BIO2023: FDA CBER’s Peter Marks on COVID-19 Regulatory Impact


During a panel discussion at the BIO International Convention, Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research (CBER) discussed the positive regulatory outcomes of the COVID-19 pandemic as well as the backlogs it created and the challenges of carrying the lessons learned forward.


At Monday’s panel discussion “Friend or Foe: How COVID-19 Changed the Dynamic with Global Regulatory Agencies,” Marks shared his views on the pandemic’s regulatory impact along with Sabine Haubenreisser, principal scientific administrator within the stakeholders and communications division of the European Medicines Agency and Henrietta Ukwu, executive VP of Novavax.


What I think we have learned in public health emergency is that where there is a will, there can be a way

Peter Marks

Preparedness and positive outcomes

“What I think we have learned in public health emergency is that where there is a will, there can be a way,” said Marks, referring not only to the COVID-19 pandemic, but to other public health crises the agency has confronted. “We had already had a lot of discussions about potential trial designs; we had discussions about what would be necessary for minimum manufacturing in order to have an emergency use authorization, and we had a mindset that was developed during Ebola,” he confirmed.

Marks praised the reactivity that enabled vaccines to be brought forward so quickly during the pandemic. “It was amazing how things could move and what could be overcome. It was remarkably heartening as a regulator,” he said. Moreover, the head of CBER applauded the alignment of regulatory agencies and industry. “We were on the same page, trying to get the vaccine to people sooner,” he claimed. “We were all essentially aligned and the advice we were able to give by having constant contact was incredibly helpful. It would be nice to try to keep it up,” he continued.

Another positive outcome of the COVID-19 pandemic for Marks was the coordinated effort of global regulators. “[The pandemic] did shrink the distance between different global regulators,” he said. “Not just around infectious disease issues, but also around things like rare disease therapies, we are now closer than we were prior to the pandemic.”


Regulatory Backlogs

On the less positive side, Marks regretted that the FDA is still catching up from the backlog in inspections it racked up when it gave precedence to the pandemic. “There were casualties of going at warp speed,” Marks said. “For us at the FDA, we are in the process of just going through the backlog,” he maintained.

If another pandemic were to arise, Marks claimed that a portion of the agency’s staff should remain dedicated to making sure the rest of its work is not neglected. “We did that to an extent but not anywhere near as much as I think we could have during the Covid-19 pandemic,” he said.


Carrying lessons learned into the future

Another concern for Marks is regulators’ ability to retain lessons learned from the COVID-19 pandemic. “I increasingly hope that we memorialise this in playbooks so that it does not rely on individual memory or institutional memory, but [to] actually have a playbook to carry forward for when these things happen in the future,” he asserted.

Resource allocation is, however, an issue. “The real greatest challenge is trying to figure out how much of what we did during the pandemic we can continue to do within our resources, and we are just resource-constrained,” he claimed.

This lack of resources has led the agency to carefully select their allocation and run pilot programmes to test viability. “We have to triage right now and that is one of the reasons why, for instance, in rare diseases we are going to run a warp speed pilot for a select few diseases to see if that really makes a difference.”

For Marks, preparedness for future pandemics is also linked to staying abreast of developments in science. “I think what we are working with more and more is to develop a culture of constant learning so that we are ready for the next things that come along,” he said. “That needs to become something that is part of what we do, but we are trying to make it not just part of what scientists do, but also a part of what the review staff do and the organisation as a whole does,” he added.


Read PharmaBoardroom’s exclusive interview with Peter Marks conducted back in 2020.

Related Content

Latest Report