Former commissioners, Woodcock dissect pandemic response, future challenges at FDA

Regulatory NewsRegulatory News | 17 January 2022 |  By 

A panel of former US Food and Drug Administration (FDA) commissioners, as well as Acting FDA Commissioner Janet Woodcock, addressed the agency’s role in addressing the current and future pandemics, as well as their predictions for FDA’s near-term future.
The commissioners made their observations at the recent UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) Innovations in Regulatory Science Summit.
There was consensus among the panel that a broad set of core capabilities must be developed to deal with a range of potential public health threats in the future, as well as the capacity to quickly ramp up manufacturing of critical countermeasures, such as vaccines, in response to a crisis.
Both Robert Califf, whose nomination to lead FDA for a second time is pending before the Senate, and Mark McClellan, who headed FDA during George W. Bush’s first term, discussed the need to develop platforms and systems to enable research, validation and manufacturing and to enable better use of real-world evidence. (RELATED: Senate committee advances Califf’s nomination as FDA commissioner, Regulatory Focus 13 January 2022)
Margaret Hamburg, who served as FDA commissioner for most of Barack Obama’s two terms, said that the next commissioner should also address “morale and staff burnout” at the agency. Woodcock noted that resource constraints and the heightened workload have put a serious strain on FDA staff. It was further noted that the agency has made much progress over the past two decades in its interactions with the industry.
COVID-19 response
Scott Gottlieb, who served as former President Donald Trump’s first FDA commissioner and departed the agency in 2019, criticized the government’s response to the pandemic, saying that, “One of the challenges we had with this pandemic was that a lot of our planning was very pathogen-specific.”
“We always anticipated that the next pandemic would be caused by a flu … COVID showed that when you prepare for one pathogen you may not have the infrastructure to deal with something else,” he said.
“The bottom line is, we have to go into planning for the future with the mindset that we can’t predict what the pathogen is going to be. Even if we get it right and the next pandemic is caused by a flu – and it probably will be. The virus could present with neurological symptoms or GI symptoms, so the influenza-like illness surveillance system may not be sensitive at detecting it. It could evade our existing antigen and molecular tests for influenza, it could evade the antivirals that we stockpile, it may not be amenable to egg-based manufacturing … so we can’t assume that even if we get the pathogen right, it’s going to have features that allow it to be reached by what we would plan in advance,” Gottlieb said.
His solution: “We need to focus on developing core capabilities – both infrastructure and policy capabilities – that could be amenable against a range of different potential threats and try to identify what the universal needs are.”
Woodcock and others agreed with this assessment but noted progress in some of the areas that posed a challenge at the outset of the pandemic.
“The regulatory agencies worldwide … have really started working together very closely and I have been pushing this a long time for manufacturing so that we can get things moving and we can allow innovation in manufacturing without having 500 different applications. We’ve made a lot of progress,” Woodcock said, noting the increased use of mutual recognition agreements in the inspection space.
Hamburg noted that many of the issues that have been raised as weak points or areas needing improvement during the pandemic have been discussed for years. “I think that we are in a different place than we were 20 years ago, but sadly, there were reports and studies and plans put together decades ago that identified many of the same issues that we’re talking about today, and we kept saying, ‘This is the wake-up call and now we’ll finally put in place the capabilities that we need,’” Hamburg said.
Manufacturing capacity
Manufacturing constraints and the need for “hot bases” of manufacturing to enable surge production, were discussed as well.
“We lack excess biological and vaccine capacity in the US and the question is how to build in new resilience into the system and not just build facilities and mothball them. We need a hot base of manufacturing and be able to do surge production in the event of a crisis,” Gottlieb said.
Hamburg concurred, and said that, “We need hot manufacturing bases, that is critical and will benefit us when the next big one comes along.”
Building up morale
Another issue of concern was how the pandemic has affected FDA staff. Hamburg said that there is a need to address “morale and staff burnout” at the agency, which she called a “huge concern” as it emerges from the COVID-19 pandemic.
Hamburg also brought up resource constraints and called the agency “chronically under-resourced.”
“We need to be able to support a robust FDA employee base. Public confidence and trust is huge … and resources. Sadly, for all of our tenures as commissioner, I think advocacy for FDA and resources it needs has been an important aspect of our job, but now more so than ever,” Hamburg said.
When asked to identify the number one challenge facing the agency, Woodcock agreed with this assessment. She said that, “The agency is getting so resource-constrained, people are besides themselves.”
Interactions with industry and technology
On another front, the former officials said that the agency has made much progress in its interactions with industry.
McClellan said that, “FDA has made a tremendous amount of progress over the last couple of decades in terms of interaction with industry and clarity about what is expected in the regulatory process.”

McClellan also cited the need for FDA to develop systemic and platform-based approaches to validating and evaluating products, including those that can integrate real-world evidence.
Califf added that technology infrastructure can be a major factor in being able to use and act on data. “A difference in getting simple things done inside the FDA versus what I see now is profound, and I know you’re working hard to modernize it,” Califf said. “Unless we fix this fundamental computing infrastructure, people will wonder why some things take a long time. It’s because it’s not being done in the most modern way.”
“You’re singing my song,” Woodcock said, adding that some of the technology FDA uses is “really very, very bad, but I hope we can get that modernized.”
Looking forward
Toward the end of session, Califf was asked to give an optimistic forecast of where the agency will be in three to five years.
He responded that, “Three to five years from now we will have rebuilt the public trust, remembering that mistrust is a growth factor for misinformation, and I think we have to aggressively attack that, and I think we will. I have no worries about technology moving ahead. It is so synergistic right now, and I think that is going to happen.”
Califf added that the panel had not discussed agriculture, which he pointed to as a major contributing factor in chronic disease and declining survival. “A lot of this is driven by what people eat and how they think about what they eat. We have an amazing opportunity there right now to improve what people eat … Five years from now we should have a population that is much more trusting, living in a digital environment that is supported by broadband everywhere, and we’ll be eating better,” he said.
CERSI summit


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