Some versions of the chloroquine, are approved in the united States. Bayer was not. High-level officials, Dr. Bright’s former agency, known as the Biomedical Advanced Research and Development Authority, or BARDA, have not been enthusiastic about the donation; “in vitro” or test tube, studies have not been promising, they said.
“Not a lot of enthusiasm based on in vitro data,” Robert Johnson, an officer of the agency, wrote in an e-mail 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 which has not been initialled to a clinical benefit.”
Mr. Kadlec and his aides, however, were insistent, the emails show. They wanted to chloroquine gift widely distributed in the framework of a clinical trial which would be sponsored by BARDA, with the National Institutes of Health by providing the ethics panel, known as an “institutional review board” overseeing the trial. At the same time, the technology giant Oracle has been the development of a platform, the White House hoped, could serve as a vehicle for physicians to enter data on the drug.
On 23 March, the F. D. A.’s top lawyer, Stacy Amin, dashed off an urgent email.
“Can we please move forward on BARDA sponsor of chloroquine I. N. D.,” she wrote, referring to a “new drug” application, the documents that accompany a clinical trial. “The president is in the announcement this evening, and I believe that the W. H. would like to set up for tomorrow with the data flow into the Oracle platform,” she added, referring to the White House.
By this time, other companies have given tens of millions of tablets of hydroxychloroquine, approved in the united States and often used to treat lupus, rheumatoid arthritis and other autoimmune diseases, as well as for the prevention of malaria.
But top F. D. A. officials, as well as to Dr. Fauci, has taken a bit of a clinical trial idea — and, in particular, the Oracle platform, which they viewed as impractical, according to three people involved in the decision-making. Dr. Bright, too, was reluctant; if the medication had to be admitted into the national reserve, he wanted their distribution tightly controlled.