Today in one sentence: The FDA "grossly misrepresented data" about the use of blood plasma therapy to treat coronavirus patients; the FDA Commissioner apologized for overstating the benefits of treating COVID-19 patients with plasma; the FDA Commissioner pushed back against Trump's baseless claim that the "deep state" is deliberately stalling coronavirus vaccine development at the FDA; New York and New Jersey sued Trump and Postmaster General Louis DeJoy over changes to postal service operations; and the House Foreign Affairs Committee's subpanel on oversight is investigating Mike Pompeo’s decision to speak at the Republican National Convention.



1/ The FDA “grossly misrepresented data” about the use of blood plasma therapy to treat coronavirus patients, according to the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. Trump, Dr. Stephen Hahn, the commissioner of the Food and Drug Administration, and Alex Azar, the health and human services secretary, announced the emergency approval of convalescent plasma, claiming that it would reduce coronavirus deaths by 35% this year. Experts and scientists, however, say the way the administration framed the data is misleading and don’t know exactly where the statistic came from. The data may have been calculated based on a small subgroup of hospitalized COVID-19 patients in a Mayo Clinic study, but does not appear in the official authorization letter issued by the FDA, nor was it in a memo written by FDA scientists. (New York Times)

2/ FDA Commissioner Stephen Hahn apologized for overstating the benefits of treating COVID-19 patients with convalescent plasma. While the therapy is considered safe, plasma has not yet been proven effective against the coronavirus. Hahn did not dispute Trump’s assessment that plasma is a “very effective” treatment at a news conference, but distorted the findings from a Mayo Clinic study when he said “if you are one of those 35 out of 100 people who these data suggest survive as a result of it, this is pretty significant.” Hahn later conceded scientists found that patients given plasma early in their illness fared better than those who received it later. The Mayo study, however, lacked a control group. (Politico / Associated Press / Bloomberg / CNBC)

3/ Stephen Hahn pushed back against Trump’s baseless claim that the “deep state” is deliberately stalling coronavirus vaccine development at the FDA. “I have not seen anything that I would consider to be ‘deep state’ at the FDA,” Hahn said in response to Trump’s accusation that people working at the FDA are intentionally complicating efforts to test COVID-19 vaccines in order to delay the results until after the November election. Despite Trump’s attacks, Hahn says he still has “a very good relationship with the president” and that he feels “very comfortable and continue to feel comfortable with that relationship.” (Reuters / The Hill)

4/ Dr. Anthony Fauci warned against an emergency use authorization for a coronavirus vaccine until it’s proven safe and effective. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” Fauci said. Health experts say they’re worried that the White House may pressure the FDA to push out a vaccine under an emergency use authorization before it has been fully tested. Fauci also declined to comment on Trump’s recent tweets about the “deep state” and the FDA, but he reiterated the risks of rushing vaccine development “before you have a signal of efficacy.” (Reuters)

5/ New York and New Jersey sued Trump and Postmaster General Louis DeJoy over changes to postal service operations. The lawsuit asks the court to vacate recent changes, including the removal of mailboxes and mail sorting machines, and curtailing of overtime, made to the U.S. Postal Service and to stop it from implementing additional service reductions at a time when a pandemic has prompted millions more people than usual to plan to vote by mail. New York Attorney General Letitia James said in a statement: “This USPS slowdown is nothing more than a voter suppression tactic […] these authoritarian actions are not only jeopardizing our democracy and fundamental right to vote, but the immediate health and financial well-being of Americans across the nation.” (Bloomberg / Reuters)

6/ The House Foreign Affairs Committee’s subpanel on oversight is investigating Mike Pompeo’s decision to speak at the Republican National Convention. Pompeo’s choice to speak at the convention “may violate the Hatch Act, government-wide regulations implementing that Act, and State Department policies,” according to a letter sent by Rep. Joaquin Castro to Deputy Secretary of State Stephen Biegun. The Hatch Act prohibits federal employees from participating in certain political activities. On Feb. 18, 2020, Biegun sent State Department employees an email – approved by Pompeo – of legal memos about the limitations on the political activity for U.S. diplomats and other State staffers. And in July, Pompeo sent a memo warning staffers — and specifically Senate-confirmed officials — not to attend political conventions. Castro said that Pompeo’s speech is not only “highly unusual and likely unprecedented,” but that “it appears that it may also be illegal.” (Daily Beast / Politico / Axios / Washington Post / NBC News)

7/ Trump will nominate Chad Wolf to be the permanent, Senate-confirmed secretary of the Department of Homeland Security. Wolf has been the acting secretary since November 2019, and the department has not had a confirmed secretary since April 2019 when former Secretary Kirstjen Nielsen was forced to resign. Since taking over from acting Secretary Kevin McAleenan, Wolf has overseen a crackdown at the U.S.-Mexico border and was responsible for sending Homeland Security agents to Portland, Oregon in July. A recent Government Accountability Office report found that Wolf’s appointment is invalid. (Axios / Politico / ABC News / CNN / CBS News / Wall Street Journal)

8/ Trump’s reelection campaign has paid his private companies at least $2.3 million for rent, food, lodging, and other expenses, according to Federal Election Commission filings. Trump, the richest president in American history, has yet to donate to his 2020 campaign. (Forbes)

9/ U.S. Citizenship and Immigration Services canceled a planned furlough of more than 13,400 employees, which would have crippled the processing of applications for green cards, work permits, U.S. citizenship and other immigration benefits. USCIS funds itself almost entirely through the fees it collects, unlike most other federal agencies. The agency said it was considering a planned furlough of more than 13,400 employees after citizenship and immigration applications fell because of the coronavirus pandemic. In May, the agency asked Congress for an emergency $1.2 billion infusion, but a bailout faded following a standoff between Congress and the Trump administration on a COVID-19 relief package last month. (Wall Street Journal / CBS News)



Three years ago today: Day 218: Must do better.