Regulatory Focus - Expected mistakes, the need for speed, and change to come: Marks looks ahead

Kari Oakes | November 09, 2020

The US Food and Drug Administration’s (FDA’s) Peter Marks, MD, directs the agency’s Center for Biologics Evaluation and Research (CBER). In a wide-ranging 6 November discussion with the president and chief executive officer of the Friends of Cancer Research, Jeff Allen, PhD, Marks spoke to tempering public expectation, sustaining CBER staff despite a crushing workload during the coronavirus pandemic, and the possibility of more changes in 2021.
 
Under a new administration, said Marks, speaking at a virtual session of BioPharma Congress 2020, much could change. “So my hope is that we've already started the foundation for what needs to happen here.  
 
"We need to fundamentally change the discourse here from one of distrust and suspicion to one of confidence that there is a group of individuals who are science-based, who are public health professionals, who are going to make it their business to make sure that whatever comes through this process is safe and effective -- and is something that everyone should feel comfortable taking,” said Marks. “That doesn't mean that we can't make mistakes, but it means that we will put the best minds together” to do the best work with assets on hand.
 
Allen asked how Marks felt about becoming a more public figure: “Peter Marks is becoming a household name for many Americans!” In response, Marks said he’s a person who’s ordinarily very happy to stay out of the limelight. Right now, though, he said that it’s his job to “combat the fear… and the lack of confidence in vaccine development.  ...There needs to be a face of this – somebody that’s going to be reasonable, and somebody that isn’t Pollyanna.”
 
Public messaging, said Marks, needs to be realistic about the fact that vaccines will have some side effects but that widespread adoption of a COVID-19 vaccine will “save many, many more lives.”
 
“I think what we need,” said Marks, is for individuals to be “comfortable rolling up their sleeve and taking the vaccine.” He himself, he said, is not worried about having efficacious vaccines, though some vaccine candidates will likely fall by the wayside. “I’m sure we should expect that some vaccines…probably should not be further developed.” Still, he said, “It’s going to be a development pathway like we normally see, and I’m confident that we’re going to have different efficacious vaccines. I’m also pretty confident that we’re going to have some failure.”
 
Seeing these failures, he said, is just an example of good drug development at work. Early toxicity signals, he said, will be attended to both by sponsors and by FDA, “given the robust interaction between the agency and sponsor professionals.”
 
All of the coordination to move vaccines along, together with CBER’s other work, has placed considerable “wear and tear” on CBER staff, acknowledged Allen. “We’ve been very lucky to have an incredibly devoted workforce – people have been putting in long hours,” said Marks.
 
Staff will be shuffled around to handle vaccine emergency use authorizations as they begin to come in, he said. “I think we have a large bolus of work that we’re looking at in the coming couple of months – and I think we have an all-hands-on-deck approach here where people will be moved around as needed to address that,” said Marks, pointing out that the necessity for speedy regulatory action is why the EUA is an appropriate means of getting vaccines out the door and delivered to Americans.
 
From CBER’s perspective, the increased attention on the agency’s work has had the unanticipated – but welcome – side effect that “people realize that it’s a pretty exciting place to work,” said Marks. He said hiring has been going “a little bit better,” and that the agency has been seeing an influx of resumes and inquiries for available positions.

 

https://www.raps.org/news-and-articles/news-articles/2020/11/expected-m…