White House officials during the Trump administration pressured U.S. regulators to reauthorize a COVID-19 treatment and not impose certain guidance regarding emergency authorization requirements for COVID-19 vaccines, according to emails published by a House of Representatives panel on Aug. 24.
Officials sent a blitz of messages in 2020 to Dr. Stephen Hahn, the director of the U.S. Food and Drug Administration (FDA) at the time, regarding hydroxychloroquine, including requests to reimplement emergency use authorization for the drug.
Hydroxychloroquine, an anti-malarial, has shown some efficacy as a COVID-19 prophylactic and treatment, but other studies have found it has little or no effect.
Former President Donald Trump promoted the drug, citing a French study that found it was efficacious, and Dr. Deborah Birx, a top White House COVID-19 official, sent messages regarding the study to Hahn, the new report (pdf), from the House Select Subcommittee on the Coronavirus Crisis, shows.
The same day Birx sent one of the emails—March 28, 2020—and told Hahn, “We should talk,” the FDA granted emergency authorization for hydroxychloroquine and a related drug, chloroquine, for treating COVID-19.
The FDA on April 24, 2020, warned about using the drugs outside of hospitals and clinical trials and about two months later, revoked the authorization after several studies indicated the drug did not work against COVID-19.
After the decision, Peter Navarro, a White House trade and manufacturing official, and Dr. Steven Hatfill, a virologist who was helping the White House respond to the COVID-19 pandemic, launched an effort for hydroxychloroquine reauthorization that included drafting a public petition calling on the FDA to reauthorize it.
Navarro asked Hatfill to prepare an EUA request to the FDA, and Hatfill sent a draft of the request to Navarro on June 30, 2020, according to the select committee. Hatfill asked the Henry Ford Health System to submit the request, but to not mention the White House involvement. On July 1, 2020, the health system released a study that showed hydroxychloroquine worked against COVID-19. The system soon asked the FDA to reauthorize the drug for COVID-19 treatment.
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