At the first in person PDA/FDA Joint Regulatory Conference since the pandemic began, (held September 12-14 in Washington, DC), it was almost impossible to escape the effect that the pandemic had on everyone attending the meeting, regardless of their affiliation. From the inevitable exclamation from presenters at the podium about how great it was to see so many people in person with unmasked faces for the first time in 2 years, through the impromptu conversations that arose between industry and FDA discussing all of the areas of collaboration foisted upon all stakeholders in order to ensure a continuous supply of medicines for the public, or expressed formally during the “Lunch with the Regulators” session, it was hard not to notice the transformative effect that the Covid 19 public health emergency had on our industry and its regulators.

Not only were industry and FDA collaborating closely within the FDA, Centers that prior to the pandemic didn’t even have consistent (or even vaguely similar) websites were collaborating closely, as the audience was informed during the lunch with the Regulators session. They collaborated both among the Centers, and with the higher levels of the Agency itself, sharing resources and information to achieve FDA’s mission. Inevitably, many processes were streamlined, and efficiencies were realized in communication within the entirety of the FDA. It also forced all stakeholders to be adaptable to what was a very fluid situation, as well as being creative with respect to ensuring continuity of their operations. FDA developed an armament of tools that were deployed during the pandemic such as remote regulatory assessments, and also depended more heavily on areas that were available pre-pandemic but not utilized extensively, such as testing of imported product by Customs and Border Patrol. In addition, every Mutual Recognition Agreement with other regulators was used to their full extent, as regulators depended upon the inspection reports of other trusted authorities for regulatory decision making for pending applications.

When asked what was the most impactful finding that should remain post-pandemic (or as it wanes into endemic, it may be more accurate to say), FDA revealed that companies had become much more transparent with respect to issues that might affect drug supply, giving them details of potential staffing issues (and others) that might impact on their ability to produce product, or the need to switch manufacturing sites of a product due to demand on CMOs which had reduced capacity as a result of being short staffed. FDA greatly appreciated the proactive approach that the industry demonstrated during the pandemic and noted they hoped it continues. I am sure that industry greatly appreciates the regulatory flexibilities demonstrated by FDA in responding to this reduced capacity and need to switch manufacturing sites in this very dynamic environment.

However, it hasn’t been all kumbaya and rainbows and kittens. Carmelo Rosa said that, in 2020, FDAers were averaging 3 hours a night of sleep. Others described switching Centers mid-pandemic, having been pulled into the Office of Compliance due to need, and being unable to get necessary hardware to do their job remotely, which was somewhat difficult to deal with during the intense pressure early in the pandemic. Others from OMPQ revealed that remote regulatory assessments are more resource intensive and draining and require more preparation time than in person inspections, as well as significantly more expensive…and that it is almost impossible to detect data integrity issues with a remote records request (704(a)(4)). Despite this, many of the tools developed during the pandemic are going to be here to stay and will be used largely in targeted assessment as opposed to a surveillance inspection.

Even with all the hardships and difficulties, FDA and industry emerged out of the other side with multiple vaccines and therapeutics to treat Covid-19, and new boosters are being designed to immunize against new variants, all in relatively record time, due to the commitment of both the industry and regulators to their common goal of impacting public health. We are all thankful of the efforts made by all parties, and now know that we can all pull together in a crisis, as we have demonstrated. Kudos to us all!