Remarks for the Global Pharmaceutical Manufacturing Leadership Forum November 1, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

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Good morning.  I’m delighted to participate in this Global Pharmaceutical Manufacturing Leadership Forum, and I want to thank the International Society for Pharmaceutical Engineering (ISPE) for inviting me.   

The topic I was asked to speak on today – “Lessons Learned from COVID” – underscores the twofold 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.  

This dual strategy is at the core of the FDA’s work and mission.  

It’s been about eight months since the United States became immersed in the public health emergency triggered by the SARS-CoV-2 virus. For many in other parts of the world it’s been even longer.  

In that time, the virus has disrupted families and communities, upended businesses, and caused many personal tragedies.

We have responded by altering behaviors and increasing our understanding of the disease.

Though our understanding of this virus is still far from complete, 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, represent 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 uniquely suited to the role of putting these pieces together.  

As an agency dedicated to the mission of protecting and promoting the public health, we are committed to supporting the research necessary to find answers and to ensure that the public knows what we know about this disease and how we are working to conquer it. 

The 17,000+ FDA employees have demonstrated extraordinary diligence, knowledge, and commitment in their response to this pandemic.  They have worked around-the-clock in an effort that has involved an approximate doubling of the Agency’s workload to solve problems involving some of the most challenging public health issues we’ve faced in over a century.

They’ve helped facilitate alternative testing strategies to address supply shortages, augment increases in personal protective equipment, ventilators, and other essential medical devices; ensure continued access to necessary medical products; counter the sale of fraudulent products; and support the development of therapeutic products and vaccines.

And, even as they have responded to the pandemic, our centers and offices have continued to fulfill the Agency’s regular mission-critical responsibilities, from the approval and clearance of medical devices, to the approval of safe and effective new drugs and biological products, to maintaining our high standards of food safety, and to ensuring our continuing oversight of tobacco products, including e-cigarettes. And that’s just the beginning.

While the SARS-CoV-2 virus poses unprecedented threats and comes with a steep learning curve, it doesn’t mean that we’re starting from scratch.  

An essential strength of the FDA, as I mentioned, is our ability to be proactive in our response to a public emergency.  We are uniquely equipped to respond to a crisis.  

This includes having the necessary tools.  For example, after the terrorist attacks of 9/11, Congress created the Emergency Use Authorization to ensure that potentially lifesaving medical products could be available to people in medical need before they had been fully studied to the same level as approved products. 

Since the start of this emergency, the FDA has responded to the unprecedented demand for diagnostic tests, PPE, and other medical products by authorizing more than 300 Emergency Use Authorizations, otherwise referred to as EUAs, covering more than 600 products. To put this in context, that is more than 10 times the amount of EUAs issued for all previous public health emergencies.  

In short, the ability to respond to a public health emergency is part of the Agency’s DNA.

Our experience includes strategies developed in response to urgent public health needs as wide-ranging as the Ebola Virus, outbreaks from foodborne illnesses, and dangerously tainted medical products.  

And our response is informed by our research, investigation and enforcement mechanisms, strengthening our rulemaking apparatus, and by the application of hard science and rigorous data.

From early on in this crisis, we’ve looked to apply lessons learned from these and other experiences, while also considering how we can further adjust what we are learning now to make us stronger and better equipped to fulfill our responsibilities to the American people.  

One way we’ve sought to support this effort is with the COVID-19 Pandemic Recovery and Preparedness Plan – we call it PREPP – which was launched in June and focuses on identifying avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products. 

Examples can be seen across the FDA’s operations.  

For example, we’ve developed new means of coordination to move new treatments to patients as quickly as possible.  Our Centers for Drug Evaluation and Research (CDER) and our Center for Biologics Evaluation and Research (CBER) initiated the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program that accomplishes this goal while at the same time ensuring that new treatments are helpful, not harmful.   

When CTAP was launched earlier this year, 72 clinical trials of potential therapies for COVID-19 were underway with FDA oversight. As of September 30, 2020, more than 500 drug development programs are in planning stages, more than 350 clinical trials have been reviewed to determine that an Investigational New Drug is safe to proceed, and five COVID-19 drugs are authorized for emergency use. 

We’ve also streamlined many of our processes to make it easier for developers and scientists to send inquiries and requests.  And we are constantly examining these operations to make the FDA more efficient in carrying out our regulatory responsibilities. 

We also have speeded up the availability of guidance documents for industry. To date, the FDA has issued more than 60 COVID-19 related guidance documents and revised many others to provide greater clarity, transparency, and regulatory flexibility on a wide variety of products, from diagnostics to the conduct of clinical trials.  

We’ve accelerated the need for investing in advanced manufacturing to increase access to critical medical products, lowering production costs and decreasing the risk of supply disruption.

Modernizing technologies is also crucial to all-hazards preparedness. It provides a more flexible and agile manufacturing capability in the United States in response to emerging infectious diseases and disease outbreaks.

One way we are facilitating the adoption of advanced manufacturing technologies is by working with international partners on guidelines for continuous manufacturing as part of the International Council for Harmonisation’s Q13 proposal, which will further inform the agency’s policy and guidance on advanced manufacturing. 

We’ve also taken a fresh look at how clinical trials can be designed and conducted.  

Early on in the crisis, the FDA, National Institutes of Health, and industry worked together to facilitate the implementation of a “master protocol” that can be used in multiple clinical trials and that allows for the study of more than one promising new drug for COVID-19 at a time. And we have used expanded access to meet the needs of patients who are not eligible or who are unable to participate in randomized clinical trials. 

We issued guidance to investigators on addressing ways to adapt trials during the pandemic, including recommendations on the use of virtual visits and methods for secure delivery of investigational products. 

And we’ve expanded the data we evaluate in our review of medical products.  

For example, the availability of digital health data holds promise to inform product development for COVID-19.  

Clinical data collected outside of traditional clinical trials—or real-world data—can help accelerate FDA’s understanding of how COVID-19 is affecting patients and help FDA advise product developers on how to optimize the design of clinical trials. 

Moreover, evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate potential shortages. 

These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19.  The more experience we have with real world data, the more confidence we will have in using it for product decisions. 

The COVID-19 Evidence Accelerator, run by the Reagan-Udall Foundation and Friends of Cancer Research—and with robust participation from FDA—has become a great example of how a large group of stakeholders can come together to advance the science of real-world data and its use in responding to the pandemic.

We’re also adapting and constantly evaluating ways to optimize the agency’s inspection program, including studying how we might incorporate new technologies and tools to support our inspections. 

As you know, in March, the FDA postponed on-site domestic and foreign routine surveillance inspections due to concerns around the pandemic, although FDA investigators have continued to conduct mission-critical inspections both domestically and abroad, along with other activities to ensure FDA-regulated industries are meeting applicable FDA requirements. In July, we resumed prioritized domestic surveillance inspections. 

During this interim period, for manufacturing facilities, FDA is expanding the use of other tools and approaches, when possible, that have proven effective to help ensure the quality of drug products imported into the United States. 

These may include physical examinations of products arriving at U.S. borders or product sampling and testing before release into commerce, reviewing the compliance histories of facilities, and using information shared by trusted foreign regulatory partners through mutual recognition and confidentiality agreements. 

The FDA also continues to work with U.S. Customs and Border Protection to target FDA-regulated products intended for importation into the United States that violate applicable legal requirements. 

The FDA has the ability through its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting – we call it PREDICT – import screening tool to focus its examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening has continued to adjust product risk scores as necessary throughout the COVID-19 outbreak.

One final area I want to mention is our work to prevent the distribution of fraudulent products.  

It’s not uncommon to see a new disease accompanied by efforts to exploit consumers through the sale of unproven medical products, often employing fraudulent claims. 

That certainly was the case with COVID-19.  Once it reached the U.S., the FDA received complaints from U.S. consumers about unproven cures, illegitimate test kits, and substandard or counterfeit respirators being offered for sale on the internet, and the agency identified thousands of new “high-risk” internet domain names that were registered in early 2020. 

To proactively identify and neutralize these threats to consumers, the FDA launched Operation Quack Hack in March 2020, to leverage agency expertise and advanced analytics to protect consumers from fraudulent FDA-regulated products during the COVID-19 pandemic. 

To date, the FDA has identified more than 1,100 fraudulent and unproven medical products related to COVID-19. The Operation Quack Hack team has reviewed thousands of websites, social media posts, and online marketplace listings, resulting in over 110 warning letters to sellers, more than 220 reports sent to online marketplaces, and more than 270 abuse complaints sent to domain registrars. 

Operation Quack Hack initiatives have led domain registrars and online marketplaces to review and take down numerous websites or listings illegally selling unproven products. 

What I’ve outlined for your today is just a sampling of some of the ways we are using what we have learned to respond to this and future public health crisis.  I am hopeful that we will be able to look back on these trying days with valuable perspective and useful knowledge from 
lessons learned.  

In closing, I want to underscore one final point about the FDA and our pandemic response.  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 underpinnings of our actions.  

Thank you.