Trump claimed, without justification, that new tighter FDA vaccine guidelines were a ‘political hit job,’ hours after the White House approved them



a man wearing a suit and tie: President Donald Trump removes his mask upon return to the White House from Walter Reed National Military Medical Center on October 5, 2020 in Washington, DC. Win McNamee/Getty Images


© Win McNamee/Getty Images
President Donald Trump removes his mask upon return to the White House from Walter Reed National Military Medical Center on October 5, 2020 in Washington, DC. Win McNamee/Getty Images

  • Trump claimed the Food and Drug Administration’s (FDA’s) tougher guidelines for COVID-19 vaccine developers are a “political hit job” on him.
  • The White House approved the new regulations on Tuesday.
  • The FDA says that before vaccine makers submit an emergency-approval application they should follow trial participants for at least two months after a final dose.
  • These stricter guidelines will most likely prevent any vaccine being approved before the presidential election on November 3 — a deadline Trump had hoped vaccine makers could hit.
  • Visit Business Insider’s homepage for more stories.

President Donald Trump has accused the Food and Drug Administration (FDA) of launching a “political hit job” on him, hours after the White House accepted the regulator’s stricter guidelines for coronavirus vaccine developers.

Trump has consistently said he hopes to have a vaccine ready before election day, but the new FDA guidelines will make it difficult for any COVID-19 vaccine to be approved before the November 3 vote. 

He lashed out at the FDA in a tweet on Tuesday evening, tagging commissioner Stephen Hahn.

He did not offer any evidence for his claim the new guidelines were motivated by politics.

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The tougher guidelines were cleared by the Office of Management and Budget on Tuesday after a two-week hold-up, during which they were reportedly blocked by senior White House officials, including Mark Meadows, chief of staff.

In the guidelines, the FDA said that before vaccine makers submit an emergency-approval application they should monitor trial participants for a minimum of two months after their final dose in phase-three clinical trials. The agency also expects vaccine developers to document five cases of severe infection in volunteers who took the placebo instead of the vaccine.

Four vaccines have entered the final stage of testing in the US, including one from Pfizer and one from Moderna. The two companies kicked off their trials in July.

Volunteers usually receive their second dose less than a month after their first, but two months of monitoring make it unlikely that either company will have have enough data before November.

Moderna’s CEO said on September 30 that the firm wouldn’t be able to submit an application for emergency approval until late November at the earliest, as it wouldn’t have enough safety data, per the Financial Times.

Coronavirus has claimed more than 210,000 lives in the US so far, and infected more than 7.5 million people.

Among those that have been infected is Trump himself: He tweeted on October 2 that he and Melania Trump had tested positive for the virus. After being flown to Walter Reed Medical Center, he received two experimental treatments to fight the infection. He has since returned to the White House, where staff are reportedly anxious about catching COVID-19 from him, per multiple

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White House OKs FDA asking for 2 months monitoring, likely delaying vaccine authorization past Election Day

The White House denied reports it had tried to block the new FDA guidance.

A spokesperson for the White House budget office denied those reports and said the approved guidance was never blocked and went through the normal review process.

Trump lashed out at the news on Twitter Tuesday night, writing, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” He also tagged FDA Commissioner Stephen Hahn in the tweet.

In September, Trump had said that the White House might not approve the new guidance, given what it could mean in terms of timing. “We may or may not approve it,” he told reporters, suggesting the FDA was reacting to questions about White House pressure to act faster, saying it “was a political move more than anything else.”

The guidance was posted on the agency’s website on Tuesday and as part of a packet of background material posted ahead of the vaccine advisory board’s scheduled meeting on COVID vaccine candidates on Oct. 22.

The FDA is laying out criteria for an emergency authorization of a vaccine candidate, not a full approval, and has repeatedly sought to encourage the public it will make decisions based only on the science and data from clinical trials regardless of political pressure.

FDA officials have said they expect an emergency authorization to target specific populations at higher risk for the virus — including health care workers or older populations living in group settings — and that a vaccine would not be widely available outside those groups until into next year.

Experts including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have said it takes about a month and a half for some side effects or problems to present themselves.

“Most of the adverse events that you’re talking

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House Democrats Probe White House Over Swaying FDA, CDC on Virus

(Bloomberg) — A House Oversight subcommittee wants two federal health agencies at the fore of the U.S. coronavirus response to disclose information about the White House’s involvement in scientific decisions, according to letters reviewed by Bloomberg News.



a sign on the side of a building: A pedestrian wearing a protective face mask walks past the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, U.S, on Saturday, March 14, 2020. As the novel coronavirus has spread in the U.S., the CDC is under increasing heat to defend a shaky rollout of crucial testing kits.


© Bloomberg
A pedestrian wearing a protective face mask walks past the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, U.S, on Saturday, March 14, 2020. As the novel coronavirus has spread in the U.S., the CDC is under increasing heat to defend a shaky rollout of crucial testing kits.

The letters addressed to the leaders of the Food and Drug Administration and the Centers for Disease Control and Prevention seek documents about agency actions submitted to the White House for review, including communications, comments, first drafts and documents that show changes made during the review process.

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The letters sent Monday are signed by Rep. Raja Krishnamoorthi, an Illinois Democrat who is the chairman of the Subcommittee on Economic and Consumer Policy of the House Committee on Oversight and Reform.

The subcommittee’s letters express concern about the influence of non-scientists and political appointees over public-health decisions, including how the FDA will assess experimental coronavirus vaccines now in trials. The letter to the CDC asks about what it calls “White House censorship” of CDC guidance.

President Donald Trump has repeatedly said that a coronavirus vaccine will be widely available faster than top government scientists say is likely. The FDA has been expected to issue final guidelines on how vaccines may be cleared for emergency use, a document intended to assuage concerns that a shot might be rushed to market for political reasons.

Trump said last month that the White House might not approve the FDA’s guidelines for vaccine authorization. They haven’t been published as of Monday morning. Krishnamoorthi asked the FDA to publish such guidelines in a previous letter.

Extensive Reviews

Monday’s letters ask about the role of the White House Office of Information and Regulatory Affairs, known as OIRA, in decisions at the scientific agencies. OIRA, part of the Office of Management and Budget, has legal authority to review federal regulations.

Representatives for the CDC and FDA didn’t immediately comment. A spokesperson for the White House Office of Management and Budget, which oversees OIRA, didn’t immediately respond to a request for comment.

Bloomberg News reported last month that OIRA and other agencies performed extensive reviews of CDC publications related to the coronavirus that delayed guidelines for nursing homes, schools, houses of worship, and businesses, sometimes for weeks.

A new process to review nearly every public document or guideline related to Covid-19 delayed CDC publications in layers of bureaucracy from across the federal government, Bloomberg reported, citing people familiar with the matter.

Administration officials defended the process, saying it was within OIRA’s authority, and didn’t diverge from past practice.

The White House Coronavirus Task Force sought to make sure CDC’s communications were “fully reviewed, studied, and vetted by administration officials, including the top medical doctors, for accuracy, effectiveness,

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Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference

The White House’s involvement appears to go beyond the perfunctory review that agency officials had expected, and is likely to reinforce public concerns that a vaccine may be rushed to benefit the president’s reelection campaign. Polls show that the number of people who say they’re willing to take a coronavirus vaccine if it were available today has nosedived from 72 percent in May to 50 percent as of early this month, according to Pew Research Center, largely because of concerns that politics, rather than science, is driving the process.

Trump has repeatedly said a vaccine would be available by Election Day, or possibly sooner, worrying scientists that he might attempt to intervene in the review process. Companies will begin reporting safety and effectiveness data in coming weeks and months. And in conversations with some advisers, the president has directly tied the vaccine to his reelection chances, according to a senior administration official, who spoke on the condition of anonymity to discuss private deliberations.

The White House’s decision to weigh in on the FDA plan was assailed by former FDA commissioners who had served both Republican and Democratic presidents.

“I don’t know of any precedent where the White House asked to adjudicate scientific and clinical guidances, even in past public health emergencies,” said Scott Gottlieb, Trump’s first FDA commissioner. “To build trust among patients and providers, you wanted to leave these matters to the FDA process, which has a lot of rigor and integrity.”

Robert Califf, commissioner under President Barack Obama, said White House officials lack the expertise to assess the FDA’s safety protocols. “For the president to weigh in is not good,” he said, “and it sets a precedent, which is worrisome in many regards, and makes you worry about what he’ll do about the decision itself about individual vaccines.”

The push from the White House comes during a week in which top health administration officials, including FDA Commissioner Stephen Hahn, vowed there would be no political interference in the vaccine approval process and sought to boost public trust in the process.

So far, the White House has not asked the FDA to withdraw or change the guidance for an emergency authorization of the vaccine — a far quicker process than a formal approval that gives the FDA the flexibility to set a lower bar for safety and effectiveness. The agency expects to use the process because of the urgency of the situation. In a Wednesday phone call, White House Chief of Staff Mark Meadows told Hahn the agency had to provide the detailed justification for the guidance, according to two people familiar with the call who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, which had planned to release the guidance this week, instead has been working on detailed scientific justifications for the questions raised by White House officials, according to two people who spoke on the condition of anonymity to discuss internal deliberations. White House officials are especially interested in the agency’s recommendation

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NIH Head Says FDA Best Judge of Vaccine Safety, After Trump Says White House Must Approve Rules

Dr. Francis Collins, director of the National Institutes of Health (NIH), has said the Food and Drug Administration (FDA) is best placed to judge whether a potential coronavirus vaccine is safe and effective. He made the remarks after President Donald Trump claimed the White House can overrule potential safety guidelines set out by the FDA.



a close up of Francis Collins wearing glasses and looking at the camera: Dr. Francis Collins, director of the National Institutes of Health, gives an opening statement during a Senate Health, Education, Labor, and Pensions Committee hearing to discuss vaccines and protecting public health during the coronavirus pandemic. September 9, 2020 in Washington DC.


© Getty
Dr. Francis Collins, director of the National Institutes of Health, gives an opening statement during a Senate Health, Education, Labor, and Pensions Committee hearing to discuss vaccines and protecting public health during the coronavirus pandemic. September 9, 2020 in Washington DC.

On Wednesday’s The Situation Room, CNN presenter Wolf Blitzer asked Collins whether the White House or the FDA has the final say on whether a coronavirus vaccine is approved.

Collins said that he did not know as he is not a lawyer, but that the FDA is in the “best” position to judge whether a vaccine is safe and effective as the agency that has the experience and scientific expertise.

“You already have a problem in this country where a lot of people are worried about whether this vaccine is going to be something that they want to take. The last thing we need to do is create another cloud of uncertainty on whether this is being done appropriately, so that we can reassure people it’s something they’d want to take advantage of,” he said.

The physician-geneticist made the comments after Trump said the White House could override FDA guidelines on the approval of a vaccine. Trump was responding to reports the FDA was considering stricter rules for an emergency use authorization (EUA) of a coronavirus

vaccine. A EUA has a lower threshold than an approval. Reports suggested this would push authorization past the November 3 presidential election. The president has repeatedly forecast a vaccine could be ready by election day. An FDA spokesperson declined to comment when contacted by Newsweek.

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“We’re looking at that and that has to be approved by the White House. We may or may not approve it. That sounds like a political move,” the president said at a news conference at the White House on Wednesday.

An Axios/Ipsos poll published Tuesday, the day that the 200,000th U.S. death in the pandemic was recorded, found most Americans would not get a first-generation COVID-19 vaccine as soon as it is available. A separate ABC/Ipsos poll published over the weekend found most Americans do not have confidence in either Trump or Democratic presidential nominee Joe Biden to confirm a vaccine is effective and safe. Earlier in the month, a KFF Health Tracking Poll found respondents were very or somewhat worried the FDA will rush to approve a coronavirus vaccine without making sure that it is safe and effective due to political pressure from the Trump Administration.

On Wednesday, FDA Commissioner Stephen Hahn told a Senate hearing on

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White House bars FDA commissioner from testifying before committee

The White House blocked FDA Commissioner Dr. Stephen Hahn from testifying before the Energy and Commerce Committee, Politico reported.

Energy and Commerce Committee Chairman Democratic Rep. Frank Pallone, Jr. and Health Subcommittee Chairwoman Democratic Rep. Anna G. Eshoo said in a statement Friday that “despite bipartisan interest and our request for Commissioner Hahn to appear before the Energy and Commerce Committee this month, the White House has blocked Dr. Hahn from testifying.”

The lawmakers noted the committee’s “concerns about the Trump Administration’s ongoing political interference into the COVID-19 response efforts of our public health agencies,” and stressed that “the American people deserve to hear” from Hahn to “ensure that the agency’s COVID-19 decisions remain science-based.”

Meanwhile, the FDA has recently ousted two Trump appointees at the agency.

In early September, John Wagner, who was appointed by the Trump administration to lead the FDA’s office of external affairs was replaced with Hedii Rebello, who spent over 14 years at the FDA.  This replacement came days after Hahn fired the Trump appointed FDA spokesperson Emily Miller days after she started the job. Miller was reportedly involved with preparing for the FDA’s announcement to issue an emergency authorization for convalescent plasma, which was met with swift backlash from medical experts, for which Hahn apologized.  

A White House spokesperson confirmed to Politico that Hahn was barred from testifying so that
“health officials can keep their time and energy focused on responding to the coronavirus.”

Earlier this month, it was reported that Michael Caputo, the head spokesperson for the Department of Health and Human Services, and his scientific advisor, Dr. Paul Alexadnder, may have successfully delayed CDC reports that conflicted with the president’s political viewpoints, according to Politico. Caputo, a longtime Republican political strategist before being appointed as HHS spokesman in April, is currently taking medical leave. 

 

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Democratic chairman says White House blocked FDA commissioner from testifying

The White House blocked Food and Drug Administration (FDA) Commissioner Stephen Hahn from testifying before the House panel overseeing the administration’s response to the coronavirus pandemic, its Democratic leaders announced Friday.  

“The American people deserve to hear Commissioner Hahn’s response to those concerns during a public hearing and what actions he is taking to ensure that the agency’s COVID-19 decisions remain science-based,” Reps. Frank Pallone (D-N.J.), chair of the Energy and Commerce Committee, and Anna EshooAnna Georges EshooHillicon Valley: Zuckerberg acknowledges failure to take down Kenosha military group despite warnings | Election officials push back against concerns over mail-in voting, drop boxes Democrat asks intel agencies if they’re surveilling members of Congress Overnight Health Care: Supreme Court to hear ObamaCare arguments 1 week after election | NYC positive COVID-19 tests hit record low MORE (D-Calif.), who chairs its health subcommittee, said in a statement. “The White House’s muzzling of the FDA’s top scientist further injures public trust and confidence in FDA.”

Earlier this week Democrats on the House Oversight and Reform Subcommittee on Economic and Consumer Policy also accused the White House of blocking trade advisor Peter Navarro from testifying before their panel.

A White House spokesperson told The Hill Hahn was blocked from testifying because it’s “part of the administration’s existing protocol to make sure health officials can keep their time and energy focused on responding to the coronavirus.”

Hahn has testified before Congress four times since the start of the pandemic, the last time being in late June. Since then, three potential coronavirus vaccines moved to phase three trials, which will determine safety and effectiveness. 

Democrats have been skeptical of the administration’s vaccine efforts, which they say may be overlooking important safety measures in an effort to have results before the November elections. 

“I am often asked about how and when FDA will authorize or approve a vaccine to protect against [coronavirus]. Here is my answer: when the agency’s scientific experts have completed their review and are ready to do so, and not a moment before,” Hahn tweeted Friday. 

Late last month Hahn ousted Trump-appointed spokesperson Emily Miller after 11 days on the job amid the fallout over the agency’s decision to issue an emergency use authorization for convalescent plasma to treat COVID-19 patients.

Michael Caputo, a Trump-appointed Health and Human Services (HHS) communications official, announced Wednesday he was taking medical leave after making “comments that reflected poorly on the office and HHS.”

Hahn is still scheduled to appear before the Senate Health, Education, Labor and Pensions Committee on Tuesday, alongside infectious disease expert Anthony FauciAnthony FauciOvernight Health Care: CDC reverses controversial testing guidance | Billions more could be needed for vaccine

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White House blocked FDA commissioner from testifying to House panel

Hahn, who is scheduled to testify before a Republican-led Senate panel next week, in recent weeks has worked to reestablish his agency’s independence amid pressure from President Donald Trump to deliver faster on coronavirus vaccines and treatments. Hahn ousted the agency’s top spokesperson, a Trump appointee, after a disastrous rollout of an emergency use authorization for convalescent plasma. He also has repeatedly pledged the FDA will be transparent about how it evaluates Covid-19 vaccine candidates.

“I am often asked about how and when FDA will authorize or approve a vaccine to protect against [Covid-19]. Here is my answer: when the agency’s scientific experts have completed their review and are ready to do so, and not a moment before,” Hahn tweeted Friday.

Background: Hahn appears to be the most recent administration official blocked from testifying before a House panel on the administration’s coronavirus response. The White House earlier this week prevented trade adviser Peter Navarro from testifying before a House Oversight subcommittee about the administration’s use of the Defense Production Act to manufacture ventilators.

What’s next: Hahn is still scheduled to appear at a Senate HELP Committee hearing on Sept. 23 alongside infectious disease expert Anthony Fauci, CDC Director Robert Redfield and HHS testing czar Brett Giroir.

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