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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

Senate confirms retired Gen. Lloyd Austin as defense secretary

Photo: Greg Nash-Pool/Getty Images

The Senate voted 93-2 on Friday to confirm retired Gen. Lloyd Austin as secretary of defense. Sens. Mike Lee (R-Utah) and Josh Hawley (R-Mo.) were the sole "no" votes.

Why it matters: Austin is the first Black American to lead the Pentagon and President Biden's second Cabinet nominee to be confirmed.

House will transmit article of impeachment to Senate on Monday, Schumer says

Photo: Drew Angerer/Getty Images

Senate Majority Leader Chuck Schumer (D-N.Y.) announced that the House will deliver the article of impeachment against former President Trump for "incitement of insurrection" on Monday.

Why it matters: The Senate is required to begin the impeachment trial at 1pm the day after the article is transmitted.

Dan Primack, author of Pro Rata
2 hours ago - Politics & Policy

Private equity bets on delayed tax reform in Biden administration

Illustration: Brendan Lynch/Axios

In normal times, private equity would be nervous about Democratic Party control of both the White House and Congress. But in pandemic-consumed 2021, the industry seems sanguine.

Driving the news: Industry executives and lobbyists paid very close attention to Treasury Secretary nominee Janet Yellen's confirmation hearings this week, and came away convinced that tax reform isn't on the near-term agenda.

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