FDA Commissioner summoned in White House over COVID-19 vaccine approval delay

WHAT YOU NEED TO KNOW:

• Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn was summoned to the White House, attending a meeting with Chief of Staff Mark Meadows on Tuesday.
• Hahn was reportedly asked why he was working remotely in his agency’s office in North Carolina last month amid the urgent need to authorize the emergency use of Pfizer’s COVID-19 vaccine.
• In August, President Donald Trump expressed his dismay over Hahn, accusing him of delaying the processing of vaccine approval to negatively impact his reelection bid.

A source told NBC News that White House Chief of Staff Mark Meadows has summoned Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn to asked why the agency was not expediting the usage approval of Pfizer’s COVID-19 vaccine.

Co-creating the vaccine, Pfizer, alongside German pharmaceutical company BioNtech, has applied for FDA’s emergency clearance on November 20. The agency set a December 10 meeting to decide on the drugmakers’ request for endorsement.

A senior White House aide told CNBC that Hahn prepared talking points focusing “purely on vaccines and therapies.” The FDA head outlined a status update “on where things stand.”

Hahn came to the White House before the 9:30 am meeting with Meadows. He left shortly before 11:00 am.

In his preemptive statement, Hahn told Axios: “Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision.”

As the first to report the meeting, Axios said Meadows asked why Hahn was working remotely in North Carolina in mid-November. It looked like the commissioner went for a vacation amid pressed time for vaccine validation.

FDA’s spokesperson Michael Felberbaum, however, said that Hahn did not go to the Carolina coast to have a vacation.

The commissioner “recently quarantined out of an abundance of caution following a potential exposure to COVID-19 while working at the FDA’s White Oak campus,” Felberbaum said.

“Dr. Hahn chose a remote location to quarantine and he continued working, as he has done throughout the pandemic. The agency followed its contact tracing and notification protocols, following CDC guidelines, for the very small number of other potentially impacted employees,” the spokesman said in a statement.

Felberbaum added that the FDA’s White Oak campus in Silver Spring, Maryland “is a ghost town… so we are all very surprised that an exposure is even possible.”

During his interview with The Washington Post, Operation Warp Speed advisor Dr. Moncef Slaoui said that he was not privy about the meeting of Meadows and Hahn. The top official working on the vaccine noted that he only knew about the meeting when he was asked by the news agency.

A spokesman from the White House refused to comment about Meadows and Hahn’s sitdown discussion.

The meeting marked another event of tension between President Donald Trump and the FDA. In his Twitter post last August, the president called out Hahn for intentionally delaying the COVID-19 vaccine authorization process to hurt his reelection bid, without any credible basis.

Source: CNBC.com