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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 13 mins ago - Energy & Environment

Thousands without power as "hazardous" winter storm lashes East Coast

Satellite imagery of the Northeastern U.S. taken by NOAA on Jan. 17. Photo: NOAA

A major winter storm lashed much of the East Coast Sunday and Monday, causing widespread power outages and disrupting travel over the holiday weekend.

The latest: Authorities in North Carolina confirmed that two people died in a car crash and that they responded 600 vehicle accidents during the storm on Sunday, per the Washington Post.

3 hours ago - Health

CDC director says COVID-19 messaging should have been clearer

Rochelle Walensky. Photo: Stefani Reynolds-Pool/Getty Images

Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in an interview with the Wall Street Journal that the messaging around the COVID-19 pandemic and changing guidance should have been clearer.

State of play: Walensky is being coached by media experts and is planning to have more press briefings by herself in order to ensure that CDC is seen as an independent, scientific entity, rather than as a political one, the Journal reports.

3 hours ago - World

UAE asks U.S. to reinstate Houthi terrorist designation after attack

Secretary of State Tony Blinken (left) listens to United Arab Emirates Foreign Minister Sheikh Abdullah bin Zayed al-Nahyan during a joint news conference at the State Department iin October. Photo: Andrew Harnik/Pool/AFP via Getty Images

Emirati Foreign Minister Abdullah Bin Zayed asked Secretary of State Tony Blinken in a phone call Monday to re-designate the Houthi rebels in Yemen as a terrorist organization, a senior Emirati official told Axios.

Why it matters: Less than a month after he assumed office, President Biden rolled back the Trump administration’s decision to make the designation. He said it hampered humanitarian assistance to the Yemeni people. Since then, the Houthis have escalated their attacks against Saudi Arabia and other countries in the region — including an attack Monday in Abu Dhabi.

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