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Remarks of Mark Abdoo

FDA Associate Commissioner for Global Policy and Strategy

The International Bar Association World Life Sciences Conference

Washington, D.C.

June 1, 2023

Introduction

Good morning, everyone. I am delighted to be here this morning. First, I’d like to thank the 

organizers and the local host committee for inviting me to be with you today. I also appreciate 

having heard about the close relationship FDA has with DOJ from the first keynote speaker, 

Arun Rao. I’m Mark Abdoo, Associate Commissioner for Global Policy and Strategy at the U.S. 

Food and Drug Administration, and my office helps ensure global considerations are integrated 

into the FDA’s policies, regulations, programs, and strategies.

Today I am going to provide my perspective on “the FDA in the world,” which is a big topic. 

The FDA began engaging globally well before the rapid increase in imports caused by the efforts 

of manufacturers and producers regulated by the FDA to lower costs and improve productivity, 

fueling a cycle in which the quest for efficiency led to increased production abroad and higher 

volumes of imported products for the FDA to regulate.

And we did so for a few reasons: 

First, to become more effective and efficient. Globally aligning approaches to common problems 

allows us to be more effective in mitigating or managing them and relying on data and 

information collected by foreign regulators to support the FDA’s oversight activities generates 

efficiencies so we can focus our own resources in areas of greater risk.

Second, to benefit patients and consumers ... and industry too. International harmonization is a 

good example. International harmonization leads to improved efficiency in the regulatory review 

process, reduced time to get a product to the market, reduced patient burden through prevention 

of unnecessary duplication of clinical trials and postmarket clinical evaluations, and reduction of 

unnecessary animal testing without compromising safety and effectiveness.

Third, and perhaps most significantly, to keep Americans safe, which often has the collateral 

benefit of improving safety in other jurisdictions as well. Complex global and regional supply 

chains fundamentally altered the United States’ economic and security landscape and demanded 

a major change in the way FDA fulfills its mission to promote and protect the health of the 

American people. Just as public health leaders have long recognized that disease knows no 

borders, the FDA knows product safety and quality no longer begin or end at the border. 

Over the last few decades economic considerations — such as lower wages and investmentfriendly industrial policy — prompted a boom in outsourcing of manufacturing to India and 
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China and an increasing reliance on produce imported from Latin America. As international legal 

practitioners in the life sciences, you probably know that FDA-regulated products account for 

about 20 cents of every dollar spent by consumers. You also probably know many of these 

products originate from outside of the United States — such as produce from Mexico, seafood 

from Indonesia, drugs from India, and medical devices from China. And sometimes the 

regulatory frameworks of the countries from which they originate are outdated and provide 

insufficient oversight creating risks for U.S. patients and consumers that led to expansion of the 

FDA’s oversight and modernization of our mission delivery. 

Given this global landscape, the FDA must engage internationally to fulfill its mission. To give 

you a more in-depth perspective of “FDA in the world,” let’s consider the work of my office, the 

Office of Global Policy and Strategy, or OGPS. Among other things, OGPS manages the FDA’s 

foreign offices, two of which focus on products from a single country — in Beijing, China and 

New Delhi, India — one focused on products from the 44 countries of Latin America and the 

Caribbean, and one focused on cooperation with the mature regulators of Europe and the less 

developed regulators of Central Asia. This year marks the 15th anniversary of the opening of 

FDA’s first foreign office, in Beijing, and we are currently in the process of considering whether 

we need to adjust our overseas footprint to meet the challenges of the next 15 years. We opened 

these offices in response to a series of public health tragedies in which Americans were sickened 

or killed by poor quality or adulterated imported products, such as diverted and counterfeit 

glucose monitor test strips, adulterated heparin, and cantaloupes contaminated with salmonella.

Our foreign offices fulfill a critical role — they function as FDA’s eyes and ears in the country 

or region where they are located. Our staff closely follow regulatory and market developments, 

accumulating vital expertise over time. They spot trends in manufacturing and product safety and 

quality. They meet with industry and government, educating them about FDA’s regulatory 

requirements, building relationships that simply wouldn’t be possible by engaging from afar. 

And yes, our staff also conducts inspections of manufacturing facilities in their host countries.

I am going to speak next about a few of the important approaches the FDA uses to fulfill its 

mission: global partnerships, collection, analysis, and dissemination of high-quality information, 

and policy coherence. I’ll provide examples of each approach and will also mention a few ways 

FDA’s authorities have changed in response to global developments. Let me start with FDA 

partnerships.

Partnerships

The FDA relies on strong domestic and international partnerships to achieve its public health 

mission. When a medical product shortage or a food safety problem arises in one country, it 

often causes a ripple effect across the globe. Often a single regulatory authority — even one with 

the resources of the FDA — may lack the tools to address such issues. Therefore, public health 

can be better protected when we work with others — and I mean others broadly, not just the 

FDA’s regulatory counterparts. 

Nothing makes this clearer than public health emergencies, during which collaboration with our 

partners is essential. Last year, to build immediate relief into the infant formula supply chain, 

The FDA engaged with U.S. Government and international partners that had specialized supply 

chain authorities, expertise, and influence. At the peak of the crisis, the FDA expanded access to 

infant formula by temporarily exercising enforcement discretion for certain infant formula 
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requirements on a case-by-case basis. FDA supported Operation Fly Formula to arrange for 

emergency transport of the essential product from outside the U.S. Between May and September 

2022, the operation facilitated over 70 shipments from Europe, Asia, and North America that 

imported over 6 million pounds of infant formula into the United States. These partnerships —

across multiple government agencies, regulators, and industry — helped the United States to 

address this shortage.

Another good example comes from the work of our India office, which builds coalitions and 

partnerships with in-country regulatory authorities, industry, academia, multilateral 

organizations, and nongovernmental organizations. In response to medical products with quality 

issues linked to manufacturing in India, our India Office devoted much of February to meet with 

regulators and industry to emphasize the importance of instilling a culture of quality in drug 

manufacturing. The FDA repeatedly emphasized that Indian manufacturing shouldn’t have one 

quality standard for products bound for countries with stringent regulatory authorities and 

another lower standard for its domestic market or countries in Africa and other locations with 

lower-resourced regulators. The FDA also encouraged India to set aside more resources to 

support its regulatory system. In turn, the Government of India hosted a series of internal 

meetings to deliberate pathways for developing more robust and consistent oversight for 

pharmaceutical manufacturing. Such engagement from the FDA benefits patients in the United 

States and, importantly, also benefits other countries that rely on drugs manufactured in India.

Over the longer term, the FDA has an interest in strengthening new regulatory partnerships. 

Africa is becoming a region of greater interest for the FDA, where attention to public health 

regulations and prioritization for Africa’s regulatory capacity has increased because of the 

pandemic. The FDA, through OGPS, is considering how best to help in standing up the African 

Medicines Agency — or AMA — dedicated to improving access to quality, safe, and effective 

medical products in Africa. We are working to support operationalization of AMA because it is 

the right thing to do, and, importantly, down the road a strong, well-functioning AMA will 

support manufacturing in Africa that could eventually contribute to resiliency and redundancy in 

supply chains for products Americans rely on. 

Information Sharing

Every one of our foreign offices serves as a critical hub where information is collected, analyzed, 

and transmitted back to FDA headquarters to inform the agency’s decision-making. Not only 

does the agency use information-sharing to inform its Centers’ longer-term regulatory policies on 

drugs, food, devices, and biologics, but also shares information to cope with emergencies.

An important way the FDA gathers high-quality information is through confidentiality 

commitments and mutual recognition agreements. A confidentiality commitment is a legal 

framework for the agency to share certain kinds of non-public information with our counterparts 

in foreign countries. The FDA signed its first confidentiality commitments with the European 

Medicines Agency or “EMA” 20 years ago. In the years since, the EMA and the FDA have 

established more than 30 technical expert groups that meet regularly for regulatory and technical 

discussions. These groups cover a wide range of topics, from oncology to patient engagement, to 

vaccines. 

Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, the FDA

received the authority to enter into agreements to recognize drug inspections conducted by 
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foreign regulatory authorities. Mutual Recognition Agreements between countries allow drug 

inspectors to rely upon information from inspections conducted by other countries, if the FDA

determined those countries’ authorities can conduct inspections that meet U.S. requirements.

There is much to be gained by collaborating with other regulators to reduce duplicative efforts 

and maximize inspection resources. In January 2023, we established an agreement with 

Switzerland and its drug regulator, Swissmedic. This kind of information sharing with our 

foreign colleagues has proven to be especially vital during global public health crises, like the 

pandemic, when we were unable to conduct foreign inspections and needed to rely on the 

authorities in the EU and UK for information to inform our decisions. 

Related to information sharing, the legal landscape across the world is changing in important 

ways. My office is monitoring laws in Europe and China that could affect the FDA’s collection 

and sharing of information. Some countries have data laws that impede sharing of medical and 

health care data or facilitate foreign access to data on people in the United States. In 2018, the 

European Union enacted a law requiring that organizations put in place certain measures if they 

collect, use, or store personal data originating in the European Economic Area. This law intended 

to ensure that the data is protected, even if transferred out of the area, and resulted in Europe’s 

General Data Protection Regulation or “GDPR”. 

The FDA’s Europe Office has been closely following the potential impact of the GDPR on our

public health activities. So far, the FDA’s bioresearch monitoring program, which oversees the 

conduct and reporting of FDA-regulated research, has been most impacted by the law. There 

have been instances in which FDA investigators have been unable to complete in-person

inspections due to data sharing policies, such as GDPR. While data sharing policies are only one 

challenge in conducting inspections, lack of clarity around GDPR impeded the FDA’s ability to 

review data remotely during the pandemic. 

China’s laws go even further. A 2019 report prepared for the U.S.-China Economic and Security 

Review Commission noted that China’s laws prevent the export of information about Chinese 

people and require a permit for research use of genomic information. Chinese law also authorizes

the central government to access private sector data, but with limited protections. The law is 

vague about information oversight that could allow collection of health information to go

unchecked and may have not just privacy and public health implications, but also national 

security implications for the United States.

Policy Coherence 

I’m going to turn, now, to a discussion of policy coherence — what it is, and how FDA 

contributes to it as part of our public health mission. The Organisation for Economic Cooperation and Development or “OECD” describes policy coherence as strengthening the capacity 

of governments to design, implement, and monitor coherent policies for sustainable 

development. This entails activities such as fostering synergies across economic, social, and 

environmental policy areas, as well as reconciling domestic and international objectives. This is 

a concept that has long been recognized in global development circles and is also relevant for 

some of our global work. The FDA promotes this concept by helping other countries or 

institutions like the World Health Organization, or WHO, think through how best to prevent one 

policy interest, such as reducing cost, from undermining another policy interest, like assuring 

safety.
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A good example is our work with the WHO on substandard and falsified medicines. The WHO 

estimates that more than one in 10 medicines in low- and middle-income countries are 

substandard or falsified. The reasons for this are varied — porous borders, lax oversight, 

pressure to reduce cost, and distribution of medical products through informal markets. And the 

effects are significant: adverse events, including death; increased out-of-pocket and government 

expenditure on healthcare; and loss of economic productivity and social mobility. In 2012, the 

World Health Assembly — the supreme governing body of the WHO — established the WHO 

Member State Mechanism on Substandard and Falsified Medical Products to consider ways to 

reduce the public health risk and harm caused by substandard or falsified medical products. 

Within this governance structure, the United States has spearheaded a workstream to better 

understand the complex drivers of distribution of drugs through informal markets to help develop 

coherent risk management and policy options that deconflict what could be competing interests: 

regulation of drug distribution, assurance of high-quality medicines, lower costs for consumers, 

and high level of access, including for rural and underserved populations, so countries can more 

effectively protect public health. Again, this work is not purely altruistic. By helping think 

through how countries can manage their own distribution systems, the FDA benefits U.S.

patients and consumers who travel across borders and purchase drugs they believe to be 

legitimate in unregulated, informal markets.

Another example is the “whole-of-governments” approach to combating illicit pharmaceutical 

trade that we’ve been working on with a variety of stakeholders. In some instances, there may be 

incoherence between policies that reward innovation and policies that promote access. 

Increasingly sophisticated criminal networks exploit this incoherence by facilitating access to 

lower cost products of dubious origin and quality. The policy tools necessary to combat the 

problem reside in multiple government departments and agencies (ministries in parliamentary

systems), which means no single stakeholder can effectively address the threat. Our office cohosted a series of workshops in 2022, culminating in a large two-day in-person event that 

brought together more than 110 representatives from government, multilateral international 

organizations, and industry. This initiative was groundbreaking in that it brought together 

relevant communities that sometimes inadvertently operate in silos: public health institutions, 

regulatory agencies, law enforcement authorities, intellectual property organizations, postal 

unions, customs authorities, trade organizations, industry stakeholders, and consumer groups.

The event allowed participants from all over the world to openly discuss trends they have been 

seeing with respect to illicit pharma products, and what strategies have worked best. 

Supply Chain Challenges

Before I conclude I’d like to touch on one of the major global public health issues confronting us 

today — supply chain disruptions. Our overseas offices give us a front row seat to observe the 

many elements buffeting the world’s supply chains of the products we regulate — from drugs to 

medical devices and infant formula. The fact is, every industry we regulate is at risk from supply 

chain issues, deeply embedded in “just in time” manufacturing methodology and sole sourcing to 

maximize profit, leading to low inventories, and offshoring of key elements to reduce costs. In 

the face of international strife and economic distortions, these risks have resulted in real-world 

consequences, affecting, for example, the availability of certain drug products and infant 

formula. The FDA has authorities that are helpful, and which Congress has expanded over the 

last few years, but they don’t match public expectations. As we’ve learned in the past few years, 
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supply chains can be disrupted by quality defects, public health emergencies, weather events, 

transportation disruptions, changes in how healthcare is provided, or simply changes in 

consumption habits. The result of such disruptions is often shortages of critical products.

The havoc that the COVID-19 pandemic played with medical product and food supply chains 

started a shift in how the agency evaluates the effects of manufacturing conditions on shortages 

and product availability. This relationship between manufacturing quality and product 

availability was brought into sharper focus during the nationwide shortage of infant formula due 

to the adulteration of formulas produced at one specific manufacturing facility. For the next few 

minutes, I’m going to speak about how some of FDA’s authorities and agency programs have 

evolved to help manage supply chain risks. 

In March of 2020, Congress passed the bipartisan Coronavirus Aid, Relief, and Economic 

Security (CARES) Act. The CARES Act provided the FDA with new authorities intended to 

identify and mitigate shortages of medical products by, among other things, enhancing FDA’s 

visibility into drug and medical product supply chains. The Act requires certain manufacturers of 

drugs or active pharmaceutical ingredients to create and implement a manufacturing facilityspecific risk management plan which evaluates the risks to the supply of the drug for that 

establishment. FDA’s draft guidance for industry on Risk Management Plans to Mitigate the 

Potential for Drug Shortages was published in May of 2022.

In January of this year, as part of the Consolidated Appropriations Act, Congress passed the 

Food and Drug Omnibus Reform Act (FDORA) of 2022. FDORA includes a host of interesting 

new authorities and requirements for FDA, some of which strengthen our oversight and 

understanding of critical supply chains. On the foods side, the Act includes a provision requiring 

that critical food manufacturers put in place a risk management plan that will be subject to 

review during inspection. It also requires the agency to create a new Office of Critical Foods that 

will be responsible for oversight and coordination related to the supply of products such as infant 

formula. 

With respect to medical devices, the FDA developed a Resilient Supply Chain Program, which 

has enhanced the agency’s capacity to prevent and mitigate supply chain interruptions and 

promote resiliency and redundancy. The program’s goals include identifying supply chain risks 

and developing strategies to prevent and mitigate medical device shortages. Despite all of the 

efforts the FDA has put into supply chain oversight and resiliency, the FDA cannot work in a 

vacuum. To further strengthen supply chains, we partner with other agencies within the U.S. 

Government, and with foreign counterparts. 

The United States needs resilient, diverse, and secure supply chains to ensure our economic 

prosperity and national security. Coordination across the Federal government and with partner 

governments is one step toward implementing policy frameworks that support a resilient supply 

chain, build redundancy, and address risks. Resilient American supply chains can also revitalize 

and rebuild domestic manufacturing capacity.

Conclusion 

So, where do we go from here? The same economic forces I mentioned earlier — such as lower 

wages and investment-friendly industrial policy that spurred manufacturers to open facilities in 

India and China in the 1990s — are now pushing some manufacturing toward Southeast Asia 

and parts of Latin America. The demographic and economic profile of Southeast Asian nations
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— large, young populations of educated labor — indicate likely continued growth in 

manufacturing. Similarly, in Latin America, Mexico has emerged as a powerhouse for Class I 

and II medical device manufacturing with continued growth projected in the region.

These economic forces and other market trends will continue to shape our regulatory future. As a 

result of supply chain vulnerabilities exposed during the pandemic, leaders continue to push for 

critical supply chains to have multiple scalable sources for producing foods, drugs, vaccines, and 

medical devices. This global push is catalyzing investment in manufacturing and in regulatory 

oversight in places that have historically not had a large export industry. These investments will 

likely require FDA to mitigate risks of new products entering the U.S. market and present 

opportunity to shape regulatory frameworks in countries where they are being developed.

Today I’ve touched on many issues, including changing legal landscapes in Europe and China, 

and how they relate to us in the United States. I’ve shared how FDA's partnerships, information 

sharing, and policy coherence efforts support the United States in navigating international market 

forces. In keeping with my charge, these are among the prominent challenges and opportunities 

for “the FDA in the world.” I hope my remarks have provided you with some insight that 

supports your global interests and endeavors to assist the legal community, influence the 

development of international law reform, and shape the future of the legal profession.

Thank you.