Convergence: Plenary probes how FDA, EMA will move forward

Regulatory NewsRegulatory News | 12 September 2021 |  By 

During the opening plenary session for RAPS Convergence 2021, leading regulators from the US and EU moved beyond the now-obligatory discussion of lessons learned from the pandemic to a substantive review of how the agencies are really faring a year and a half into the public health emergency of the COVID-19 pandemic.
Speaking to an audience of regulatory experts in attendance at the virtual conference, Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), kicked off the plenary by acknowledging the importance of the deep knowledge held by attendees.
“As the name of this conference indicates, your meeting creates an important and valuable conversation with talented regulatory professionals, scientists and innovators with a direct connection to the development and regulatory processes,” noted Woodcock, emphasizing her confidence that the profession’s “important role in informing and strengthening the regulatory process” would continue to have a positive impact on public health.
“And nothing shows that like what we’ve been through in the past year and a half,” she added.
“One of the rate-limiting steps for some new products has been our inability to perform facility inspections in some locations; some countries have been closed to outside visitors,” conceded Woodcock. Though in many cases records reviews or remote inspections will give the agency the information it needs, “we have been limited in some cases in getting to a final action on a few products because of our inability to get the inspections done that were needed.”
“We will continue staying on top of this problem,” Woodcock added, noting that FDA’s recent resiliency plan includes details of how the agency plans to mop up overdue or missed inspections.
Kim Belsky, executive director of regulatory policy and advertising and promotion at Mallinckrodt Pharmaceuticals and the session’s moderator, followed Woodcock’s presentation with a panel discussion with top FDA and European Medicines Agency (EMA) officials.

The marathon becomes an ultra-marathon
Belsky first asked panelists how they kept their staff engaged and motivated for the duration of a public health emergency that has stretched longer than anyone could have conceived it would when, in March 2020, the US saw its first lockdowns.
“So it has been a marathon, and it has taken its toll,” acknowledged Peter Marks, head of FDA’s Center for Biologics Evaluation and Research (CBER), adding frankly that some staff members have fared better than others.

“And I think what's very motivating here is that we really are making a difference” in terms of US public health, said Marks, whose staff oversee authorization and approval of vaccines as well as monoclonal antibody therapies against COVID-19. Despite challenges and exhaustion, Marks pointed to the resurgence in COVID-19 cases as motivation to press on. “If you look at the last week, we’ve had upwards of 1,500 deaths per day in the United States.”
There may be an early morning hour or two where few CBER staff are logged on and working, said Marks; by and large, he said, the center is continuing to tackle its mountainous workload by working around the clock.
Alexis Nolte, EMA’s head of human medicines, concurred that round-the-clock work has been the norm, but added that the brutal pace will take its toll eventually. “We are now at the stage… where we need to find our ways back to recovering and working more normally,” said Nolte, because such a high level of stress will eventually become unsustainable.
“The workload has just been enormous,” concurred Jeffrey Shuren, head of FDA’s Center for Devices and Radiological Health (CDRH), which has been tasked with authorizing and approving COVID-19 tests as well as masks, respirators, other personal protective equipment, ventilators and more.
About 20% of CDER staff have been fully dedicated to this COVID-19-related work, said Shuren. “And yet all the other non-COVID work has not let up.”
Motivation, said Shuren, is not an issue for his staff: “My colleagues have not only drunk the public health Kool-Aid, they make the Kool-Aid.”
Global information-sharing is here to stay
Belsky also queried the panel about the unprecedented international regulatory cooperation the pandemic has brought forth; the regulators agreed that information-sharing has been key, and ways to keep communication open should persist beyond the pandemic.
“Being able to share pharmacovigilance data in near real-time has been very helpful,” said Marks. Following up on safety signals in a coordinated way has also helped with a global regulatory challenge when it comes to vaccines, he added.
“I think it’s been very helpful for large regulatory agencies like EMA and FDA to be able to help some of our smaller counterparts understand that you can’t get too twitchy with safety.”
“You have to be diligent,” Marks clarified, “but launching new vaccines – I’ve said this before – launching new vaccines is not for the faint of heart. Stuff happens,” including rare adverse events when a vaccine is launched in a large population.
The opportunity that international regulators should not miss the next time around, added Marks, is the chance to find ways to simplify both regulatory submissions and how the submissions are evaluated “to make it easier in the next pandemic.”
Shuren and Marks agreed that early, frequent communication between sponsors and FDA has been key to being able to move at speed during the pandemic. However, maintaining fluid and frequent communication without sacrificing high standards for safety and effectiveness is a labor-intensive proposition, the FDA leaders noted.
“Literally, a developer could work with our scientific and technical experts and clinicians in real-time or near real-time” as the agency picked up its pace during the pandemic, said Shuren. This speedy and interactive process was “a big time- and money-saver for developers, and ultimately great for patients because safe and effective devices were getting developed, evaluated, reviewed and approved far more quickly,” he added.
For EMA, the rolling review process was a novelty, but a successful one, said Nolte. Though some details of the process changed, the review process still relied on the quality of scientific evidence, as always. However, industry must also be willing to be transparent and share information in ways they have not been called on previously to do, he added.
Will we ever go back to the office?
Belsky asked the panel how the pivot to working from home went for their respective centers and agencies, and when – or if – an old “business as usual” model will return.
Staff recruitment and retention will be enhanced by the ongoing ability for FDA staff to work remotely some or most of the time, said Marks. Not only can workers recoup an hour or two a day from not fighting the notorious traffic of the Washington, DC area, but the opportunity for some geographic flexibility may help with the retention of some senior staff who wish to relocate to a retirement destination, and then continue to work for another few years.
All three panelists said the move home went smoothly; Nolte added that many EMA staff were already working remotely as the agency’s headquarters moved to Amsterdam, with a post-Brexit building move also impeding matters.
The all-remote scenario also facilitated ad hoc meetings, but there are still drawbacks when people aren't in the office, Nolte said. “The problem with remote working is, it’s all about efficiency. A working relationship isn’t built just on efficient interactions, but on human interactions.”
RAPS Convergence 2021 Opening Plenary


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