Was FDA Short-Staffed to Handle the Pandemic?
(Thursday, August 5, 2021)
The FDA has more than 18,000 full time employees and an annual budget of over $6 billion. It is high organized, and its regulators are considered some of the smartest in the World. It can handle challenges, or so it would appear to the lay person. Last year, FDA delayed many of its review activities due to the extra workload from the pandemic related products. We still don’t have an approved vaccine despite three vaccines being granted emergency authorization more than 8 months ago. Any communication with the FDA these days carries the disclaimer that it needs more time to do routine activities as it is overwhelmed by pandemic related tasks. FDA leaders routinely announce re-distribution of resources and personnel to deal with one emergency after the other. While the US government poured resources in the private sector to develop vaccines, drugs and medical devices to manage the pandemic, it seems they did not provide the FDA similar support. May be FDA’s sheer size created an impression with the politicians that FDA can handle the extra workload. It is not easy hiring new talent, and it takes time for new hires to be trained enough to do any job. Hiring and training process also takes away the current staff from the tasks at hand to training new personnel. The process is made harder when everything has to done remotely. So, even if the government had mandated that FDA hire additional personnel to review the additional applications, it is hard to imagine FDA being able to find and get the new personnel ready for the emergency. Other regulatory agencies in the world tapped on external resources such as academic reviewers, contractors, and other resources to help them navigate the emergency. And there were some success stories where the local regulators were able stem the pandemic and keep their populations safe. FDA has no such mechanism, so it had to do what it did; move people around and delay routine tasks where possible. It also used the emergency use authorization extensively to initially allow products with limited information through and then weed-out the bad from the good. The pandemic exposed the limitations of our regulatory systems. It showed that having the most resources in the world, does not make the FDA also faster than the rest of the world.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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