Woodcock: COVID-19 Pandemic Is Not The Time For Structural Changes At US FDA
Executive Summary
Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.
Acting US Food and Drug Administration Commissioner Janet Woodcock cautioned against implementing disruptive changes at the agency now due to the ongoing COVID-19 pandemic that continues to leave the agency's staff stressed and overworked.
Woodcock, speaking on 14 April to the Alliance for a Stronger FDA, was asked about the agency’s interest in establishing other “Centers of Excellence” like its Oncology Center of Excellence (OCE). Created in 2017 under the 21st Century Cures Act, the OCE brings together experts across FDA’s product centers to expedite review of drugs, biologics and devices for cancer and has been widely popularly and successful. (Also see "Keytruda And FDA’s Oncology Center of Excellence: The Regulatory Milestones Keep Coming" - Pink Sheet, 1 Jul, 2020.)
FDA is talking and thinking about developing other excellence centers to take advantage of the “convergence across different commodity areas,” Woodcock said, but emphasized this is not the time for agency restructuring.
“The agency right now is under so much stress. These major or even minor structural reorganizations take a couple of years to get in place and then you have to socialize them and make sure everyone plays together well and learns to work within the new systems,” Woodcock said. “So the last thing I think we need to do right now – our people are tired and they …. have a wall of work in front of us that has to be gotten through – is to do a lot of very disruptive things.”
There are “pluses,” to Centers of Excellence, Woodcock acknowledged. “It’s simply we don’t want to do it in a way that breaks things. And we don’t want to ask exhausted staff members to take some additional initiative on right now.”
Woodcock also warned that OCE’s success might be hard to replicate due to some unique circumstances surrounding that center, such as Rick Pazdur’s relationship as a leader in both OCE and in the Center for Drug Evaluation and Research’s Office of Hematology and Oncology Products.
Woodcock offered a similar assessment of the agency’s ability to begin implementing recommendations made in the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) which was commissioned to help the agency improve responses to future emergencies. (Also see "A Visual Guide To How FDA Can Manage The Pandemic" - Pink Sheet, 18 Jan, 2021.)
When asked how the agency envisions making changes to the clinical trials system based on the report, she said, “We can’t do all those recommendations in the PREPP report right now. We’re still in the middle of a pandemic, and we have to recover. So we will obviously be incorporating some of those things as we go. But some of them will require more broad public input and discussion before we make them an instantiated practice going forward.”
FDA has said it will initially focus on a few key areas from the PREPP report:
- Identifying ways to improve its EUA review process,
- Identifying ways to improve its science-based communications to the public,
- Identifying ways it can improve its inspectional reach by using next-generation technologies such as virtual and video platforms, and
- Identifying potential gaps in the medical product supply chain by evaluating the agency’s tracking, monitoring and assessment abilities.
As for how it continues to deal with the crisis at hand, Woodcock outlined some of the ways FDA will be spending the $500m Congress gave the agency through the Coronavirus Aid, Relief and Economic Security (CARES) Act in March. (Also see "US FDA COVID Funds Move Forward In Congress, No Strings Attached" - Pink Sheet, 11 Feb, 2021.)
Premarket surveillance will take up a “significant” amount of the resources, Woodcock said, emphasizing that emergency use authorizations which, have been used to clear the vast amount of drugs and vaccines for COVID, are technically considered premarket products and require constant surveillance. Notably, COVID-19 variants have impacted therapeutic and diagnostic EUAs, Woodcock said, and FDA is monitoring the vaccines and preparing for any changes that may be needed to be made due to virus variants.
Funds will also go toward supply chain issues in particular advanced manufacturing that can be quickly surged for vaccine production, Woodcock said.
“The pandemic made clear we don’t have enough money and insight and visibility into various supply chains,” she said.
Finally, she said that some of the money will go to “recovery” – work that had to be put off due to the pandemic such as inspections. (See sidebar for related story.)
Agency Still Flexible
Woodcock also weighed in on non-COVID trends at FDA. When asked whether some recently delayed drug approval decisions and reexamination of some accelerated approval decisions is a sign that FDA is becoming more stringent and is less willing to be flexible, Woodcock said no. (Also see "Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors" - Pink Sheet, 11 Mar, 2021.)
“I wouldn’t read too much into the tea leaves over this,” Woodcock said.
She said the “willingness or boldness” that led to HIV medicines and the accelerated approval pathway is not going away, but that it is “is predicated on the idea that the need is so great you are willing to take those kind of chances.”
This article previously was published by Informa Pharma's Pink Sheet newsletter.