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CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On

CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On

Source : 'The Pink Sheet'

Some of the better guidances to come out of the US Food and Drug Administration’s Center for Biologics Evaluation and Research recently were written under coronavirus-related pressure, and director Peter Marks said the lessons could lead to permanent process changes once the pandemic is over.

Among the efficiencies required for the pandemic response has been a much more truncated timeline for some guidance documents. Marks said staff now have what he called “courageous conversations” earlier on because there is less time for multiple meetings, which sometimes stretched the process over several months.

“Instead you just have it out and say ‘Look we gotta get this out. What can you live with? What can’t you live with? Tell me why,’” Marks said during a session of the Biotechnology Innovation Organization digital convention. “That I think has made a big difference because I think paradoxically some of the guidance that we’ve gotten out during this crisis, when I look at it, it’s better guidance. It’s concise. It’s clear. It’s to the point. It contains the scientific information that it needs to, that’s better than guidance we spent months, years getting out.”

“We’re telling people you’ve got to start taking more days off on the weekends because we can’t continue this through the long haul over the coming months.” CBER Director Peter Marks, on sustainability of current response timelines.

Marks said CBER staff realized that quickly written does not necessarily mean poorly written guidance.

“I think that’s clearly something where we shouldn’t be scared of that,” he said. “I think we realize that it maybe isn’t so bad if we streamline how we do it.”

FDA officials have issued more than 50 guidances to help industry develop coronavirus treatments and adapt to the restrictions imposed to prevent the virus’ spread. One of the guidances CBER already released offered recommendations on potential pathways to gaining access to convalescent plasma to treat coronavirus disease. ("US FDA Sets Convalescent Plasma Access Recommendations For Coronavirus Patients" "Pink Sheet" )

Many more are on the way. An updated CBER guidance agenda indicates recommendations on development and licensure of vaccines to prevent coronavirus are planned to be released later this year. The need for such a guidance is growing given that some vaccine candidates are now undergoing clinical testing. ("Moderna Speed Of COVID-19 Vaccine Now Hinges On Enrolling The Right Patients" "Pink Sheet" )

Marks added during a session at the Drug Information Association Global Annual Meeting that guidance development will look different once the pandemic ends.

“From my perspective, if this was over tomorrow and I had to say one thing that I think is going to look very different actually it’s how we develop and get out guidance,” he said.

Marks said that the shorter timelines meant the information in the guidance was fresh, which may make the document more relevant for sponsors than one developed using the slower approach.

“For a lot of what we’re doing, at least in the CBER world, things are evolving so quickly that things that have taken two to three years to develop are often almost outdated by the time they’re published,” he said.

Indeed, much of the speed in guidance writing during the pandemic has related to campaigns to accelerate product and diagnostic development. Whether FDA staff will be willing to work that quickly on non-pandemic issues remains to be seen. Nearly all non-coronavirus guidance development in the Center for Drug Evaluation and Research has stopped. ("Back To Normal US FDA Schedules InPerson Meeting But Pauses NonCOVID Guidance Development" "Pink Sheet" )

President Trump has ordered federal agencies to review the regulatory streamlining measures made because of the pandemic and determine whether any of them could be made permanent. FDA Commissioner Stephen Hahn has asked industry to make suggestions, as well as identify the moves that did not help. ("BIO 2020 Notebook FDAs Hahn On COVID19 Lessons To Be Learned NIHs Fauci On Health Care Disparit" "Pink Sheet" )

One thing that likely will not continue once the agency’s pandemic response ends is the quick response time to sponsor questions and proposals.

For now, FDA is responding to industry inquiries that are directly or partially related to coronavirus in seven to 14 days instead of the usual 30. But those times will not be possible going forward absent significant changes throughout CBER, Marks said.

“That won’t be sustainable unless when we go back for the next user fee agreement we increase our staff by 30% or 40%,” he said during the BIO conference.

Marks added that productivity has increased 20% to 30% since teleworking began, but senior leaders are trying to keep it under control.

“We’re telling people you’ve got to start taking more days off on the weekends because we can’t continue this through the long haul over the coming months,” he said.

CDER Office of New Drugs Director Peter Stein also said during the BIO convention that once there are appropriate coronavirus therapies available and the pandemic is passed, “we will be getting back to timelines that are more manageable and more appropriate.”

By Derrick Gingery