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Regulatory Focus™ > News Articles > 2021 > 4 > FDA seeks to improve on EUA processes, inspections following PREPP review

FDA seeks to improve on EUA processes, inspections following PREPP review

Posted 02 April 2021 | By Michael Mezher 

FDA seeks to improve on EUA processes, inspections following PREPP review

The US Food and Drug Administration (FDA) on Friday said it will work to improve on five areas of its COVID-19 pandemic response to make the agency more resilient in the current and future public health emergencies.
 
“As we continue our COVID-19 response, it is critical that we learn from both our successes and the challenges we experienced, to best improve our operations,” said Acting FDA Commissioner Janet Woodcock.
 
The five areas cover FDA’s emergency use authorization (EUA) processes, transparency, public communications, inspection capabilities and supply chain oversight. FDA selected these issues from among the many recommendations laid out in the summary report from its Pandemic Recovery and Preparedness Plan (PREPP) initiative. (RELATED: PREPP initiative: FDA’s COVID-19 response and the path forward, Regulatory Focus 15 January 2021).
 
The report, prepared by an independent third party, identified twelve actions FDA could take to improve its emergency response to accelerate its response to the COVID-19 crisis, sustain and scale innovations and enhance future pandemic preparedness.
 
Upon its release, then-FDA Commissioner Stephen Hahn and former Deputy Commissioner for Medical and Scientific Affairs Anand Shah said the report was not a “to do” list and that the agency would need to “carefully consider” which recommendations to implement.
 
Initially, FDA says it will focus on five of the recommendations, which it settled on “after an evaluation of the FDA’s priorities, workload and budget, measured against the demands posed by both the agency’s ongoing pandemic response and our traditional public health responsibilities.”
 
A recent Government Accountability Office (GAO) report on the federal COVID-19 response touches on several of the areas FDA says it plans to improve on, including EUA transparency; inspections planning and alternative tools; and supply chain oversight.
 
For EUAs, FDA says it will begin by reviewing its processes and identifying areas for improvement “to ensure transparency and facilitate appropriate integration of these products including diagnostics, therapeutics and vaccines into medical care.”
 
FDA also commits to evaluating alternative inspection approaches using virtual or video-enabled platforms to facilitate inspections when investigators are unable to go on-site at facilities. (RELATED: Inspections down in 2020, but CDER hit most goal dates, Regulatory Focus 26 January 2021; FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021).
 
FDA’s communications will be subject to review as well, with the goal of providing “timely and accurate communications to the public.” While FDA does not elaborate further, the summary report calls on the agency to “diversify its COVID-19 communications to reach broader and more diverse segments of the population who have been disproportionately impacted by the pandemic.”
 
Lastly, FDA says it will evaluate its supply chain tracking, monitoring and assessment systems with the aim of improving supply chain resilience.
 
FDA

 

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Tags: coronavirus, FDA, PREPP, US

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