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FDA Commissioner Hahn: Lessons Learned From COVID-19

FDA Commissioner Hahn: Lessons Learned From COVID-19

FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to the pandemic have been combined with FDA knowledge from prior public health crises to maintain ongoing and safe development and supply of medicines and other medical products.

Stephen Hahn, MD

The topic of lessons learned “underscores the two-fold approach we must embrace in responding to this pandemic: working to overcome the challenges posed by this disease as we encounter them, but also using what we learn to be better prepared for future crises,” Hahn said. “This dual strategy is at the core of the FDA’s work and mission.”

Since the start of the public health emergency in the US last spring, “we’ve responded by altering behaviors and increasing our understanding of the disease,” he said. While the FDA continues to learn about the virus, “we are far more aware of its unique dangers and challenges. That awareness, combined with changes in activity and supplemented by our ongoing research, exploration, and discovery, represents important pieces of the puzzle that we are working to solve to defeat this disease and return to something closer to normalcy.”

The FDA is committed to supporting research and keeping the public informed about what it knows about the disease, which is central to its mission of protecting and promoting public health, Hahn said. He recognized the extraordinary commitment, knowledge, and diligence of the FDA’s more than 17,000 employees to address the crisis while also continuing with their regular mission-critical tasks.

Hahn provided details about some of the many actions the FDA is taking in response to COVID-19 in his presentation including helping to facilitate alternative testing strategies, augment increases in PPE ventilators and other essential medical devices, address supply shortages, ensure continued access to necessary medical products, and support the development of therapeutic products and vaccines.

Although the FDA has faced “unprecedented threats and a steep learning curve” in addressing COVID-19, Hahn emphasized that the agency by no means was starting from scratch when it began to address the crisis. The agency has dealt with crises before and is proactive in responding, he said, adding that the FDA has the necessary tools to do so.

For example, Congress created the Emergency Use Authorization (EUA) after 9-11 for potentially life-saving medical products that could be made available before being fully studied to same level as approved products. This is one area where the FDA has been able to make great strides in the current crisis by responding to unprecedented demand for diagnostic tests, PPE (personal protective equipment), and other medical products. The FDA has authorized more than 300 EUAs covering more than 600 products. Hahn noted that this is more than 10 times the number of EUAs issued in all prior health emergencies.

Some FDA responses to the pandemic

The FDA’s “ability to respond to public health emergencies is part of the agency’s DNA,” Hahn said, including making use of strategies developed from urgent public health needs such as addressing foodborne illness outbreaks, dangerously tainted medical prods, and the Ebola virus.

“Our response is informed by our research, investigation, and enforcement mechanisms, strengthening our rule-making apparatus, and the application of hard science and rigorous data,” he said. The agency is applying knowledge from past events and what has been learned so far from the early days of the COVID-19 pandemic and making further adjustments to make the agency stronger and better equipped to address the pandemic.

The COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) was launched in June. It identifies avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products, Hahn said.

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) initiated the Coronavirus Treatment Acceleration Program (CTAP) earlier this year. The emergency program’s goal is to move new treatments forward quickly for patients while also ensuring treatments are helpful, not harmful.

As of 30 September, Hahn said more than 500 drug development programs were in planning stages, and more than 350 clinical trials had been reviewed to determine if investigational new drugs were safe to proceed. Five COVID-19 drugs have been authorized for emergency use.

The FDA has quickly delivered new and revised guidance documents: more than 60 have been issued to date on COVID and many others have been revised for clarity, transparency, and regulatory flexibility on a wide variety of products, Hahn said. In addition, the FDA has streamlined many processes and procedures to make it easier for developers and scientists to send inquiries and requests, with constant reevaluation of operations for increased efficiency.

There is an accelerated need for investment in advanced manufacturing processes, Hahn said, to increase access to critical medical products, lowering production costs and decreasing the risk of supply disruptions. Modernizing technologies is also crucial to all preparedness for hazards. This provides more flexible and agile manufacturing capabilities in the US in response to emerging infectious diseases and disease outbreaks, he explained.

One way the FDA is facilitating adoption of advanced manufacturing is working with international partners on the development of ICH Q13, which will address guidelines for continuous manufacturing.

The FDA also took a fresh look at how clinical trials can be designed and conducted. Early in the pandemic, the FDA, National Institutes for Health (NIH), and industry worked together to facilitate the implementation of a master protocol that can be used in multiple clinical trials so that multiple drugs for COVID-19 could be considered during the same time period. The FDA issued guidance to investigators on how to adapt clinical trials during the pandemic, including recommendations on the use of virtual visits and methods for secure delivery of investigational products.

Expanded data evaluated in the review of medical products is another area the FDA is addressing. The availability of digital health data holds promise for this purpose, Hahn said. This data, also known as real-world data, is collected outside of traditional clinical trials and has the potential to provide rapid, actionable information to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate medical shortages. It could also inform ongoing work to evaluate potential therapies, vaccines, and diagnostics for COVID-19.

A great example of multiple stakeholders collaborating to advance the science of real-world data and its use in pandemics, Hahn said, is the COVID-19 Evidence Accelerator run by the Reagan-Udall Foundation and Friends of Cancer Research, which is receiving “robust support” from the FDA, he said.

The agency is also adapting and evaluating its inspections program, including considering how it might incorporate new technologies and tools to support inspections, Hahn said. In March, the FDA postponed onsite foreign routine inspections, although mission-critical inspections continued. In July, prioritized domestic surveillance inspections resumed. Expansion of other tools and approaches where possible to assess imported products may include compliance history of facilities, physical inspection on arrival at borders, testing, and using information from MRAs (mutual recognition agreements) with other countries.

The FDA is also using Predictive Risk- based Evaluation for Dynamic Import Compliance Targeting (PREDICT), its risk-based analytics tool to electronically screen all regulated shipments imported or offered for import, and continues to adjust risk scores applied during the COVID-19 outbreak as necessary.

The FDA launched Operation Quack Hack in March to address fraudulent efforts to exploit consumers with products related to COVID-19 such as unproven cures, illegal test kits, and substandard respirators. To date, he said that this initiative has identified over 1,100 fraudulent and unproven medical products; reviewed thousands of web sites, social media posts, and online marketplace listings; sent over 110 warning letters to sellers; sent more than 220 reports to online marketplaces; and made more than 270 abuse complaints to domains. Domain registrars and marketplaces have reviewed and taken down products as a result of these actions.

In closing, Hahn said, “in culling the knowledge we have learned from this and previous public health crises, one aspect of the FDA’s work always remains constant: our unwavering commitment to good science and rigorous data. It is essential that the American public and the world have complete confidence in the products we regulate. Speed in reviewing them is important—but so are safety, accuracy, and effectiveness. We will continue to search for answers, develop strategies and solutions, and apply lessons learned to future actions. And in every case, facts and data will provide the underpinning of our actions.”

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