- Speech by
Food and Drug Law Institute (FDLI) Annual Conference, October 6, 2020
Good evening! Thank you for inviting me to speak at this year’s conference. It is my honor to represent ORA as Associate Commissioner for Regulatory Affairs, a position that I assumed this past April.
I want to thank the Food Drug and Law Institute for hosting this conference each year, as it provides a wonderful platform for people throughout the federal government, academia, industry, and non-profits, as well as consumer and patient advocates, to share important and emerging information about critical and essential products. Together, we can leverage our perspectives to most effectively protect Americans and ensure they have access to new and longstanding commodities that are safe and of good quality. And in this moment, our collective efforts to innovate by employing different strategies are of great importance.
As most of you know, the Office of Regulatory Affairs, or ORA, is FDA’s lead office for all regulatory field activities. We are responsible for a wide range of mission-critical work, including inspections, investigations, sample collection and analyses, examination of imported products, recalls, and enforcement.
Nearly 5,000 ORA staff work in locations across the country and around the globe.
We live in a complex and unpredictable world. It’s not always easy to predict what will hit us next, and when – which is why we must be ready to leverage our resources to respond rapidly and nimbly to emergencies.
The COVID-19 pandemic is a paradigm-shifting public health event that requires an all-hands-on-deck approach.
I am proud to lead an exceptional group of people in ORA. They are committed, dedicated professionals who follow the science and data to inform our operations. The quality of the work they do every day helps us make informed decisions on the products we regulate.
I’m particularly proud of the way ORA staff have risen to the challenges of the COVID-19 pandemic. Our investigators have continued to conduct mission-critical inspections and respond to outbreaks, natural disasters, and other public health emergencies involving FDA-regulated products.
Our team in India worked hundreds of hours to help repatriate Americans over seven weeks as that country implemented shutdown mandates. Our consumer safety officers at ports of entry continue to examine imported products, and our laboratory scientists and professionals adapted to schedule shifts to achieve social distancing while analyzing product samples to ensure the sampled products were safe for consumers.
These are just a few of the ways that ORA staff have met the moment during these challenging times.
Protecting the security of the medical product and food supply chain is always on the forefront of our minds. One of the ways we do this is by conducting inspections and investigations to ensure that products are safe and effective.
In March of 2020, we postponed on-site domestic and foreign routine surveillance inspections due to concerns around the pandemic. As I mentioned, our 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.
These inspections are evaluated using specific criteria on a case-by-case basis and conducted with appropriate safety measures in place. Since March, we have conducted more than 200 mission-critical inspections, including:
- Inspections of facilities for which there is a drug shortage;
- Inspections needed for the approval of novel drugs or drugs related to the potential treatment of COVID-19;
- Bioresearch monitoring inspections to determine the reliability of data submitted in support of premarket and pre-license applications, as well as to ensure the rights and safety of research subjects are protected;
- Inspections as a follow-up to a report of undeclared allergens that led to a food recall; and
- To collect environmental samples in response to foodborne illness outbreaks.
In July, we resumed prioritized domestic surveillance inspections. To determine when and where it is safest for our staff to conduct inspections, the FDA developed the COVID-19 Advisory Rating system, which uses real-time data to assess the number of COVID-19 cases in a local area based on state and national data.
This is an unprecedented time; we are learning as we are going through the pandemic and identifying how we can get our staff out to the venues where they need to conduct activities in the safest way possible for all parties. With the advisory levels, we are trying to not only protect our staff, but also the employees of the facilities we regulate, as well as to comport to public health practices that help ensure that we are flattening the curve.
We have also determined that, for the foreseeable future, that in general, prioritized domestic inspections will be pre-announced to FDA-regulated industry. This will help ensure the safety of FDA employees participating in inspectional activities and the firm’s employees, providing the safest possible environment. Additionally, we are providing our investigators with appropriate personal protective equipment, and additional equipment necessary to carry out inspections. Our investigators will adhere to state and local guidance, as well as applicable CDC guidance, while conducting inspections.
In the spirit of learning from our experiences during this public health emergency, we are evaluating how we can optimize our operations to ensure we are using our finite resources to the best effect possible. We are studying how we might incorporate new technologies and tools to support our inspections, including exploring a pilot to assess use of live or recorded video. Recently, we were able to test the use of live video on two produce farm investigations to facilitate live technical assistance from our headquarters to help with sample targeting.
As we learn more from the pilot, and decide how and when we might use these and other technologies, we commit to having transparent dialogues with regulated industry as to how this may affect our procedures in the future.
Although inspections are critical, they are one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products.
Safety and quality must be part of a firm’s daily routine for their products to be suitable for the U.S. consumer. Communication is also of utmost importance. We remain in consistent contact with our domestic and foreign regulatory counterparts to identify emerging risks in the medical products and food supply systems.
Except for some mission-critical assignments, we are currently not able to physically inspect most foreign-produced FDA-regulated products in the manufacturing environment. To overcome this challenge, we are employing additional tools that have proven effective in the past. These tools conducting examinations and product sampling and testing at our borders, reviewing a firm’s previous compliance history, and using information shared from foreign governments.
ORA is also using FDA’s authority under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act to request records in advance or in lieu of inspections of establishments that manufacture drugs. And we are using establishment inspection reports from capable foreign regulatory authorities under the Pharmaceutical Annex to the US/EU Mutual Recognition Agreement. These approaches help inform decisions related to drug approvals and shortages.
In addition to these records requests, ORA is exploring the use of a remote regulatory assessment program, and we hope to work with industry to use this approach for programs where the 704(a)(4) records request authority does not explicitly apply.
This new approach would involve a remote review of records that a firm is required to maintain for the FDA’s review. The remote review could be used to help determine whether a firm complies with regulatory requirements. In general, the information obtained from such remote review could inform further follow-up by the FDA, and may allow us to focus and limit time needed on an onsite inspection or advance the inspection to a later date.
Our Foreign Supplier Verification Program, or FSVP, is critical to ensuring the safety of food from foreign suppliers. In March of this year, we started using remote FSVP Assessment Protocols to conduct inspections and have found them to be effective at ensuring compliance with the new importer requirements under the Food Safety and Modernization Act, or FSMA. This has helped FDA ensure imported food is safe for distribution, even during the pandemic.
To prepare and educate our external stakeholders on our remote FSVP inspection approach, we released a constituent update in April and have provided multiple outreach events to industry.
In August, we released an FDA fact sheet to help familiarize industry with the FSVP inspection process for both on-site and remote inspections. Since March, we have conducted nearly 700 inspections using the remote FSVP inspection protocol, with almost 100 of these reflecting FSVP inspections of importers from foreign suppliers whose FDA inspection was postponed. Additionally, about a dozen of the FSVP warning letters we’ve issued since 2019 have been due to the findings of a remote FSVP inspection. This demonstrates that FSVP remote inspections have been effective in identifying and preventing the distribution of products that are offered for import without adequate supplier verification and ultimately protecting the public health.
The COVID-19 pandemic has highlighted the interconnected global manufacturing and supply chains of critical drugs and biologics. To better respond to future public health emergencies and to remain nimble to address the changing landscape of industry, human capital, and other external forces, we are conducting an analysis of our inspection process.
This will collect and evaluate information through internal and external stakeholder engagement to identify opportunities for process enhancements and improvements and provide new ways to optimize inspectional work. We anticipate an interim report by the end of 2020 and a final report next summer.
The pandemic has also changed the way consumers behave and the way the industry operates, and, as a result, we’ve taken multiple steps to adapt to this new environment. The New Era for Smarter Food Safety Blueprint that the FDA announced in July of 2020 outlines how we intend to strengthen our approach to the safety and security of our food supply – not only under normal circumstances but also in times of crisis.
New Era builds on what we’re already doing under FSMA. Our approach will not change, but how we accomplish that work, including the tools we use and the partners we collaborate with, may expand. I’m confident that the New Era of Smarter Food Safety will help us do our jobs better while protecting the public.
Smarter food safety isn’t just about developing new technology. It’s also about exploring simpler, more efficient, and more cost-effective approaches. And collaboration is a vital component of the Blueprint. That’s why we seek to collaborate and work with our stakeholders in new and creative ways.
This includes exploring the advancement of domestic mutual reliance, expanding the use of data and information-sharing agreements, and collaborating on new technologies. We’re in this together, and continued collaboration will be critical in helping to achieve a more modern approach to food safety.
And finally, the FDA continues to protect consumers from individuals and firms selling unapproved products claiming to prevent, treat, diagnose, or cure COVID-19, including by pursuing civil and criminal enforcement actions and issuing warning letters.
In March, we launched Operation Quack Hack, which leverages agency expertise and analytics to protect consumers from fraudulent products, including illegitimate test kits, unproven treatments, and counterfeit respirators.
Through this effort, the FDA has issued over 100 warning letters for more than 200 products, and roughly 75% of the recipients have voluntarily taken corrective action in response to those letters. The online marketplaces and registrars have reviewed and ultimately removed more than 500 product listings.
Working with the Department of Justice, we also have sought and obtained preliminary injunctions requiring defendants to halt the sale of products claiming to prevent or treat COVID-19, including one that, when used as directed, is equivalent to industrial bleach.
Ultimately, keeping bad actors out of the marketplace benefits all of us.
You can report fraud using the link seen in the slide. (https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet)
Our current challenges have presented opportunities to reassess how we work. We have come a long way, but we have much more to do. It is vital that we continue to take measures to ensure that the standards in the safety of food, drugs, and other products we regulate are being met. Looking to the future, ORA will continue to work to enhance our response to outbreaks, optimize our inspection process utilizing innovative technology, streamline our recalls, and expand the use of artificial intelligence and machine learning to screen imported foods.
We will continue to rely on collaboration to help us achieve our shared goal of protecting the American people. We look forward to working with you. Thank you again for your partnership and shared commitment to public health!
Now, I’d be happy to take any questions you might have.