Would An Independent Analysis Of US FDA's Pandemic Response Find Transformative Effect?

Would An Independent Analysis Of US FDA's Pandemic Response Find Transformative Effect?

Source : 'HBW Insight'

A former US Food and Drug Administration commissioner, Andrew von Eschenbach, suggests an external group may offer the best chance for the agency to determine the best lessons learned by lessons from the coronavirus pandemic.

During an 18 May Food and Drug Law Institute Annual Conference session, von Eschenbach, president of Samaritan Health Initiatives, said the agency should use its coronavirus response to enhance its efficiency and communications. An outside group could add to the internal analysis that already is ongoing “sort of like maybe a commission, that really helps examine how this pandemic could change the agency in a very positive way going forward where it gets more efficiency, more streamlined, more effective and more rapid ways of being able to assess products without sacrificing the rigor and the discipline,” he said.

Former Commissioner Stephen Hahn initiated the internal after-action analysis in 2020, near the height of the pandemic and the FDA’s work to alleviate it. The agency hired McKinsey & Company to help prepare its COVID-19 Pandemic Recovery and Preparedness Plan (PREPP), and a Pink Sheet/2021/01/FDA COVID-19 PREPP Initiative Summary Report.pdf">summary report released in January contained wide-ranging recommendations:














But von Eschenbach’s push for an even more thorough post-mortem underscores how many in and out of government hope the pandemic will have a transformative effect across a wide range of areas. 

Acting Commissioner Janet Woodcock also recently said that the COVID-19 therapeutics development groups, which had been part of Operation Warp Speed, conducted an exercise with multiple federal agencies looking at lessons learned to streamline the process and improve evidence generation. The recommendations from the exercise have not been released.

During her keynote remarks to open the three-day conference, Woodcock noted the FDA’s work in the consumer health space near the top of a long list of topics to discuss  about its response to the pandemic makes (see related story).


Von Eschenbach added that if he were a member of the commission, he would explore whether the FDA could continue the type of engagement that was employed with industry and stakeholders to develop vaccines and treatments.

“I think one of the things that was apparent was how well the agency worked with external partners and if that could be examined and analyzed in a way of how could we enhance that so communication between the producers as well as the regulators was going hand-in-hand could be one of those opportunities for process improvement,” he said.

FDA officials worked closely with vaccine and therapeutic developers in order to ensure products were available as soon as possible. Vaccine candidates received real-time review, meaning assessors began looking at data as it was ready, rather than waiting for the entire submission package. ()

Former Commissioner Mark McClellan, now director of the Duke-Margolis Center for Health Policy, also raised criticisms of the clinical trial process. He said a lot of time was wasted conducting trials for potential COVID-19 treatments that did not produce actionable information because they were underpowered.

“I think there is a more systematic approach that we could bring to bear on having an intentional strategy like what we did that worked for vaccines for a range of other therapeutics,” he said. “We didn’t really have that in place and it’s definitely doable with today’s clinical trial digital technologies.”

Woodcock also has criticized the clinical trial system for its inefficiency during the pandemic, saying not only that many trials did not answer important questions, but also that many patients could not participate. ()

Sponsors want to use the upcoming user fee program reauthorizations to codify some pandemic-inspired innovations at the FDA (), including expanded use of real-time review. ()

Remote patient evaluation, which became a staple of the pandemic to sustain many clinical trials when visits were not possible due to travel and safety restrictions, and real-world evidence innovations also should be maintained. ()

One of the highlights of the pandemic for sponsors was the speed that the FDA moved to make decisions on COVID-19 therapeutics and vaccines. Timelines were cut from months to weeks in many cases.

But former Commissioner Robert Califf said that speed likely will not continue once the pandemic is over.

“I never had any doubt the FDA could move more quickly than the timelines if there was an emergency,” Califf, now head of clinical policy and strategy for
Verily and Google Health, said during the conference. “It’s always a possibility for shifting priorities and moving faster on some things than others when there’s a special case, but I don’t see the timelines radically shifting or really shifting hardly at all in fact.”

Von Eschenbach noted that the FDA staff was working around the clock during the pandemic, which is not sustainable.

Multiple agency officials also have said that such a pace was not possible long-term. At one point, senior officials had to tell employees to take more weekends off to avoid burnout. ()


This article previously was published by Informa Pharma Intelligence's Pink Sheet newsletter.