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Breaking down the tug of war over the FDA and convalescent plasma

A big story that slipped under the radar during last night's RNC: The FDA commissioner apologized for overselling the benefits of convalescent plasma for treating the coronavirus.

Why it matters: The FDA is supposed to be a Switzerland of neutrality within government, able to act based on science instead of pressure from politicians and big business.


  • "I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," said FDA Commissioner Stephen Hahn.

The big picture: The Trump administration has publicly pressured the FDA on granting an emergency use authorization for plasma.

  • President Trump and trade adviser Peter Navarro have privately and publicly criticized the FDA for holding up authorization, accusing staffers of being part of the "deep state."
  • Trump said plasma "has proven to reduce mortality by 35%" in a Sunday press conference.
  • Hahn echoed Trump's comments, which he apologized for last night, saying what he "should have said better is that the data show a relative risk reduction not an absolute risk reduction."

Between the lines: Public health leaders made a public outcry against quick approval of the treatment.

  • That includes top NIH scientists Francis Collins, Anthony Fauci and H. Clifford Lane.
  • “The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the New York Times.
  • Hahn said yesterday that the final decision "was made by FDA career scientists based on data submitted a few weeks ago."

The bottom line: Hahn's predecessor Scott Gottlieb tweeted: "I am confident in the science part of the evaluation executed by CBER. The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you loose [sic] it in buckets."

Louisville police declare state of emergency as Breonna Taylor decision looms

The Louisville Metro Police Department (LMPD) declared in a memo obtained by news outlets a "state of emergency" on Monday to prepare for Kentucky Attorney General Daniel Cameron's expected announcement on the Breonna Taylor case.

Of note: Louisville has witnessed more than 115 days of protests over the police killing of Taylor, an unarmed Black woman, with calls for all the officers involved to be charged.

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Sen. Cory Gardner on vacant Supreme Court seat: "I will vote to confirm"

Sen. Cory Gardner (R-Colo.) will vote to confirm President Trump's nominee to replace the late Ruth Bader Ginsburg, he announced in a statement Monday.

Why it matters: The development is a win for President Trump and Senate Majority Leader Mitch McConnell (R-Ky.). It should mean Republicans are all but assured to have enough support to hold hearings for Trump's potential nominee.

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Trump and Xi to give dueling speeches Tuesday at UN General Assembly

President Trump and China’s Xi Jinping will address the UN General Assembly just minutes apart on Tuesday morning — with Russia’s Vladimir Putin following soon thereafter.

The big picture: Trump has promised a “strong message on China.” Xi, meanwhile, is expected to laud global cooperation — with the clear implication that it can be led from Beijing.

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Trump meets with Supreme Court frontrunner Amy Coney Barrett

President Trump met with Judge Amy Coney Barrett Monday afternoon at the White House, days before he is set to announce his pick to fill the Supreme Court seat vacated by Justice Ruth Bader Ginsberg, two sources familiar with meeting tell Axios.

Between the lines: Barrett, a U.S. circuit court judge who has long been seen within Trumpworld as the frontrunner on the president's short list, is known widely within the White House and well-liked.

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Federal judge extends deadline for Wisconsin ballots postmarked by Election Day

A federal judge in Wisconsin on Monday extended the state's deadline for counting absentee ballots until up to six days after the Nov. 3 election if they are postmarked by Election Day, AP reports.

Why it matters: The ruling, unless overturned, "means that the outcome of the presidential race in Wisconsin likely will not be known for days after polls close," according to AP.

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Trump's Supreme Court plans create major opportunity for Kamala Harris to go on offense

President Trump's Supreme Court plans have created a major opportunity for Sen. Kamala Harris to go on offense.

Why it matters: A confirmation fight puts Harris back in the spotlight thanks to her role on the Senate Judiciary Committee.

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McConnell: Senate has "more than sufficient time" to process Supreme Court nomination

Senate Majority Leader Mitch McConnell (R-Ky.) said in a floor speech Monday that the chamber has "more than sufficient time" to confirm a replacement for Supreme Court Justice Ruth Bader Ginsburg before the election, and accused Democrats of preparing "an even more appalling sequel" to the fight over Brett Kavanaugh's confirmation.

Why it matters: Senate Minority Leader Chuck Schumer (D-N.Y.) has said "nothing is off the table next year" if Republicans push ahead with the confirmation vote before November, vowing alongside Rep. Alexandria Ocasio-Cortez (D-N.Y.) to use "every procedural tool available to us to ensure that we buy ourselves the time necessary."

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House Democrats file legislation to fund government through Dec. 11

House Democrats on Monday released their proposal for short-term legislation to fund the government through December 11.

Why it matters: This is Congress' chief legislative focus before the election. They must pass a continuing resolution (CR) before midnight on Oct. 1 to avoid a government shutdown — something both Hill leaders and the White House have claimed is off the table.

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