OCTOBER VACCINE SURPRISE WATCH: Upcoming FDA Advisory Meeting Key Test for Trump, Political Appointees

FDA’s Vaccines and Related Biological Products Advisory Committee scheduled to meet this Thursday, October 22 – streaming here

Washington, DC – Today, in advance of the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee meeting scheduled for October 22, 2020 at 10am ET, Accountable Pharma released the following statement highlighting the importance of this meeting as a key step in restoring public trust and confidence that any announcement of an Emergency Use Authorization in the coming weeks will be guided by science and public health, not President Trump’s political considerations.

“President Trump is growing increasingly desperate to persuade people that a COVID-19 vaccine is coming ‘momentarily’ and has already called the updated FDA safety and efficacy guidance a ‘political hit job,’ so this upcoming meeting is a key moment to look out for another Trump tantrum or more pressure from his political appointees to put politics ahead of public health,” said Eli Zupnick, spokesman for Accountable Pharma.

“We hope and expect for this advisory committee to help restore public trust by being crystal clear on Thursday that they will be guided only by public health considerations in their recommendations. And we call on the Trump Administration to avoid further undermining public trust by attacking the scientists and public health experts who are expected to discuss clear standards that seem to preclude a vaccine approval or authorization by what Trump called “that special date.”

According to Politico, the FDA has said that “the full committee roster, including possible temporary replacements, will be published 48 hours before the Oct. 22 meeting.”

The Trump Administration has a history of inappropriately pressuring the FDA on Emergency Use Authorizations. This was especially notable in the case of hydroxychloroquine, when Food and Drug Administration (FDA) Commissioner Stephen Hahn caved to President Trump’s pressure by issuing an emergency use authorization for the unproven treatment after President Trump called it a “game changer” and explicitly called for it to be approved, which then had to be revoked in the face of continued evidence of the drug’s dangers. And we saw it happen when President Trump and Commissioner Hahn held a press conference to hype blood plasma treatments, which was roundly criticized as a “major breach,” “bullying…at the Highest Level,” an “alarming development,” and based on “nonsensical, inflated claims.” Hahn subsequently apologized.

President Trump has also personally attacked and bullied government scientists, calling them members of the “deep state” and explicitly saying that they may delay a vaccine until November 4th in order to hurt him politically.

Additional background

White House Blocked FDA Guidance On COVID Vaccine Safety, Efficacy Due To Concerns Over Provision That Would Likely Push Authorization Past November 3. “Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process. Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.” [New York Times, 10/5/20]

Headline: New York Times: “White House Blocks New Coronavirus Vaccine Guidelines.” [New York Times, 10/5/20]

Headline: Politico: “White House cited drug companies’ objections in overruling FDA’s vaccine standards.” [Politico, 10/5/20]

Trump Complained On Twitter That FDA Vaccine Guidance Was “Political Hit Job.” “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA” [Twitter – President Trump, 10/6/20]

A timeline of political pressure on health officials

October 13: President Trump took another swipe at his government’s top infectious diseases specialist Dr. Anthony Fauci, saying “Tony’s pitching arm is far more accurate than his prognostications.”
October 13: President Trump took another swipe at his government’s top infectious diseases specialist Dr. Anthony Fauci, saying “Tony’s pitching arm is far more accurate than his prognostications.”
October 7: President Trump released a video that, among other claims, hypes experimental drugs that he personally used and that he claims he will pressure the Food and Drug Administration (FDA) to approve. Trump once again contradicted members of his own Administration and claimed that the fact that a vaccine isn’t available “before Election Day” is “political.”
October 6: “White House Agrees to FDA’s Guidelines for Vetting Covid-19 Vaccines”…Trump calls it “political hit job.”
October 5: Reports emerge that the White House, in consultation with the drug industry, has overruled the FDA and plans to block the new guidance.
September 28: White House objections may prevent FDA from releasing stricter guidelines drawn up for the emergency authorization of coronavirus vaccines.
September 21: President Trump once again claimed that a vaccine will be approved “within a matter of weeks” and that it will be available to the public “long before the end of the year, maybe…maybe by the end of October,” contradicting his top public health officials.
September 16: President Trump publicly scolded the Centers for Disease Control and Prevention Director Robert Redfield following his testimony to Congress that mask use was critical in preventing the spread of COVID-19 and that a vaccine would likely not be available to the American public until “late second quarter, third quarter 2021.”
August 30: WaPo: “Inside Trump’s pressure campaign on federal scientists over a covid-19 treatment”
August 25: NPR: “FDA’s Hahn Apologizes For Overselling Plasma’s Benefits As A COVID-19 Treatment”
August 24: “Trump’s FDA Intimidation Campaign Pays Off With Politically-Convenient Announcement; Further Undermines Trust in Vaccine, Treatment Approval Process”
August 22: Trump dials up the pressure with another tweet “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
August 19: Trump insinuates that FDA is trying to hurt him politically through delay: “It could be a political decision because you have a lot of people over there who don’t want to rush things because they want to do it after November 3”
August 18: “Trump Dials Up Pressure for Pre-Election Vaccine, Wonders if “Deep State” Will Delay Vaccine Announcement Until November 4th”
August 17: “Trump Pushes Another COVID-19 “Miracle Cure” Hawked By His MyPillow Buddy, Housing Secretary; Watchdog Urges FDA to Stand Up to Pressure”
August 6: “Watchdog Group to FDA: Patients Need More Than Words On Vaccine Safety Assurance; Supports Health Expert Calls for Additional Transparency”
July 15: “NEW REPORT – Operation Warp Speed at Two Months: $4 Billion for Drug Companies, Zero Assurances for Patients and Taxpayers”
June 25: “New Vaccine Report Highlights Trump Administration’s Drug Company Connections, Need for Vaccine Program Transparency”
June 24: “As Dr. Fauci Expresses Hope for Vaccine By End of Year, Patients Need Assurances That Trump Pressure Won’t Corrupt Development Process”
June 8: “Watchdog Calls for Independent Patient Advocate to Audit ‘Operation Warp Speed’”
May 26: “Lack of Transparency, Conflicts of Interest Surround Trump’s “Operation Warp Speed” Vaccine Development Program”

###

Stay Informed