Part 4/8:
The Consequences of Understaffing
Califf emphasized the inherent risks associated with inadequate regulatory oversight. The FDA's role is not merely bureaucratic but essential, as it ensures the safety and efficacy of medical products and responds nimbly to public health emergencies. Each department within the FDA is mandated by Congress to handle public health issues. Therefore, widespread staffing cuts—particularly 700 positions—jeopardize the fundamental protections that the FDA provides.
He illustrated this point by referring to San Francisco Bay Area startups, which thrive in a culture of agility and quick decision-making. While such an approach works for tech startups, the stakes are far higher in public health, where flawed decisions can lead to irreparable harm.