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Regulatory News | 11 September 2022 | By Ferdous Al-Faruque
Convergence 2022 plenary panelists Peirce Clark, Timothy Hsu, and Gary Turner
PHOENIX, AZ – Kicking off RAPS Convergence 2022, top regulatory officials from both sides of the Atlantic warned of political meddling and misinformation that undermines trust in public health and urged attendees to work together to advance regulatory science.
Robert Califf, commissioner of the US Food and Drug Administration (FDA), and Tony Humphreys, head of the European Medicines Agency’s (EMA) task force on regulatory science and innovation, spoke virtually about some of the challenges and opportunities regulators have learned from their response to COVID-19. While they noted that scientists, industry and regulators across the globe came together to develop vaccines, drugs, and diagnostics, they also said they faced unprecedented political interference and misinformation.
Califf noted that the FDA’s mission to ensure products getting to market are safe and effective depends on its ability to generate evidence and go where the science leads regulators.
“It's one of the FDA’s strengths that we go to great lengths to conduct our science and evaluate the evidence for the benefits and risks of products in a manner that's objective and not susceptible to inappropriate pressure from political forces,” said Califf.
However, he said that the agency’s independence has come under threat during the pandemic, citing the recent House Oversight Select Subcommittee report, which highlighted political interference by the Trump administration to push the FDA to authorize vaccines and therapeutics before agency reviewers have had time to properly evaluate them. (RELATED: House report finds Trump officials sought to influence FDA during COVID pandemic, Regulatory Focus 25 August 2022)
“We open the door for political- or financially-driven meddling when we don't have the highest quality evidence for decision-making,” warned Califf. “In fact, I've observed that the controversy generated by our decision-making process is inversely proportional to the quality of the evidence used to make it.”
Califf also spoke about the critical role the FDA plays in giving the public confidence in the products it oversees and lamented the surge of COVID-related misinformation.
“Communicating with the public has been a mainstay of our work throughout the agency's history, from warnings we've provided to the public for various forms of quackery and misrepresentation of purported treatments, to the careful review and approval of new safe and effective treatments, including, for instance, the review and authorization of vaccines and antivirals to treat COVID-19,” said Califf. “Today, however, misinformation and disinformation run rampant. As a result, we're witnessing enormous harm to patients and consumers.”
The commissioner noted the decline in life expectancy in the years, which he said is especially confounding considering the rapid advancements in medicine that should be helping people live longer.
“The reason is clear, people are making plainly adverse and uninformed choices regarding their health… all in the face of definitive facts that not only make clear these actions are not only harmful but also can lead to shorter life expectancy and more debilitating illnesses,” said Califf. “The evidence supporting the safety and effectiveness of [COVID-19] vaccinations and antivirals is among the strongest I've seen in my lifetime, and yet people are being diluted by an ocean of false or distracting information.”
“Like the monster in the TV show Stranger Things, which can weave its way almost anywhere, misinformation spreads on the Internet, in chatrooms and elsewhere, reaches everywhere creating its own ecosystem,” he added. “It's perhaps the greatest challenge we face in public health right now.”
The commissioner noted that the FDA has partnered with the Reagan Udall Foundation to develop strategies to combat misinformation and asked conference attendees to do their part on personal and professional levels to help the agency fight the spread of disinformation. He also asked them to provide input on ways the FDA can improve the current regulatory landscape.
“I would also expect an expert in regulatory affairs to think every day about how to make the rules better: How do we create regulatory pathways that help the industry move into new areas of intervention that will have the greatest impact on health and drive health improvement? How do we optimize the efficiency of the system while maintaining or improving quality?” said Califf. “Your best ideas on how to improve the system could have a significant impact as we think about crafting regulatory policy in the face of opportunity and risk.”
While Califf highlighted many of the unprecedented challenges regulators faced during the pandemic, especially with the spread of misinformation on social media, EMA’s Tony Humphreys noted that social media and communication between researchers across the globe enabled the rapid development of medical countermeasures to SARS-CoV-2.
Humphreys noted that the disease has killed around 6.5 million people around the world and massively disrupted global trade but said the pandemic is a case study of how public health officials and researchers around the world are able to mobilize in the modern era to fight pandemics.
“Frontline doctors and nurses battled to understand the disease as it emerged in 2020, repurposing existing intensive care medicines and evolving treatment paradigms with rapid best practice exchange facilitated by social media communication networks and open science,” said Humphreys. “In parallel, there was an unprecedented collaborative response from academia, developers and government bodies initiating rapid R&D programs to identify the genetic sequencing of the virus and embark on the diagnostic, vaccine and antiviral treatment developments that led to the range of options available to us today and our ability to return to the new normal.”
“The COVID experience is acting like a super catalyst for change in the worldwide regulatory landscape, accelerating the need for more rapid research and developments, rapid regulatory procedures, enhanced safety and effective monitoring, proactive communication, transparency, supply security and harmonized global positions,” he added. “Just as COVID has highlighted that health threats respect no borders and demand global response, so collaboration amongst regulators and developers in creating a regulatory ecosystem to foster innovative healthcare solutions is an imperative if we are truly to succeed in bringing the next generation of healthcare solutions to patients and healthcare professionals.”
Humphreys said that European Union member states have taken lessons from the pandemic to strengthen their crisis preparedness response across borders through EMA and the European Centre for Disease Prevention and Control, while also creating a new Health Emergency Preparedness and Response Authority (HERA). The new agency is meant to facilitate the development, manufacture, and supply of medical countermeasures, and has already been at work dealing with the war in Ukraine and the monkeypox crisis. It is also working on fighting antimicrobial resistance.
Humphreys talked about several recent and ongoing EU initiatives, including EMA’s Regulatory Science Strategy to ’25 to encourage novel manufacturing technologies, and clinical trial designs that use digital data to generate real-world evidence across product lifecycles.
“We believe that investing strategically in these areas through initiatives such as DARWIN EU [Data Analysis and Real World Interrogation Network] and ACT EU [Access to COVID-19 Tools Accelerator] will enable the emerging science and technology being applied across the development pipeline to be successfully translated into access and availability of innovative treatment solutions to patients,” said Humphreys.
“Our selection of these priorities have been validated by the COVID experience with novel manufacturing exemplified by the production of the mRNA vaccines, clinical trials facilitated by the use of remote technologies and rapid generation of real-world evidence to complement limited product approval data sets,” he added. “Whilst these initiatives are progressing, they're very much viewed as a key contribution to evolving the regulatory landscape in Europe.”
‘A Brave New World’
Following Califf and Humphreys’ presentations, Peirce Clark, program development manager at XR Association; Timothy Hsu, director of health technology initiatives at AFDO/RAPS Healthcare Products Collaborative; Gary Turner, managing director for additive manufacturing for Ricoh USA; and Sarah Michel, vice president of Professional Connexity at Velvet Chainsaw Consulting, who moderated the panel, took to the stage to expand on what the future of healthcare will look like.
Clark, Hsu and Turner spoke about their areas of expertise, which include additive manufacturing, artificial intelligence and virtual reality/augmented reality, and touched on how those fields impact patient care today – and they might evolve in the future.
To give attendees an idea of the potential for these new technologies, Clark gave the example of a neurosurgeon who set up a VR/AR program. The hardware and software allow him to take brain scans of patients and create a digital replica that he can then use to digitally see into layers of a patient’s brain anatomy to prepare him for surgery.
“This doctor is equipped with a heads-up display (HUD) in his headset and can see different patient information and procedure information,” he said. “And that same information is broadcast to different displays across the operating room.”
Clark noted that the technology isn’t for just physicians either. Patients are using VR/AR technology in various ways, including for pre-surgical mediative purposes that have been shown to help reduce anxiety and boost their mood, without the need for drugs.
When asked by Michel how the three technologies can be united to change patient care, Hsu noted that the technology in large part is already here. He argued that AI will have a major impact on additive manufacturing and allow physicians to automate the segmentation of the 3D models they create from patient image scans.
"Merging those technologies together will really change the way that we think about personalized patient care, powered with the artificial intelligence that needs to go beyond the analytics behind it, that needs to go beyond running the mathematics,” said Hsu. “And it's mathematics that we [already] have now… right now we’re having a golden period.”
The panelists agreed there still are cost, engineering and regulatory challenges, but working together they have hope that industry, regulators and technology community can find ways to overcome those challenges, especially if they keep talking and collaborating with one another. They noted that stakeholders need to be willing to fail and learn from their failures as technology advances.
To succeed, Turner said, innovators will need to keep an open mind and expand their thinking.
"Think outside of the box, because these technologies are innovative and different and therefore, we have to approach this with an open mind and recognize that this is really a brave new world,” he said.
His takeaway message to attendees was that they need to “be excited” because the technology is coming at a rapid pace, and it will change how medicine is practiced.
“We’re in a new age in healthcare, in precision care, and you have a chance to shape the future of that,” he said.