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Is FDA Turning Into a Virtual Organization For Good? It Seems Like It
(Thursday, June 3, 2021) As the pandemic recedes in the US, FDA management seems to be having the same issue practically all managers in the country are facing; do we bring workers back to the offices or keep working remote? It seems FDA is leaning towards keeping it remote. In a public presentation earlier this month, the new Director to CDER, Dr. Patrizia Cavazzoni, touted how remote work has been good for the FDA: FDA has been able to hire more reviewers and chemists owing to the remote work capabilities, attrition has fallen, the morale is high, and FDA reviewers overwhelmingly want to keep working remotely. Working remotely is not new; prior to the pandemic FDA used to allow most of its reviewers up to 2 days each week to work remotely. FDA reviewers used to routinely attend meetings remotely, reviews we conducted seamless irrespective of the reviewers being physically located in the offices in Silver Spring or their home offices. In the last few years, almost all documents submitted to the FDA have moved to the electronic format making it easier for the reviewers to access information from their remote work offices in their homes. Last year simply moved that from working a few days a week to working permanently remotely. Remote work is obviously attractive to workers; you save time on the commute, you stay in the comfort of your home, and you can integrate your work and personal life better. But remote workers lose the rapport they have with their colleagues over time, group projects are harder to manage, there is loss of discipline of office hours as workers end up working at odd hours to integrate their personal tasks with work tasks. The balance of in-office work and remote work is essential for any organization. The long-term effects of remote work on the overall performance of a public health organization like the FDA is not known. Does working remotely also mean that FDA staff would only attend meetings and conferences remotely? How would it affect the personal interactions between FDA and the stakeholders both at the industry and public? What about all the resources committed to build office complexes at White Oak to house FDA reviewers if most of the facilities are never used? More importantly how would the sponsors deal with the new dynamics? The world’s largest and most prestigious regulatory body wants to go virtual. It should not be done without consideration for all the above issues and many more that would come up from these. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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