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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.

Go deeper

Nov 29, 2020 - Health

New York City to reopen public schools with weekly testing

New York Mayor Bill de Blasio in New York on Nov. 28. Photo: Kena Betancur/AFP via Getty Images

Some New York City schools will be allowed to reopen for in-person learning as early as Dec. 7, Mayor Bill de Blasio announced Sunday.

The state of play: De Blasio said schools will no longer be forced to shutter when the city hits a 3% COVID-19 test positivity rate, but he did not specify what the new threshold will be. The school district will mandate weekly tests for 20% of children in each school, and students will not be tested before they return.

Nov 29, 2020 - Politics & Policy

Colorado governor and partner test positive for coronavirus

Colorado Gov. Jared Polis. Photo: Michael Ciaglo/Getty Images

Colorado Gov. Jared Polis (D) tweeted Saturday night that he and his partner, Marlon Reis, tested positive for COVID-19.

The big picture: He said they're both "asymptomatic, feeling well, and will continue to isolate at home." On Nov. 9, Polis extended a 30-day mask mandate to combat a rise in cases. The state has confirmed 225,283 coronavirus infections since the pandemic began. Since September, the governors of Wyoming, Nevada, Virginia and Missouri have also tested positive for the virus.

Nov 29, 2020 - Health

Fauci warns Thanksgiving travel will likely make COVID-19 surge worse

NIAID director Anthony Fauci warned on Sunday that the U.S. could see in the coming weeks "a surge superimposed upon that surge that we're already in," as COVID-19 cases are expected to rise after many Americans traveled for the Thanksgiving holiday.

Why it matters: Cases and hospitalizations are already skyrocketing nationwide. Governors and health departments in some states have warned that the increase in cases could overwhelm hospital systems.