This archive report was first published on 17 June 2020.
On March 23, 2020, the FDA's top lawyer, Stacy Amin, sent an urgent email, urging the agency to move forward with a clinical trial for chloroquine, a drug that was not approved in the United States at the time.
The email was in response to the White House's request to set up a clinical trial for the drug, which was being donated by various companies, including Bayer. However, top officials at the Biomedical Advanced Research and Development Authority (BARDA) were not enthusiastic about the donation, citing 'in vitro' studies that were not promising.
“Not a lot of enthusiasm based on just vitro data,” Robert Johnson, an agency official, wrote in an email to a top aide to Dr. Robert Kadlec, the assistant secretary of health for preparedness and response. “Chloroquine has been shown to have in vitro effects on other microbes, but that has not panned out to clinical benefit.”
Despite the reservations, Dr. Kadlec and his aides were insistent on moving forward with the clinical trial, which would be sponsored by BARDA and overseen by the National Institutes of Health. The White House also hoped to use Oracle's platform to collect data on the drug's effectiveness.
However, top FDA officials, including Dr. Fauci, took a dim view of the clinical trial idea and the Oracle platform, which they viewed as unworkable. Dr. Bright, the former head of BARDA, also expressed concerns about the distribution of the drugs, wanting it to be tightly controlled.
