In a time when the FDA needs its best and brightest people onboard, nearly half the senior leadership at the agency will be eligible for retirement by Sept. 30.
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
In the words of former FDA Commissioner Scott Gottlieb, the five-week government shutdown that ended Jan. 25 was "the most difficult operational challenge we have faced in modern times." While the full impact of that challenge could ripple through the FDA for a while, it made little difference in the number of warning letters the agency sent out between Dec. 23 and Jan. 25.
