By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein
Note: These answers were compiled during September and October 2020.
At the time I began work on this annual forecast article, a panel of FDA scientists had just steamrolled an EUA (emergency use authorization) for therapeutic plasma as a treatment for COVID-19 infection, apparently at the president’s insistence. The issue was not really about the panel’s reasoning but about the Trump administration injecting politics into the decision. Since then, the administration kept up the pressure on the agency to ensure approval of a COVID-19 vaccine before Election Day, though as of this writing, a pre-election approval does not seem likely. But the issue of political pressure will outlast the election; the barn door is now open for presidents to intervene self-servingly in FDA affairs, whatever the outcome of this political contest. That explains why a chorus of former commissioners, scientists, industry executives, and others has deplored the president’s campaign to compromise the agency’s authority.