When will the Pandemic End and will FDA Ever Go Back to 2019 Practices?
(Thursday, March 24, 2022)
Although many of the pandemic related restrictions are easing across the country and many part of the World, it does not seem that the government will be ready to formally declare that the pandemic emergency is over and many of the practices implemented during the emergency would likely stay for good. While the start of the pandemic is a clearly defined event, the end of the same is not. Although the infection rates and the number of seriously sick patients have dropped, there is also news of new variants of the virus and several parts of the world with varying levels of vaccination and incidence rates. From FDA point of view certain practices are here to stay. First, FDA will increasingly depend on remote inspections and alternate ways to assure compliance. The risk-based approach for on-site inspections where sites meeting a higher risk rating by FDA were visited in person will continue. Similarly, FDA will increasingly rely on alternate sources for verifying the compliance of foreign manufacturers. This should lead to delays for the approval of applications dependent on new manufacturing sites. Second, FDA meetings will stay virtual. Gone are the days of numerous meetings between industry and FDA at the FDA campus in Maryland and in-person Advisory Committee meetings. The virtual meeting platform was popular with FDA staff, and it seems hard for FDA to move back to in-person meetings. Absent a strong protest from the public or industry to bring back the optics of the in-person meeting, it seems we will be meeting FDA virtually only for almost all the meetings. Third, FDA used EUAs to allow several products in the market on an expedited manner and it worked. Most products allowed by FDA were safe and useful for the pandemic. Products, particularly medical devices such as personal protective equipment and rapid diagnostic tests, digital health tools and remote patient monitoring should continue being expedited. FDA seems open to that. Fourth, the clinical trial enterprise has curtained changed for good. Remote monitoring, patient follow-up, electronic documentation, and fewer patient visits are now embedded in the clinical trial practice over the last 2 years and will stay that way. There are certainly other ways things are never going to 2019 practices. Can you list a few to add to the above?
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC