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Is the Pandemic Over?
(Thursday, September 22, 2022) This week, President Biden’s statement that the “pandemic is over” created a media storm. Public health experts were split on if the statement was premature or if it is time to move on from the classical definition of the pandemic. From a regulatory point of view, the statement from the President could indicate a significant change in the Covid policies in the immediate future with minimal practical impact on the patients. First, it could mean that the Secretary of the Department of Health and Human Services (DHHS) could be contemplating withdrawing the national health emergency declaration of 2020 for Covid. FDA had already announced earlier that it expects numerous products with Emergency Use Authorizations (EUAs) to apply for full approval under conventional applications. For months, FDA has reduced or stopped accepting new EUAs for Covid related products. However, till the national emergency declaration is active, FDA cannot formally stop the EUA process. The EUA process saps a lot of resources at FDA, and there seems to be little political will in the Congress to keep providing additional resources to the FDA for the EUAs. Second, most of the measures implemented to counter the pandemic have been withdrawn gradually over the months. These include the mask mandates at public places and transportation, the mandatory testing requirements, the travel restrictions, and the social distancing requirements. The majority of the public has clearly moved away from the classical pandemic related measures. Third, several pandemic related work practices have become permanent. Remote work, where feasible, is now permanent for most public and private organizations, including the FDA. The FDA has stopped conducting in-person meetings, almost all in-person interactions, reduced in-person inspections, and started hiring permanent remote employees. These practices will not be affected by the announcement of the pandemic being over. Fourth, for the industry, this could signify that most of the pandemic related resources such as emergency fundings for research and vaccines are not available. New products to prevent, diagnose or treat Covid can still be developed but will need to done using conventional regulatory processes. So, whether we agree with the timeline of the pandemic or not, from a practical point of view, the pandemic, or whatever new term is coined for the Covid infections, is over. Whatever preventive or therapeutic measures are currently available to the patients who still might need them, will most likely not be affected by a change in policy, while the rest of the population who has already moved on, will be unaffected. The President just verbalized what has been universally agreed tacitly; the statement indicates that the government may be moving towards formalizing it. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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