The Washington PostDemocracy Dies in Darkness

House panel: Trump sought to pressure FDA on covid vaccines, treatment

The report offers fresh details about that campaign and how it rattled agency officials

Former Food and Drug Administration commissioner Stephen Hahn, seen in 2020. (Jabin Botsford/The Washington Post)

Trump officials repeatedly stalled the Food and Drug Administration’s plan to extend safety studies of coronavirus vaccines in fall 2020, as President Donald Trump pressed the agency for a faster timeline so the vaccines could be authorized before Election Day, according to emails, text messages and interviews by a congressional panel probing the pandemic response.

White House officials such as trade adviser Peter Navarro and outside allies such as TV host and physician Mehmet Oz also pressed federal officials in 2020 to authorize the antimalarial drug hydroxychloroquine as a coronavirus treatment, with Navarro and a deputy working behind the scenes to have a hospital craft a request to the FDA for widespread access to the debunked therapy touted by Trump, the House select subcommittee on the coronavirus crisis concluded in a report released Wednesday.

The report adds new details to the contemporaneous reports about the Trump White House’s efforts to sway the FDA in the first year of the pandemic, a pressure campaign that rattled agency officials and threatened to undermine confidence in vaccines and other medical treatments, former commissioner Stephen Hahn told the panel.

“I felt very strongly about the fact that our scientists had created this [vaccine] guidance. I totally supported the science and the clinical data behind it, and I objected to any suggestion that it be changed,” Hahn said in a January 2022 interview that the panel made newly public. “I also felt any changes would be obviously reported and would further reduce vaccine confidence.”

Officials and public health experts have also said that Trump’s attacks on the FDA left lingering scars on the agency and contributed to fading trust in health officials responding to the pandemic across the government.

“These assaults on our nation’s public health institutions undermined the nation’s coronavirus response — and are precisely why we must never again settle for leaders who prioritize politics over keeping Americans safe,” Rep. James E. Clyburn (D-S.C.), the panel’s chair, said in a statement.

How the ‘deep state’ scientists vilified by Trump helped him deliver an unprecedented achievement

Republicans have decried the Democrat-led panel’s work as politically motivated and vow to launch their own investigations into Anthony S. Fauci, the government’s top infectious-disease expert, and the Biden administration’s coronavirus response, should they retake one or both chambers of Congress this fall.

The Centers for Disease Control and Prevention loosened many of its coronavirus recommendations and placed more responsibility on individuals. (Video: The Washington Post)

“For over two years, congressional Democrats have refused to hold a single hearing on the origins of COVID, or our government’s possible financial involvement in gain-of-function research. That will change when House Republicans take the majority next year,” Rep. Steve Scalise (La.), the panel’s top Republican, wrote in a statement Monday, after Fauci announced he was stepping down in December. Gain-of-function research involves using laboratory techniques to enhance a virus, which some argue without evidence led to the pandemic.

The House report issued Wednesday focuses on several FDA decisions in 2020, including officials’ debates over how best to expedite vaccines while ensuring they were safe and effective. Trump publicly and privately campaigned for the FDA to move faster, accusing it of deliberately postponing decisions until after the Nov. 3 election to undercut his reelection prospects.

“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,” Trump wrote in an Aug. 22 tweet, tagging then-commissioner Hahn. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

A spokesman for Trump did not immediately respond to a request for comment.

Behind the scenes, senior FDA officials concluded by September that they wanted to review two months of safety data after participants in clinical trials had received their second shot of the Pfizer-BioNTech or Moderna vaccines — a decision that would delay the agency’s vaccine authorization decisions until after the election.

“We were not going to cut corners in our assessment,” Hahn told the panel, adding the agency had already streamlined a vaccine-authorization process that typically took far longer, and he feared fallout on vaccine confidence.

“I was concerned about the entire environment: a presidential election, bitter divisions in the country and in Congress. And to me, it was a pretty significant combination of factors that led to a decrease in … confidence in science and medicine,” Hahn said.

But after the FDA submitted its planned timeline for approval in September 2020, Trump officials delayed the agency’s request, pressing for its justifications, prompting FDA officials to fret about the impact.

“The ambiguity here is actually creating more problems than a decision one way or the other” on finalizing the guidance to vaccine makers, Peter Marks, the FDA’s top vaccine official, wrote in a Sept. 29 email to Hahn and the agency’s then-chief of staff, Keagan Lenihan.

The FDA ultimately circumvented the White House on Oct. 6, publishing its vaccine guidance in briefing documents for the agency’s outside advisers. The White House later that day formally approved the guidance — but Trump mocked the decision on social media.

“New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump wrote on Twitter, again tagging Hahn in his tweet.

In his panel interview, Hahn acknowledged the FDA faced pushback over its timeline from the White House and senior health officials, such as former Health and Human Services secretary Alex Azar. But Hahn he said he was confident the agency had prioritized safety.

“It came down to this as the most appropriate and pragmatic way to assess the vaccines,” Hahn said. “Balancing … speed with making sure we got the decision right.”

Through a spokesman Wednesday, Hahn declined to comment on the report. Azar did not respond to a request for comment.

The panel’s report also details the months-long battles over hydroxychloroquine, the malaria drug also used to treat some autoimmune conditions that Trump and some others seized on as a coronavirus cure despite scant evidence. Beginning in March 2020, Hahn and other health officials were inundated with messages from pro-hydroxychloroquine commentators, including emails from Fox News host Laura Ingraham and Oz, who called for patients to immediately begin receiving the treatment. Randomized studies later showed that patients given the drug did no better than those receiving a placebo.

“We have a potential pandemic solution at our finger tips,” Oz wrote March 23 to Jared Kushner, then a White House senior adviser and Trump’s son-in-law. The TV host cited data provided by a French scientist that “after 6 days of treatment, 100 percent of trial patients were free of virus” and said that a U.S. study on the drug should be a “national priority.”

Oz is now running as the Republican candidate for Senate in Pennsylvania. Through a campaign spokeswoman, Oz defended his work on hydroxychloroquine, saying that at the start of the pandemic, he “spoke with health experts worldwide who were seeing hydroxychloroquine and azithromycin as viable treatment options for desperately ill covid patients and [Oz] offered to fund a clinical trial at Columbia University.”

The FDA initially authorized hydroxychloroquine March 29, despite the skepticism of career scientists worried about the scant data that it was effective. But the agency revoked authorization for the treatment in June, amid mounting evidence that it did not work. “The scientific data is really quite evident now about the lack of efficacy,” Fauci said on CNN on May 27, warning of potentially harmful side effects to the heart.

The reversal frustrated Navarro, a top trade adviser to Trump, and Steven Hatfill, a deputy and virologist, who strategized on how to get the FDA to reverse its decision, such using allies including Sen. Ron Johnson (R-Wis.), according to emails obtained by the panel.

In one instance, Navarro and Hatfill worked with a Michigan-based hospital system, Henry Ford Health, to bring pressure. For instance, Hatfill crafted a request letter that the health system could submit to the FDA, although he instructed the organization “NEVER mention the White House together with my name” in a May 2020 email to a physician leading the system’s work on hydroxychloroquine. Regardless, the FDA in August denied the hospital system’s request, having repeatedly warned about safety concerns related to the drug.

“FDA decided it will not renew the [emergency authorization] for hydroxy,” Hatfill wrote in an August 2020 email to himself that was obtained by the panel. “That’s OK because it was already arranged for Hahn to be pulled into Senator Johnson’s Committee to answer some questions. The Senator is pissed off and I wrote the questions -so it should be a good s---show.”

Through a spokesman, Hatfill acknowledged his work with Henry Ford Health and said his actions to encourage hydroxychloroquine were appropriate. “We never wrongly pressured anyone. We simply followed the science and the overwhelming evidence as detailed in several studies available at the time,” Hatfill wrote in a statement.

In a statement, Navarro also defended his advocacy for hydroxychloroquine, citing excerpts from his memoir, “In Trump Time,” which details his clashes with Fauci, Hahn and other officials over the drug. “The partisan House Select Subcommittee report ‘wrongly’ perpetuates one of the most deadly lies of the pandemic, namely that the safe and powerful therapeutic to treat COVID, hydroxychloroquine, was somehow dangerous.,” he wrote.

The FDA did not respond to specific questions about the report, but said in a statement that career staff had worked round-the-clock throughout the pandemic “to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency.”

Henry Ford Health said it would launch an investigation into the report’s allegations. “Like other health systems, we participated in a number of studies and clinical trials, including for hydroxychloroquine, during a time when there were no known treatments for COVID-19. When our own studies determined that hydroxychloroquine was not an effective treatment, we suspended the study and any use of the drug. … As always, the safety of our patients is our top priority.”

Alexa Henning, a spokeswoman for Johnson, wrote in a statement that the senator from Wisconsin was being wrongly attacked by the “COVID cartel.”

Coronavirus: What you need to know

Vaccines: The CDC recommends that everyone age 5 and older get an updated covid booster shot designed to target both the original virus and the omicron variant. Here’s some guidance on when you should get the omicron booster and how vaccine efficacy could be affected by your prior infections.

Variants: Instead of a single new Greek letter variant, a group of immune-evading omicron spinoffs are popping up all over the world. Any dominant variant will likely knock out monoclonal antibodies, targeted drugs that can be used as a treatment or to protect immunocompromised people.

Tripledemic: Hospitals are overwhelmed by a combination of respiratory illnesses, staffing shortages and nursing home closures. And experts believe the problem will deteriorate further in coming months. Here’s how to tell the difference between RSV, the flu and covid-19.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. In the U.S., pandemic trends have shifted and now White people are more likely to die from covid than Black people. Nearly nine out of 10 covid deaths are people over the age 65.

For the latest news, sign up for our free newsletter.

Loading...