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Crossed lines and poor communication between the U.S. government and a leading pharmaceutical company appear to have complicated the breakneck search for a coronavirus treatment.
Why it matters: Pharmaceutical giant Gilead, in its a rush to begin clinical trials on a potential treatment, may have violated federal law instead of waiting for slow-to-come federal approvals on drug exports.
The big picture: The rules and protocols for these trials aren’t mere bureaucracy — they exist to make sure clinical trials are rigorous, controlled and scientifically sound enough to form the basis of what can be life-or-death decisions.
- At the same time, some officials argue, the federal government needs to be prepared to move especially quickly during emergencies like this outbreak.
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.
Gilead ultimately made this controversial shipment on Feb. 3 — a window in which airlines were quickly shutting down flights to and from China while the virus rapidly spread, making the company believe it needed to move fast.
- Jan. 26: Gilead notified the FDA about its export request, according to a spokesperson for HHS. On the same day, the FDA informed the company of the regulatory requirements and offered to discuss them by phone.
- Jan. 30: The FDA received documentation from Gilead. After evaluating the documentation late into the night, the FDA found it insufficient.
- On Jan. 31, the FDA told Gilead what additional paperwork was needed.
- Feb. 1: Gilead submitted additional paperwork. The FDA emailed the company confirmation that the paperwork was helpful and asked it to send any additional information.
- Feb. 2: Gilead submitted more documentation.
- Feb. 3: “Just minutes before a morning meeting” within HHS to discuss the export authorization, Gilead told HHS by phone that the drugs were already on a plane to China, according to the HHS spokesperson.
- Feb. 7: HHS authorized a second shipment of Remdesivir to China. “At this point, FDA had worked with Gilead to ensure the clinical trial protocols were sufficient to yield data that could potentially support an approval,” the HHS spokesperson said.
What they’re saying: “We believe our limited shipments of Remdesivir to China were made in compliance with all applicable laws, including U.S. laws,” Gilead said in a statement to Axios.
- “In light of the seriousness of this global crisis, we moved quickly to provide the drug so it can be tested through scientifically rigorous clinical trials in China. China at the time was the only country with enough confirmed cases to conduct clinical trials to determine the safety and efficacy of Remdesivir,” the company added.
“HHS was not opposed to sending Remdesivir to China for the purpose of conducting clinical trials,” the HHS spokesperson said in a statement to Axios. “We were concerned with ensuring the clinical trials conducted in China were set up in a way to produce data that would be useful to the U.S. and countries around the world to produce an authorized therapeutic for COVID-19.”