FDA Needs to Regain Public Confidence: Borio
Luciana Borio, who was FDA acting chief scientist and served on the National Security Council in the Trump administration, says FDA needs to work to regain public trust after its missteps involving the emergency use authorization for hydroxychloroquine and chloroquine and allowing unapproved serology tests into the country. Interviewed for a Barron’s commentary on the “complicated” rollout of any potential Covid-19 vaccines, Borio said she was “equally surprised and disappointed to see the initial steps FDA took. The decision early on not to regulate serology tests created a wild west of tests out there that consumers and health providers couldn’t really rely on.”
Asked what FDA’s failures mean for the prospects of a safe, effective, and trusted vaccine to be developed in a very short timeline, Borio said she has great faith in those working on the issue at the National Institute of Allergy and Infectious Diseases and in the FDA Office of Vaccines. She said they “understand their responsibility and the science issues tremendously well. They’re a very strong group. When a vaccine is authorized for use I would hope that it will be based on the opinion of those people.”
But she immediately added that FDA leadership, in general, “needs to do some work to regain confidence. Remember that the vaccine group is different. But given the initial missteps, it will be important for the FDA leadership to work hard to be able to regain the trust of the public.”
Asked if FDA is being unduly influenced politically, Borio said she had seen no evidence of that concerning vaccines. “We don’t want to revisit the hydroxychloroquine issue,” she added, “but it seems to me that there was political influence associated with that issue.”
When asked for comment, an FDA spokesperson referred Barron’s to a recent speech by agency commissioner Stephen Hahn in which he said that “good science as the basis for decision-making has been a hallmark of my career, and is a value that I hold deeply.”
In her remarks not related specifically to FDA, Borio made the points that if there are vaccines available this fall they will not be immediately available to everyone, there is considerable confusion over what treatments work in part because clinical study standards have slipped, and America blindly reacted to China rather than devise its own pandemic strategy.