The Global Economy of FDA-Regulated Products Under Stress October 6, 2020

Speech | Virtual

• Speech by: Mark Abdoo

• To: Food and Drug Law Institute

Remarks to the FDLI 2020 Annual Conference

I. Introduction

It is a pleasure to be on this panel with my distinguished colleagues and to represent FDA’s global portfolio. I’m Mark Abdoo, the Associate Commissioner for Global Policy and Strategy at FDA. 

I don’t have to remind this audience that we live and operate in a globalized world.  The rise of multinational corporations over the past half century has yielded a 24-hour research and development cycle where projects seamlessly pass between teams in Asia, Europe, and the Americas and the inputs of products are sourced from around the globe.  As a result, FDA-regulated products originate from more than 150 countries and from approximately 135,000 FDA-registered foreign facilities.  

This complexity has raised the importance of FDA’s global portfolio. The office I lead - the Office of Global Policy and Strategy - advances globally FDA’s mission of protecting and promoting the public health of Americans; we do this in part by leveraging diplomacy and partnerships on significant scientific issues, where appropriate, to expand our reach and foster alignment.  FDA has worked internationally in multilateral and bilateral dialogues for years to understand how other regulators assess the risk of goods and determine safety and efficacy. Over this period, we’ve developed trustworthy and collaborative relationships, and consistently advocated for regulatory frameworks that are predictable, efficient, and modern, and underpinned by decision making that relies on data and sound science. These partnerships have always been important. But a global problem requires a global solution, and since the COVID-19 pandemic began, these partnerships have gone from important to critical. 

I’m going to devote the rest of my time to discussing some of FDA’s collaborative efforts first, with Europe and then with other global regulatory partners.   

II.    European Cooperation

COVID-19

The outbreak of the novel coronavirus hasn’t just stressed global manufacturing of medical products, it’s also stressed regulatory Agencies’ abilities to perform our responsibilities of assuring the safety, efficacy, and at times availability, of critical tools needed by our healthcare industry in the fight against this virus. Our continuous interactions with other regulatory authorities have been essential to ensuring not only a sense of partnership among regulators around the globe, but also ensuring transparency as to how each of us is approaching the regulatory challenges of this pandemic.

One of our most robust relationships - with the EMA - has proven to be vital in responding to public health crises. The FDA and the EMA have partnered in response to the COVID-19 pandemic by sharing information, data, and our current thinking as we work to assure the safety and efficacy of products as diverse as antiviral drugs, serology testing kits, and K95 respirators. 

Over the years our work with Europe in a few dozen specialized scientific working groups also brought in experts from other mature regulatory counterparts, including Canada and Japan. These groups have laid the groundwork for unprecedented scientific collaborations as the scope of the COVID-19 pandemic has expanded.

As we were suddenly faced with a global pandemic, antiviral experts exchanged information about the disease and discussed shared approaches to sound design of clinical trials. Our epidemiologists collaborated on how to use real world data to understand the benefits and risks of already marketed products being used to treat the disease.  Our pediatrics experts considered standards for studying COVID-19 pediatric protocols within the first month of the crisis.  There are many other examples, but it is only through a long-haul investment in building collaborative working relationships that these can happen.  

Our work with Europe and trusted international partners was further magnified by bringing pandemic-related issues to a larger forum, the International Coalition of Medicines Regulatory Authorities or ICMRA, which has shown itself to be an invaluable forum for medical products regulators around the globe to come together and share information and common challenges.  We are proud that FDA’s Janet Woodcock chaired the first ICMRA high-level Heads of Regulatory Authorities meeting in response to COVID-19 and, shortly after, in April, ICMRA issued a joint statement pledging its collective support in countering the virus.  

In March of this year, FDA’s Europe Office worked with EMA to organize and co-chair the first ICMRA global regulators meeting to discuss regulatory strategies to facilitate the development of vaccines for the novel coronavirus, work that had begun through cooperation between FDA and EMA.  It was through the ICMRA forum, that we were able to establish common understanding regarding preclinical data requirements allowing regulatory agencies to support first-in-human clinical trials for COVID vaccines.  Later, ICMRA continued collaboration by developing prioritization and guidance on clinical trials for COVID-19 vaccines and therapeutics.

FDA has also been in close contact with global regulators through the International Medical Device Regulators Forum (IMDRF). Early in the pandemic, FDA had standing teleconferences with regulators to exchange information, under confidentiality commitments, on a range of device-related issues such as emergency procedures enabling availability of critical devices, supply chain disruptions due to export restrictions, and potentially fraudulent products.

MRA

Our close working relationship with Europe has led to the mutually beneficial Pharmaceutical Annex to the US/EU Mutual Recognition Agreement, which allows our respective drug inspectors to rely upon information from inspections conducted within each other’s borders. As codified in Title VII of the 2018 FDA Safety and Innovation Act, the MRA means we can devote our inspectional resources to higher risk facilities while reducing repeat inspections for industry. In FY 2019, for example, over 100 drug quality inspections were performed by EU investigators that FDA needed to only review and classify. In 2019, the collective inspections by both FDA and EU investigators under the MRA covered 32% of the total global site catalog.  As we continue to implement the MRA for human medicines, our Center for Veterinary Medicines is making progress towards including veterinary pharmaceuticals in the scope of the Agreement.

III. Other Global Partnerships

Our work with regulatory partners around the globe must adapt depending on the partner – their regulatory and industrial landscape, their resources and sophistication, and, quite frankly, our level of mutual trust. In some cases, we’re an equal partner, but to a lot of regulatory agencies without the benefit of FDA’s resources, we also serve as a reference authority – they’re able to approve products for use in their market because FDA has already found that product safe and effective. 

In response to COVID-19, we’ve engaged with numerous partners to help them understand the scientific rigor FDA applies when assessing a product. This has not only underscored confidence in FDA’s approach, but also contributed to improved public health by making critical medical products available for people who need them in the countries that rely on FDA approvals. Since the pandemic began, FDA personnel in China, India, and Latin America have been on the front lines leading bilateral exchanges of information while also navigating the local COVID-19 restrictions where they live and work. Our Latin America Office, which has the responsibility of covering 44 different countries with varying levels of regulatory sophistication, has worked tirelessly to share important information on FDA’s EUAs for items like ventilators and test kits, as well as best practices for getting by in the face of product shortages.

FDA’s China Office, despite being evacuated from China to a safe-haven in the United States at the onset of the pandemic, has worked hand-in-hand with CDRH to identify personal protective equipment from China that meets FDA’s requirements, and then facilitate its export to the United States despite strict and often confusing export restrictions. They’ve also contributed to import alerts placed on Chinese manufacturing facilities that have tried to export substandard PPE products. 

Our India Office has worked throughout the year to mitigate the export restrictions that India placed on 28 separate API’s and formulations related to COVID-19. The last of these restrictions was lifted in June of 2020. We’ve also deepened our ties with India’s Ministry of Health and Family Welfare, with FDA entering into an MOU that has the objective of promoting access to high-quality, safe, effective, and affordable medications for Indian and American consumers.

IV. Conclusion

We’ve learned a lot from watching how global regulators have responded to the pandemic and look forward to continuing our bilateral and multilateral work, and in applying our new knowledge in support of FDA’s mission. By FDA standards OGPS is a relatively small office, with a very broad portfolio, but we’re staffed with talented public health professionals who are dedicated to working with regulatory partners to promote the health and safety of the American public.  Moreover, we’ve learned how important it is for FDA to maintain staff in key strategic parts of the world at times of public health need. They are literally the eyes and ears of the agency, helping to ensure the safety, quality, and effectiveness of medical products and food produced for export to the United States. 

Thank you.