FLASHBACK: “In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A”

Secretary Azar has the legal authority to issue emergency use authorizations of vaccines even against advice of outside committee and career scientists

NEW: “White House puts ‘politicals’ at CDC to try to control info”

Washington, DC – As we head into the final weeks before what Trump called “that special date” that he hopes to have a vaccine approved by, Accountable Pharma is calling on Secretary of Health and Human Services (HHS) Alex Azar to publicly commit that he will not use his legal authority to authorize emergency use of a COVID-19 vaccine before career scientists and their outside committee say it’s safe and effective. 

Secretary Azar may claim the right to make emergency use authorizations that aren’t supported by career scientists or even his own FDA, but as President Trump becomes increasingly desperate to deliver on his promise of a vaccine coming ‘momentarily,’ Secretary Azar must publicly commit that he won’t do that to help make sure that people across the country can trust any government announcements in the coming weeks,” said Accountable Pharma spokesman Eli Zupnick.

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. 

In September, FDA Commissioner Hahn admitted that the FDA and HHS had “the authority” to overrule the FDA’s outside committee for Emergency Use Authorizations. Relevant excerpt of transcript:

Hahn: …So the authority to FDA to me as commissioner and then to the FDA as a whole is delegated by statute, by law from the Health and Human Services – so the Secretary delegates that to us within the agency. 

…Host: But you’re legally – you or the Secretary of HHS – could you overrule the committee? You wouldn’t, you say, but is it legally possible?

Hahn: There is that authority, but as I’ve said there’s no intent to do that whatsoever.

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”

###