FDA commissioner meets with White House chief of staff amid tensions over vaccine approval
Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration, was seen arriving at the White House on Tuesday morning ahead of his scheduled meeting with President Donald Trump's chief of staff, Mark Meadows.
It's unclear if Trump is participating in the meeting.
A source told ABC News that the meeting was called amid frustrations that the FDA hasn't moved faster in authorizing emergency use of a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.
Hahn issued a statement ahead of the meeting, defending his agency's timeline.
"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," Hahn said. "We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy."
The FDA is already moving at an accelerated pace in going through data related to the vaccine candidate, but it's a process that takes weeks given the sheer volume and the stakes for getting it right.
"The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review," a spokesperson for the agency told ABC News in a statement Tuesday. "Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects."
Meanwhile, an FDA spokesperson also confirmed to ABC News that Hahn had recently self-quarantined "out of an abundance of caution," following potential exposure at the agency's campus in White Oak, Maryland. He chose a remote location and continued working.
"Dr. Hahn has worked every single day of this pandemic, including weekends, holidays and more," the spokesperson said in a statement Tuesday.
ABC News' Katherine Faulders, Anne Flaherty and Jordyn Phelps contributed to this report.