Details: Gilead shipped a batch of its investigational drug, called Remdesivir, to China after requesting — but not receiving — federal approval from the Department of Health and Human Services, which is required by law.
Gilead’s unilateral decision to ship the coronavirus drug without approval caused consternation within the senior ranks of the Trump administration, according to administration officials with direct knowledge of the events that unfolded behind the scenes.
The other side: Some officials within the administration think that HHS should have approached the situation with more urgency and coordination, although HHS provided Axios with a timeline that includes three separate instances of the Food and Drug Administration communicating with Gilead.
The company also reached out to senior HHS officials outside of the FDA. “At that time FDA was already actively working on this,” an HHS spokesperson said.
“The timeline normally might be fine, but in a global public health challenge, people need to move, which apparently Gilead was doing and the HHS bureaucracy was not,” said an administration official.