By: Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis, and FDA’s Acting Deputy Commissioner for Global Regulatory Operations and Policy
Even in this modern era, when so much can be done remotely, there are many tangible benefits to having “boots on the ground” when doing business overseas. That’s the thinking behind the FDA’s foreign offices, which play a vital role in inspecting foreign manufacturing facilities, gathering market and industry information, and building closer relationships with local regulatory bodies, all in the interests of protecting the public health of Americans.
This month marks the 10th anniversary of the opening of FDA’s first foreign office, in Beijing. We believed it was important to have a local presence in China after the public health crises caused by the economic adulteration of two Chinese-produced products — pet food laced with the plastic substance melamine to cheaply boost the appearance of protein content, and adulterated heparin, the blood thinner, that had been contaminated with a related, but less expensive, chemical.
Although a public health tragedy was the catalyst for FDA to open an office in China, the new office within FDA’s Office of International Programs (OIP) was timely because of that nation’s growing importance as a leading source of ingredients and components across the spectrum of FDA-regulated products.
And it was in keeping with FDA’s OIP’s broader responsibilities, working with governments, industry and academia in foreign countries, as well as with multilateral organizations, to help assure that FDA regulated exports, like food, tobacco and medical products, to the United States meet U.S. standards. Today, with 300,000 foreign facilities in more than 150 countries exporting FDA-regulated products to the United States, FDA works beyond U.S. borders to ensure that products coming into the United States are safe and effective.
Since the first foreign office opened in Beijing in November of 2008, FDA’s international presence has grown to include additional foreign offices in New Delhi (India is also a substantial source of active pharmaceutical ingredients (API), raw materials, finished drugs and various food products including spices); Brussels (the headquarters of the EU); London — soon to be Amsterdam (the headquarters of the European Medicines Agency); and, reflecting their importance in providing fresh fruit and vegetables and other food products to the United States, three offices in Latin America — in Mexico City, Mexico; San Jose, Costa Rica; and, Santiago, Chile.
Conducting inspections of foreign facilities that manufacture FDA-regulated products for export to the United States has always been a critical component of our foreign offices, and it always will be. But early on, the agency recognized that an approach that focuses on risk-based inspections and enforcement alone could not fully protect Americans from unsafe foreign goods. We learned there were other protective advantages to having a local presence. It allowed FDA to provide local companies with hands-on training and real-time feedback on how to meet FDA’s regulatory requirements and made it easier for FDA to advise foreign regulatory authorities on how to build their regulatory capacities. It also enabled us to closely monitor and report on conditions, trends, and events that could affect the safety, quality, and effectiveness of FDA-regulated imports.
Today, our approach to information-gathering and sharing has become an important function of our foreign offices. They feed information into Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT), a risk-based tool developed by FDA to screen all regulated shipments imported or offered for import into the United States. Our foreign offices also use Global Watch for communicating with FDA Centers and our Office of Regulatory Affairs about emerging trends relevant to the agency’s public health mission. Global Watch is aimed at enhancing the agency’s ability to proactively identify and assess external intelligence impacting FDA-regulated sites, leading to a more timely regulatory response and risk-based decision making process. It has proven helpful in identifying concerning sites and products, developing inspectional and analytical strategies, and ultimately in helping to mitigate or prevent foodborne outbreaks and potential drug quality risks.
Relationship-building is another benefit that comes from having a local presence in a significant international market. By maintaining an office in both Brussels and London (eventually Amsterdam), we can better leverage our resources and collaborate with our regulatory partners on higher-risk sites around the globe that sell food and medical products to both Europe and the United States. In fact, we now communicate with our European regulatory counterparts on a daily basis.
Such relationships become all the more important since public health challenges and emerging public health threats do not recognize borders. FDA plays a critical role in protecting the nation from chemical, biological, radiological and nuclear threats and emerging infectious diseases — and having foreign offices and fostering relationships with foreign regulators is pivotal to this role. We often use international arrangements with regulatory counterparts to fulfill this important work. For example, during global public health emergencies like Ebola, Zika, and the Middle East Respiratory Syndrome Coronavirus, FDA established confidentiality commitments with key regulators to exchange and share related information concerning medical countermeasures in real time.
An increasingly important priority of the foreign offices is advancing some of FDA’s major strategic goals. Our offices in Beijing and New Delhi are currently working with local drug manufacturers on quality improvements, which could help facilitate more first cycle approvals of generic drugs — consistent with the goals of FDA’s Drug Competition and Access Plan. In Latin America, our staff is serving as an essential resource for produce growers as we implement the Produce Safety Rule under the FDA Food Safety and Modernization Act. And looking ahead to the future, our foreign offices will continue to strengthen our engagement with foreign regulatory partners on FDA’s science- and risk-based approach to advance innovation in plant and animal biotechnology and help bring safe and beneficial products to American patients and consumers.
Establishing a presence overseas is a complex and delicate process. In fact, the agency has faced its share of organizational challenges, especially when it comes to recruiting and retaining the right staff and keeping teams in place long enough to build valuable institutional knowledge within each foreign office. These challenges have hampered our ability to operate at full efficiency, as noted in the Government Accountability Office’s 2017 Drug Safety Report. To address these issues, we developed and implemented a strategic workforce plan that includes tracking vacancy rates and average deployment processing times for our foreign posts and providing both overseas comparability and special retention pay to staff. These measures are already beginning to pay off — with the goal of having fully-staffed foreign offices that can better meet their critical responsibilities.
FDA has also made significant progress in strengthening our performance monitoring capabilities. We now have a standardized and systematic way to monitor and track the progress of each foreign office so we can measure the contributions they make to FDA’s public health goals. Building on OIP’s strategic priorities, these metrics track output and outcome measures of both our internal and external interactions. As the program continues to evolve, FDA will continue to assess how best to capture the unique value of the foreign offices.
We have learned much from our experiences over the last 10 years, and that knowledge will be critical in refining our foreign engagements to make the best strategic use of our human and other resources in an ever-changing global supply and manufacturing structure. Our world is not becoming smaller — quite the opposite, in fact — and we anticipate that the current, already high volume of products sourced in full or in part from overseas, will continue to increase. It is clear that we must continue to build on our current efforts and enhance our investment in foreign offices to fulfill our vital public health mission on behalf of the American people.