the coronavirus vaccine, as have more than half of those 65-74, per CDC data.

Why it matters: Any future surge in cases almost certainly wouldn't be as deadly as previous waves, because older people are the most likely to die from the virus.

3 hours ago - World

Report: "Clear evidence" China is committing genocide against Uyghurs

The scene in 2019 of a site believed to be a re-education camp where mostly Muslim ethnic minorities are detained, north of Kashgar in China's northwestern Xinjiang region. Photo: Greg Baker/AFP via Getty Images

Chinese authorities have breached "each and every act prohibited" under the UN Genocide Convention over the treatment of Uyghurs and other Muslim minorities in China's Xinjiang province, an independent report published Tuesday alleges.

Why it matters: D.C. think-tank the Newlines Institute for Strategy and Policy, which released the report, said in a statement the conclusions by dozens of experts in war crimes, human rights and international law are "clear and convincing": The ruling Chinese Communist Party bears responsibility.