President Trump at the White House on Aug 20. Photo: Jabin Botsford/The Washington Post via Getty Images

President Trump on Saturday baselessly accused the Food and Drug Administration — which he likened to the "deep state, or whoever" — of making it harder for drug companies to distribute coronavirus treatments and vaccines.

Why it matters: Trump's tweet comes on the heels of a policy change by the Department of Health and Human Services to block the FDA's ability to regulate lab-developed tests, including for the coronavirus — which has public health experts worried that unreliable COVID-19 tests could go to market.

Where it stands: The FDA has authorized 218 coronavirus tests with emergency use authorizations as of Friday, which includes 176 molecular tests, 39 antibody tests, and 3 antigen tests, the agency said.

  • Philip Dormitzer, Pfizer’s head of vaccine research, told Bloomberg on Friday that trials are "going very quickly."

What they're saying: "For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for Covid," former FDA Commissioner Scott Gottlieb, who served under Trump, tweeted roughly an hour after the president on Saturday morning.

  • But, Gottlieb noted that the "FDA might not be able to provide critical advice to test developers or take needed enforcement actions against bad tests" since the HHS took the reins this week.
  • "We'll see a plethora of DTC Covid tests enter the market, where tests ship directly to consumers and are processed in a central lab operating outside FDA oversight," Gottlieb said.
  • House Speaker Nancy Pelosi called Trump's tweet "a very dangerous statement" at her Saturday press briefing and said that "even for him, it went beyond the pale."

Between the lines: The policy change surprised many at the FDA and "was a point of intense disagreement" between FDA Commissioner Stephen Hahn and HHS Secretary Alex Azar, the Washington Post reports. Hahn opposed the change.

The other side: Supporters said the change, announced Wednesday, could allow innovative tests to reach the public more efficiently, and countered that the FDA's process slowed testing at the start of the pandemic, per the Post.

  • “This deregulatory action ensures compliance with law, is responsive to multiple Trump Administration Executive Orders, is a key lesson learned, and better prepares us for future pandemics," HHS chief of staff Brian Harrison said in an emailed statement.
  • “It is false to say that this will lead to unregulated, low quality COVID-19 tests," HHS general counsel Robert Charrow emailed.

The FDA did not respond to a request for comment. The White House declined to comment.

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Illustration: Aïda Amer/Axios

  1. Global: Total confirmed cases as of 12 a.m. ET: 33,282,969 — Total deaths: 1,000,867 — Total recoveries: 23,066,203Map.
  2. U.S.: Total confirmed cases as of 12 a.m. ET: 7,148,009 — Total deaths: 205,069 — Total recoveries: 2,794,608 — Total tests: 102,342,416Map.
  3. Business: Companies are still holding back earnings guidance.
  4. Health: Trump announces plan to distribute 150 million rapid tests —The childless vaccine.
  5. Media: Fauci: Some of what Fox News reports about COVID-19 is "outlandish"
  6. States: Cuomo extends New York moratorium on evictions until 2021.
  7. World: More than 1 million people have now died from coronavirus — India the second country after U.S. to hit 6 million cases.
Updated 22 hours ago - Health

World coronavirus updates

Expand chart
Data: The Center for Systems Science and Engineering at Johns Hopkins; Map: Axios Visuals

India became on Monday the second country after the U.S. to surpass 6 million cases.

By the numbers: Globally, nearly 997,800 people have died from COVID-19 and over 33 million have tested positive, Johns Hopkins data shows.

Updated Sep 27, 2020 - Health

3 states set single-day coronavirus case records last week

Data: Compiled by Axios; Map: Danielle Alberti/Axios

Utah, North Carolina and Wyoming set new highs last week for coronavirus infections recorded in a single day, according to the COVID Tracking Project (CTP) and state health departments. Utah and Wyoming surpassed records set the previous week.

Why it matters: Record case highs have usually meant that more hospitalizations and other serious outcomes are on the way, CTP's latest weekly update notes.