Report to Congress on the FDA Foreign Offices
Report to Congress on the FDA Foreign Offices
Submitted pursuant to Section 308 (c) of the FDA Food Safety Modernization Act (P. L. 111-353)
U.S. Department of Health and Human Services
Food and Drug Administration
Table of Contents
- Executive Summary
- FDA Mission and Responsibilities
- The Challenges of Globalization
- Foreign Posts
- Progress and Selected Examples of Accomplishments of the Foreign Posts
- Obtaining Information on the Regulation, Production, Manufacture, and Transport of Products
- Providing Information on FDA Policies, Laws, Regulations, Standards, and Expectations
- Engaging in Technical Cooperation and Capacity Building
- Conducting Inspections and Investigations
- Environmental Scanning
- Cooperation with Other U.S. Government Agencies
- Strategic and Workforce Planning
- Plans for Additional Posts
- Annex A
- Annex B
This report describes the progress of the U.S. Food and Drug Administration (FDA or the Agency) in establishing foreign posts and the progress of those foreign posts in working with foreign government counterpart regulatory authorities and others in the countries in which the Agency has established such posts to accomplish the mission for which they were established. The report also identifies criteria for selecting the countries and FDA’s plans for any future offices. (NOTE: The term “office” has an organizational meaning within FDA; we believe the intent of this section of the Food Safety Modernization Act (FSMA) was to look at all of the foreign posts that FDA has established and not just the “offices” as that term is used in the FDA organizational context. Thus, we have used the term “foreign post” in this report, so as not to cause confusion in the two uses – organizational and generic – of the term “office.”)
The report outlines many of the current challenges faced by FDA because of the globalization of the products for which FDA is responsible domestically. These challenges are highlighted by the significant increase in the volume of FDA-regulated products imported from around the globe; over 300,000 facilities in 150 different countries produce products that enter the United States through over 300 ports of entry. Approximately 15 percent of the U.S. food supply is imported, and this percentage increases to about 75 percent for seafood and 50 percent for fruit. The processes and the supply chains through which these products are developed and produced are increasingly complex and represent opportunities for both safety and security problems to develop. Therefore, FDA must be more vigilant in taking measures to help prevent problems before they occur and to prevent products that do not meet FDA requirements from reaching any of our ports of entry.
In response to the changing global environment, on July 7, 2011, the Agency issued a report titled “Pathway to Global Product Safety and Quality.” One core building block of FDA’s new international operating model is to assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world. FDA’s establishment of foreign posts in strategic locations around the globe and deployment of staff to various postings enables FDA to work more closely with our foreign government counterparts and others within the “in-country” community on product quality and safety.
Generally, FDA’s foreign post staff is deployed to either U.S. embassies or consulates. However, as part of this strategy, FDA, in addition, has a senior technical expert embedded in the European Medicines Agency (EMA) in London, UK, and one in the European Food Safety Authority (EFSA) in Parma, Italy, to enhance opportunities to leverage respective institutional knowledge and resources. A senior technical expert from each of these European agencies is located at FDA as well. The criteria, listed in the report for identification of locations for the foreign posts, reflect both U.S. health priorities and the FDA mission. FDA has established 13 foreign posts as of June 30, 2011.
The foreign posts carry out a range of activities that make significant contributions to the FDA mission of protecting and promoting the health of U.S. consumers. This is accomplished by a series of activities in-country to enable FDA Centers and border officials to make better informed decisions about product entry into the United States. Activities include: a) enhancing relationships with our foreign government counterparts and working with them more closely on in-country efforts to help ensure product quality and safety; b) obtaining information about products destined for the United States; c) informing foreign governments and industry of FDA standards, guidance, and requirements; d) assisting, as appropriate, foreign governments in strengthening their regulatory capacities; e) scanning the local environment for incidents and activities that might have an effect on the availability and/or safety of products destined for the United States; and, f) conducting foreign inspections. Based on these objectives, the report highlights accomplishments of the foreign posts since they became operational in the various countries.
- enhanced interactions that allow the agency to obtain more information about how products are produced and transported to the United States;
- seminars and conferences in which FDA staff provides information on Agency policies, requirements, and expectations;
- workshops conducted to train foreign government staff in processes and methods to help ensure product safety;
- information-gathering to inform FDA’s decision-making on products at U.S. ports of entry;
- cooperation with other U.S. Government agencies abroad to share information and resources, and
- the conduct by in-country investigators in China and India of a total of 79 and 63 inspections, respectively.
Finally, this report summarizes FDA’s thinking concerning future foreign posts.
On January 4, 2011, U.S. President Barack Obama signed into law the FDA Food Safety Modernization Act (Public Law 111-353). Pursuant to Section 308(c) of FSMA, by September 30, 2011, the U.S. Secretary of Health and Human Services (HHS) is required to submit to the U.S. Congress a report on the basis for the selection of the foreign countries in which the Secretary of HHS established these offices, the progress such offices have made with respect to assisting the governments of such countries in providing for the safety of articles of food and other products regulated by the FDA exported to the United States, and the plans of the Secretary of HHS for establishing additional FDA foreign offices, as appropriate.
FDA Mission and Responsibilities
FDA is responsible for protecting the public health by ensuring the safety (including manufacturing quality), efficacy, and security of human and veterinary drugs, biological products, medical devices, and the safety of the food supply, cosmetics, dietary supplements, products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products. Prior to the passage of FSMA, in recognition of the fact that these products are exported to the United States from around the world, Section 1003(b)(3) of the Federal Food, Drug, and Cosmetic Act states that, as part of its statutory mission, FDA will “participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements.” Given the realities of 21st-century product globalization, FDA’s engagement internationally is an integral part of our public health activities and an integral part of how the Agency must act to meet its domestic public health mission.
The Challenges of Globalization
Globalization is a fact of 21st century economic life. It has resulted in U.S. markets containing a myriad of imported goods that U.S. consumers want and need. Globalization presents a host of internal and external challenges to the design, development, manufacture, and distribution of regulated food and medical products — challenges that complicate and even impede the prevention of, detection of, interventions with respect to, and response to product safety issues.
Today, there are more than 130,000 importers and more than 300 ports of entry in the United States. The diverse array of imported products that FDA regulates comes from more than 300,000 facilities in more than 150 countries. Challenges include:
- increasing volume of imported products from countries around the globe;
- greater complexity in the types of imported products reaching U.S. ports of entry;
- more foreign facilities supplying the United States with products and with the clinical data on which FDA is asked to base its marketing authorization decisions;
- increasing fragmentation and incomplete information about supply chains; and
- increasing opportunities for intentional contamination.
These challenges require a paradigm shift focusing on preventing threats to public safety before they happen. A key FDA response to these challenges is the establishment and operation of foreign posts. This initiative adds an important element to FDA’s preventive approach to food safety emphasized in FSMA. FDA must engage cooperatively with its foreign counterparts and other foreign stakeholders to better communicate and promote better understanding of FDA regulations and standards, and facilitate industry’s efforts to meet the requirements for FDA-regulated products that are exported to the United States. In addition, FDA must continue to exert its leadership as part of the global regulatory enterprise to assure that global regulatory standards are consistent with the best science and public health information available.
The primary purpose of posting FDA staff overseas is to engage more proactively and consistently with various stakeholders in strategic areas abroad to help prevent unsafe products from reaching U.S. borders and to help FDA centers and border officials make the best informed decisions possible about product entry into the United States. This engagement, which is detailed below, helps FDA better accomplish its mission to promote and protect the public health of the United States by helping to ensure the safety, efficacy (as appropriate), and quality of FDA-regulated products.
FDA overseas staff can often obtain information that is more complete, accurate, timely, and robust than information obtained from U.S. locations and sources. This information enables FDA officials in its Centers and Offices and at U.S. ports of entry to make better, more evidence-based decisions about FDA-regulated products that (1) are being developed for the U.S. market; (2) are being reviewed for marketing authorization in the United States; (3) are being presented for entry into the United States; and (4) are currently on the U.S. market.
FDA focuses on the following activities as these posts are established. As the Agency gains more in-country experience, FDA continues to refine its goals and objectives based on new knowledge, information, and experience gained. The primary objectives of FDA staff overseas are as follows:
Relationship Building: Engage with foreign counterpart regulatory authorities to establish and maintain collaborative and cooperative working relationships that ensure timely exchange of information regarding the manufacturing and distribution of food/feed and medical products that are exported to the United States.
- Obtaining Information on the Regulation, Production, Manufacture, and Transport of Products: Interact routinely with counterpart regulatory agencies and industry in country to: a) learn more about a country’s regulatory capacity and b) leverage their information and resources regarding the conduct of clinical trials and the manufacture of products in the country that will be exported to the United States.
Providing Information on FDA Policies, Laws, Regulations, Standards, and Expectations: Work with the regulated industries that wish to export their products to the United States to help ensure and increase their understanding of FDA’s requirements and expectations regarding FDA-regulated products. This work includes serving as a resource: (a) for industry, academia, professional organizations, trade groups, local governments, and in-country international organizations for information about FDA; and (b) to identify needed documents and technical experts within FDA, when appropriate, including triaging and prioritizing requests.
Engaging in Technical Cooperation and Capacity-Building: Partner with foreign regulatory counterparts to address regulatory issues of mutual concern and priority, and leverage each others’ information and activities, as appropriate. This partnering includes capacity-building to strengthen regulatory data and systems to help ensure the safety and quality of FDA-regulated products. Capacity-building, in turn, supports a data-driven approach to FDA decision-making.
Conducting Inspections and Investigations: As directed by the Office of Regulatory Affairs (ORA), FDA investigators posted in China and India conduct inspections of a routine, priority, or emergency nature and collect information about the manufacture of FDA-regulated products destined for the United States. This information-gathering increases FDA capacity for better targeting of inspections of high-risk facilities and high-risk products, and better analyses of risks around imported products.
Environmental Scanning: Assess conditions and events in-country that might affect the safety, quality, efficacy, security, and availability of FDA-regulated products exported to the United States. FDA’s Office of International Programs (OIP) country/regional Offices are responsible for “scanning” the environment within their geographic locales to obtain information that may be helpful to the FDA Centers, ORA and other FDA Offices, and senior executive leadership in their decision-making, while increasing the Agency’s knowledge of a country’s/region’s regulatory landscape. Please refer to Annex A.
Cooperation with Other U.S. Government Agencies: Coordinate and collaborate routinely on product quality and safety issues with other U.S. Government agencies at post that have complementary missions. These include, for example, the U.S. Departments of State, Agriculture, Homeland Security, Justice, and Commerce and their relevant agencies, the United States Trade Representative, and HHS Agencies, such as the Centers for Disease Control and Prevention (CDC).
Based on FDA’s experience, public health goals, and personal security concerns, the following criteria are used to select the countries in which FDA establishes foreign posts: (not all criteria apply to each selected site)
volume of imported products;
magnitude of the problems that have been associated with imported products over the years from certain countries/regions;
value to be derived, in terms of furthering FDA’s mission, from leveraging the activities and resources of trusted foreign counterpart regulatory authorities;
the ability of FDA to contribute to promoting U.S. public health priorities;
the stability of political and security environments in country; and
the political relationships and receptiveness of the country to the presence of FDA in-country staff.
The criteria, location of posts, and staffing are reviewed periodically to determine what changes may be appropriate due to shifts in the global environment, increasing complexities of supply chains, results achieved and budget realities.
FDA has 13 posts as follows (Please refer to Annex A for staffing):
China – Posts in Beijing, Shanghai, and Guangzhou;
India – Posts in New Delhi and Mumbai;
Latin America – Posts in San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico;
Europe – Posts in Brussels, Belgium; London, UK; and Parma, Italy;
Sub-Saharan Africa - Post in Pretoria, South Africa; and
Middle East and North Africa - Post in Amman, Jordan.
FDA employees deployed overseas are located at a U.S. Embassy or Consulate, with the exception of the two locations in Europe that, due to FDA’s advanced relationship with its regulatory counterparts there, have an FDA senior technical expert embedded in the EMA in London, UK, and in the EFSA in Parma, Italy. However, these employees are under the jurisdiction, respectively, of the U.S. Embassy in London, UK, and the U.S. Consulate in Milan, Italy. These experts serve as liaisons between FDA and the two European institutions to facilitate and further strengthen cooperation on a wide range of matters, such as clinical trials conducted in our respective jurisdictions and others, marketing applications, inspections and post-marketing surveillance with EMA, and risk assessments of products and chemicals with EFSA. Similarly, EMA and EFSA each have a liaison official embedded at FDA.
The most recent post openings were the deployment of a Senior Advisor for Sub-Saharan Africa in Pretoria, South Africa and a Senior Advisor for the Middle East and North Africa in Amman, Jordan. The U. S. Government, and FDA specifically, have an important interest in Africa through the investment in the President’s Emergency Plan for AIDS Relief, in which FDA provides its expertise to determinations of product safety and efficacy. The Middle East and North Africa represent an area of unique security and safety concerns, and having a person in-region will help FDA better address them through activities outlined previously.
The effectiveness of FDA’s work abroad is directly related, primarily, to the nature of FDA’s relationships with its foreign counterpart regulatory authorities. The Agency works hard to develop and strengthen relationships in a variety of ways, including a) regular meetings with foreign regulatory counterparts, industry, and academia; b) formal bilateral or multilateral forums; c) information exchanges; and d) technical cooperation and capacity-building.
The relationships between FDA and its foreign counterpart regulatory authorities in the countries where we have a permanent presence have been strengthened significantly, especially with China and Latin America. FDA’s relationship with its Indian counterparts is also improving. While FDA has longstanding and mature relationships with its regulatory counterparts in Europe, our permanent presence with the embedding of staff at the EMA and EFSA has further enhanced those relationships. FDA staff interacts with policy and technical counterparts on a wide range of issues on a weekly or daily basis. Examples of progress in relationship-building include:
- China – The State Food and Drug Administration (SFDA) is responsible for the export of drugs and medical devices, and the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) oversees the safety of exported food and animal feed.
The FDA China staff’s regular, monthly meetings, and numerous informal interactions, with SFDA and AQSIQ have increased FDA’s understanding of these agencies, e.g. their structures, operations, and capabilities, and the regulatory and political context in which China regulates products. The FDA staff also works with SFDA and AQSIQ to implement the Agreements signed with HHS in 2007. In support of the HHS/AQSIQ Agreement, FDA conducted extensive work to assess the ability of Chinese food laboratories to test for the presence of melamine and cyanuric acid in Chinese dairy exports to the United States. With the enactment of FSMA, FDA has reinvigorated talks with AQSIQ regarding its role in certifying food exported from China to the United States.
- India – Entities that govern food and drug regulation and policy include the Ministry of Health and Family Welfare’s Drugs Controller General of India, the Food Safety and Standards Authority of India, the Ministry of Food Processing Industries, the Ministry of Commerce and Industry’s Agricultural and Processed Food Products Export Development Authority, and the Marine Products Export Development Authority.
FDA’s India staff organized training in Good Clinical Practices for the Central Drug Standard Control Organization (CDSCO). This training has allowed CDSCO to progress from not previously inspecting clinical trial sites to the development of Indian inspection protocols and report formats for clinical trials and the issuance of a national guidance document on conducting inspections of clinical trial sites beginning in 2011. The findings from inspections conducted in India are used to inform India’s industry and Government representatives about how to improve the safety and quality of products exported to the United States.
- Latin America – FDA counterpart regulatory officials are located among the various Ministries of Health, Agriculture, Commerce, and Natural Resources. FDA has established contacts and has working relationships in Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, and Peru.
FDA has organized seminars and workshops throughout the region addressing food safety, food defense, and U.S. import procedures by leveraging resources with counterpart regulatory authorities, and enhancing relationships with multilateral organizations such as the Inter-American Institute for Cooperation on Agriculture (IICA) and the Pan American Health Organization (PAHO). Efforts of FDA’s Center for Devices and Radiological Health (CDRH), supplemented by technical advice from the Latin America staff, resulted in the Mexican and Costa Rican Governments’ acceptance of the FDA registration process for medical devices as equivalent to their own. This acceptance will reduce the regulatory burden for U.S. medical device firms exporting to these countries.
- Europe - EMA and EFSA are the primary EU agencies that regulate food and drug safety in Europe, along with the European Commission’s Directorate-General for Health and Consumers. Other counterpart agencies include the Swissmedic in Switzerland, and FDA counterpart national regulatory authorities in the European Union (EU) Member States.
FDA has well-developed relationships with the European Commission, EMA, EFSA, and with relevant national regulatory authorities in EU member and non-member countries. FDA’s Europe staff focuses on harmonization of standards, leveraging of resources, and exchanging data and information with our European counterparts. Important collaborations developed between FDA and the EMA include a process for industry sponsors to receive parallel scientific advice from the two agencies during the developmental phase of new drugs, both human and veterinary. FDA Europe staff has also made significant contributions to discussions between FDA and the European Commission on determinations of equivalence/comparability of specific food safety systems, including molluscan shellfish and Grade A dairy. The Director of FDA’s Europe Office serves on the Transatlantic Task Force on Antimicrobial Resistance and co-chairs the Task Force sub-group addressing the appropriate therapeutic use of antibacterial drugs in the United States and European veterinary communities.
Please see the first annual report of FDA and EMA’s activities at- http://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeign Offices/EuropeanUnion/EuropeanUnion/UCM261565.pdf.
- Middle East and North Africa (MENA) – Entities that govern food and drug regulation and policy in the MENA region vary by country. These entities include the Ministries of Health, the country's food and drug regulatory agencies (Jordan, Kuwait, Saudi Arabia), and specialized agencies for specific products (Morocco and Tunisia). Although the post in Jordan recently opened in June 2011, relationship-building activities have already proven valuable.
For example, the Agency received information on the brands of bottled water that were recalled from the market in Saudi Arabia and the Egyptian seeds company that was involved in the Fenugreek E. coli outbreak in Europe earlier this year. FDA’s MENA staff organized a food safety workshop in Egypt in 2010 for the regional food regulators. During this workshop, MENA staff made new contacts from the participating countries. FDA staff is also leading training in Saudi Arabia in Good Clinical Practices for the MENA drugs regulators. This training will enable the regulators to revisit and reevaluate their clinical trial regulations to developing their own if they have none. Also, FDA is participating in five food safety conferences in 2012 in the region to explain FSMA and its implementing regulations.
- Sub-Saharan Africa – The Medicines Control Council and the Food Control Directorate within the South Africa Department of Health govern drug and food regulation and policy. Many of the countries in Sub-Saharan Africa have bound together in multiple regional blocks, known as Regional Economic Communities (REC), in an effort to pool resources and expertise, share policy development ideas, and work towards mutual development. One REC, the Southern African Development Community (SADC) is dedicated to organizing its Member States to assist in strengthening the safety and security of the medial products supply chain in the region. Additionally, other African Union programs, such as the New Economic Partnership for Africa’s Development (NEPAD) provides for a strategic framework for countries in the region to adapt and modernize policy reforms and investments in the area of food and medical products.
FDA’s Sub-Saharan Africa Office and SADC worked with the Government of Botswana and Government of South Africa to conduct two “Train-the-Trainer” Good Clinical Practices/Clinical Research Inspection Workshops for SADC Member State regulatory authorities. This training provided an opportunity for FDA to strategically respond to the significant growth of international medical research and reach several governments in the region at one time. In September 2011, 13 of the 15 SADC Member States received FDA training in inspection protocols, report formats for clinical trials, and the need to harmonize inspection procedures. The Member State governments report that they have used the training to update their internal Standard Operating Procedures and many governments are seeking to update legislation to provide for more structured clinical oversight. The Sub-Saharan Africa Office continues to meet regularly with the SADC Health Secretariat to identify goals and objectives in the SADC Strategic Plan that are of interest to FDA.
Obtaining Information on the Regulation, Production, Manufacture, and Transport of Products
These activities enable FDA to better understand the regulatory landscape in other countries and learn about activities that will be helpful to the Agency in making decisions about resource allocations and strategies, e.g., conducting inspections and sampling products.
- FDA obtained information about actions and data from the EU in a timely manner concerning food contaminated with radiation from damaged nuclear reactors in Japan. This information added greatly to the Agency’s knowledge base and contributed to decisions on appropriate FDA actions.
- As part of the initiative to determine whether FDA and EU regulation of molluscan shellfish is equivalent, FDA Europe staff has facilitated inspections and meetings to obtain information on the EU regulatory system.
- Several times a year, FDA staff joins SFDA and AQSIQ staff on site throughout China to enhance FDA’s understanding of China’s complex regulatory structure. In addition, FDA China staff routinely engages with industry and academia regarding the role of science in regulatory systems and to identify training needs, such as seafood Hazard Analysis and Critical Control Points (HACCP), standards and practices for low-acid canned foods, and anti-counterfeiting and product integrity.
- FDA Staff in Latin America have visited countries in the Region and met with FDA counterpart officials to gain a better understanding of their regulatory systems and capacities to inform FDA decision-making and resource deployment in the Region.
Providing Information on FDA Policies, Laws, Regulations, Standards, and Expectations
These activities enable foreign regulatory authorities and industry to better understand FDA requirements to ensure compliance and reduce FDA’s burden of identifying non-compliant products at the border.
- The staff in the foreign posts responds to numerous inquiries related to exporting FDA-regulated products to the United States, including, for example, the purpose of certificates, Import Alerts and Bulletins, and detentions without physical examinations.
- The staff in the foreign posts makes many presentations to government, industry, and academia on a range of FDA-priority issues, provides related materials in other languages, and answers questions on FSMA requirements.
- Information on high-risk events, such as findings of food contamination by FDA laboratories, is provided quickly to the foreign competent authorities by the staff in the foreign posts to enable our counterparts to take appropriate actions in a timely manner.
- FDA’s Office of International Programs (of which FDA’s foreign posts are a part), in collaboration with FDA Centers/Offices, has expanded its translation of selected documents to expand outreach, understanding and utilization of a range of FDA regulations, guidance, and questions/answers.
Engaging in Technical Cooperation and Capacity Building
Selected highlights include:
The foreign posts are playing a key role in the implementation of FDA’s cooperative work with the Institute of Medicine (IOM). OIP has awarded IOM a contract to convene a study to assist FDA in identifying the core elements of needed regulatory systems development in developing countries, and based on these elements, help FDA and other relevant stakeholders to prioritize these needs and recommend a strategic approach to address regulatory capacity needs in the context of globalization. FDA staff in India and China coordinated meetings in country for the IOM Committee to collect information; Latin America and South Africa posts have likewise participated in IOM meetings held in country.
- FDA has conducted a number of training workshops in China, India, Latin America, and Europe on various topics covering FDA-regulated products as exemplified by:
- Low-acid canned foods and acidified foods
- Good Aquaculture practices
- Good Clinical Practices
- Good Laboratory Practices
- Good Manufacturing Practices for drugs
- Quality Systems Regulations for medical devices
- Food Security, Food Defense, and Food Protection
- Food Transportation, and
- Seafood Safety
- After the major earthquake in Chile in 2010, the Chilean Ministry of Health requested assistance in responding to a major outbreak of illnesses caused by norovirus. FDA staff in Latin America, in conjunction with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), provided expertise to advise the Chilean health officials, and organized a workshop on laboratory methods for testing foods and water for norovirus.
- Confidentiality arrangements with trusted counterpart agencies provide for the exchange of non-public information to facilitate cooperation on regulatory issues with regulatory authorities. Each regulatory counterpart commits, within the authority of its respective laws, to protect non-public information from public disclosure. These information-sharing arrangements are intended, among other things, to help regulators on both sides make informed decisions with regard to regulatory developments in their respective countries/regions. Information shared may include advance drafts of regulations and guidance documents, information on quality defects or product recalls, and inspection reports and product sample test results. Many such arrangements have been concluded or renewed in many of the countries covered by FDA’s foreign posts since they were opened. FDA maintains such confidential arrangements with many other countries around world and considers them a fundamental part of our relationships with advanced regulatory authorities. See the following link for a complete list of the arrangements: http://www.fda.gov/InternationalPrograms/Agreements/ConfidentialityCommitments/default.htm
Conducting Inspections and Investigations
FDA China and India posts, which include FDA investigators, interact proactively with ORA's Division of Foreign Field Investigations (DFFI) and Compliance Offices within FDA Centers to schedule and complete inspection assignments in a timely manner. Assignments and quality assurance of inspections is determined by ORA. FDA foreign posts are responsible for the administrative oversight of the inspectors in country. Other activities by in-country investigators include responding to needs that are identified as a result of reviewing import data, submissions of marketing applications, and participation in conferences and workshops. FDA investigators, based long-term in a single country, have now developed in-depth knowledge related to key industry sectors in China and India. FDA, in an unprecedented manner, is using information gleaned from inspections to inform its processes of risk analysis and assigning resources for training and capacity-building in more strategic ways.
The inspections are categorized as Emergency – related to an immediate public health problem; Priority – associated with a performance deadline, e.g. PDUFA goal; and Routine – general surveillance for conduct anytime during the year. The following tables detail the inspections carried out by FDA investigators deployed to the China and India posts:
FDA in-country investigators also serve as a resource for U.S.-based FDA investigators who also conduct inspections in countries where the Agency has posts. These investigators may need background information or other assistance from the foreign posts to complete their assignments. In-country FDA investigators have, in key circumstances, briefed U.S.-based FDA investigators in advance of their inspectional trips to inform their operational approaches. Although some posts, such as those in Latin America, do not participate directly in FDA inspections, they are very active in facilitating the communications between the Centers, ORA, the firms, and the foreign regulatory authorities. The posts provide information about agricultural and manufacturing industries, facilitate the participation of counterpart officials as observers to an inspection, and liaise with regulatory counterparts as appropriate in the completion of FDA inspections in foreign countries.
Inspections also provide opportunities for FDA in-country investigators to provide foreign counterpart regulatory agencies and industry with insights about FDA’s regulatory requirements in order to identify corrections needed to manufacturing processes or procedures that may produce safer or more compliant products for U.S. consumers. FDA strives to work collaboratively with in-country regulatory counterparts. For example, to better understand FDA requirements and processes and to build their own capacity, Chinese regulatory authorities have joined FDA investigators to observe inspections at facilities that produce medical devices and low-acid canned food.
Further, investigators deployed overseas provide FDA with the capability to respond quickly to emerging problems without the delays caused by the need for international travel, for example, obtaining a visa.
FDA has also implemented joint initiatives with foreign counterpart regulatory agencies with advanced regulatory systems to leverage our respective efforts to help increase the safety, quality and efficacy of products entering the United States and determine whether such products meet FDA standards. These cooperative endeavors allow FDA and the counterpart regulatory authority access to each other’s information to determine whether and how to allocate inspection resources in the most efficient manner. The foreign posts play a key facilitative role, as necessary, to help ensure the success of these initiatives. The following types of initiatives allow the Agency to leverage its inspectional resources with trusted foreign counterpart regulatory authorities:
- Good Clinical Practices Inspections
This program's objective is to share information concerning the sponsors of marketing applications as well as associated contract research organizations and clinical investigators. Some of the inspections were performed jointly and some were observational (each side observed the other’s inspectors). During this initiative, inspectors from Denmark, France, Germany, Spain, Sweden, and the UK have been involved in these inspections with FDA investigators. (Please see the report of this activity at: http://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeignOffices/
- Active Pharmaceutical Ingredient (API) Program
This program's objectives are to share information on manufacturing sites, exchange inspection reports and better understand the EMA and Therapeutic Goods Administration (TGA) of Australia inspection systems for APIs. Joint inspections have been held in China, Croatia, and India. The program started as a pilot with the EMA and the TGA in 2009, and has been converted to a permanent program. (Please see the report of this activity at: http://www.fda.gov/downloads/InternationalPrograms/FDABeyondOurBordersForeign Offices/EuropeanUnion/EuropeanUnion/UCM266257.pdf
- Finished Drug Pilot Program
The objectives of this program with EMA are to share information about manufacturing sites, exchange inspection reports, and better understand the EMA inspection system for finished dosage form products. The planning process was completed in December 2010, and joint inspections are being conducted during 2011.
OIP staff, including those at foreign posts, conduct ongoing environmental scanning to identify trends and events that may affect the safety, quality, and availability of FDA-regulated products exported to the United States. This information is shared with the FDA Centers and ORA on a weekly basis, unless such information is related to a more acute situation, in which case it is communicated immediately. Although the majority of the information provided does not result in specific follow-up compliance activities, they do add to the overall information analysis used to make resource utilization and other regulatory decisions. The following are, though, examples of specific potential product safety problems that resulted in sampling at U.S. ports of entry and, in the case of garlic powder, the issuance of an FDA Import Bulletin:
garlic powder suspected of heavy metal contamination;
food products from China suspected of pesticide contamination;
food products from India suspected of containing water contaminated with pesticides; and
flour products from China suspected of being bleached with limestone.
Please refer to Annex B for more information on environmental scanning.
Cooperation with Other U.S. Government Agencies
Coordination and collaboration with other U.S. Government agencies’ staff also located in-country at the U.S. embassies and consulates enable FDA to benefit from the experience and knowledge of these agencies in areas related to FDA’s interest. FDA and the other agencies are able to benefit, complement, and leverage each others’ resources in many ways. Being located in the same general area and being focused on similar products and issues in the same country/region enable a high degree of interaction on these issues. Some specific examples of our complementary work with in-country colleagues from other U.S. government agencies include:
FDA staff in India interact regularly with the U.S. Department of Commerce-led High-Technology Consultative Group and the Foreign Commercial Service.
FDA staff in India represented FDA/CFSAN to support U.S. Department of Agriculture’s (USDA) Foreign Agricultural Service (FAS) in negotiations with the Government of India on an acceptable export certificate for U.S. dairy products.
FDA staff in Latin America has ongoing collaboration with FAS and the U.S. Agency for International Development (USAID) to provide training and assess the analytical capacity of various government laboratories in countries participating in the Dominican Republic-Central America-United States Free Trade Agreement. The staff has used USAID resources to provide training to industry organizations and regulatory counterparts in the region. In addition, FDA staff has worked cooperatively with the Inter-American Development Bank (IADB) by providing speakers for regional workshops on good agricultural practices.
FDA staff in China and India has supported the United States Trade Representative (USTR) and the Department of Commerce by providing scientific information to the host country that facilitated trade of U.S. products.
FDA staff in Europe has accompanied the Administrator of the National Oceanographic and Atmospheric Administration to a meeting in Brussels, Belgium, with the EU Commissioner for Health and Consumer Protection to discuss the U.S.-EU molluscan shellfish equivalency project.
FDA staff in Europe has participated in discussions with USTR in Brussels to clarify facts on the status of the U.S.-EU molluscan shellfish equivalency project and agreed to meet on the issue with representatives of the governments of France and the UK.
Following the opening of the foreign posts, the staff at various posts drafted individual initial strategic plans in 2009 to guide their work. These plans proved useful to better focus goals and objectives and more strategically manage, measure, and address issues from a wide range of interested stakeholders. Based on our initial year of experience in country, OIP has developed a five-year strategic plan that incorporates goals, objectives, and actions for its international program, including its overseas posts.
In recognition of the challenges in hiring and maintaining a viable workforce to engage effectively in the global arena, FDA is also developing a workforce plan, which will involve identifying and documenting competencies required for overseas positions and developing strategies for the Agency to maintain its ability to attract and identify those with the necessary competencies in effective and efficient ways on an on-going basis to replace staff who rotate back to the United States. OIP already offers various learning opportunities such as seminars, forums, training courses, and lectures to the FDA community, with a primary goal being to reach employees FDA-wide who have an interest in working at or in support of an FDA foreign post. FDA has consulted with the CDC as it develops the plan. In addition to increasing skill sets and competencies associated with international work, FDA will develop a pilot program for employees to gain experience in working in a foreign country, drawing upon CDC’s International Experience and Technical Assistance (IETA) Program as a model.
These initiatives are consistent with the recommendations contained in the U.S. Government Accountability Office (GAO) report to the Committee on Oversight and Government Reform, U.S. House of Representatives titled “Food and Drug Administration Overseas Offices have taken steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed” at http://www.gao.gov/Products/GAO-10-960.
FDA has no plans to open additional foreign posts at this time. However, in early 2011, FDA requested permission to establish a post in Brazil, recognizing the increasing number of exports from Brazil to the United States. This would enable FDA to better leverage resources with Brazil and the region by building on previous technical collaborations and that country’s leadership in the region. Areas of interest include medical devices, tobacco products, and counterfeit medicines. Discussions have been held with the U.S. Department of State and the Government of Brazil regarding the posting of an FDA senior technical expert at the U.S. Embassy in Brasilia as part of FDA’s Latin America Office. While we have no set date for when such a placement would occur, we believe that further discussions with our Brazilian counterparts will enable us to move forward.
FDA Foreign Posts, Openings and Staffing (As of November 30, 2011)
(Staff On-site/Post Operational)
U.S. Direct Hires
Locally Engaged Staff
China – Beijing
China – Shanghai
China - Guangzhou
India – New Delhi
November 2008 (detailed)
June 2009 (permanent)
India – Mumbai
Latin America – San Jose, Costa Rica
Latin America – Santiago, Chile
Latin America – Mexico City, Mexico
Europe – Brussels, Belgium
Europe – London, UK
June 2009 (at EMA)
Europe – Parma, Italy
November 2010 (at EFSA)
Pretoria, South Africa
No longer staffed with 1 USDH and 1 LES. Possible re-deployment in 2012.
USDH deployed in December 2011. Will also hire 1 LES.
OFFICE OF INTERNATIONAL PROGRAMS
(STANDARD OPERATING PROCEDURE)
IN-COUNTRY environmental scanning
FOR BETTER DOMESTIC DECISION-MAKING
Careful monitoring of a country’s internal and external environments can help identify early signs of opportunities and threats that may affect FDA-regulated products and influence the Agency’s current and future plans. Staff in FDA’s Office of International Programs (OIP) – located both at headquarters and in the foreign posts – is responsible for scanning various environments within its regions of concern to obtain information that may be helpful to the Centers, ORA, and the senior executive leadership of the Agency in their decision-making.
OIP’s goal is to ensure that information provided to the Agency by its staff, including at the foreign posts, is credible and timely. OIP staff strives to be politically, linguistically, diplomatically, and culturally competent and well-versed in a diverse range of issues so that it can contribute to FDA domestic and international planning and execution of activities and strategic efforts to accomplish the FDA’s public health mission.
Generally, routine information will be obtained from public sources.
Based on input from FDA’s Centers and ORA as to what types of information would be most helpful to them in their decision-making, OIP routinely and proactively provides the following types of in-country information from its environmental scanning efforts:
- New information or perspectives on recent or ongoing public health issues;
- Weather phenomena that may result in disruption in production of FDA-regulated products and may affect the safety, quality, or availability of FDA-regulated products;
- Shortages of FDA-regulated products;
- Major changes in reports of animal health;
- Major changes in reports of human health;
- Recalls of FDA-regulated products;
- New initiatives undertaken by counterpart regulatory authorities related to FDA-regulated products;
- Major environmental issues (acute or chronic) that may affect the safety/quality of FDA-regulated products;
- Significant actions taken by counterpart agencies against FDA-regulated products imported into the country/region or produced domestically;
- Significant actions taken by counterpart agencies against FDA-regulated products being imported from countries other than the United States;
- New perspectives on counterpart Agency strengths and weaknesses gained through closer relationships with them;New perspectives on counterpart Agency activities or policy positions;
- Significant personnel changes/issues within counterpart regulatory agencies;
- Significant socioeconomic events (such as strikes, transport disruptions, dock shutdowns) that may affect the safety/quality/availability of FDA-regulated products;
- Economic or other problems that could motivate a firm to cut costs and engage in practices that compromise product safety; and
- Changes in the political landscape, including elections, political party changes, and/or patterns of civil unrest, that could impact FDA's work domestically and in country.
OIP staff is aware of the above list and over time, has determined how best to obtain and share this type of information/data consistently on a routine or emergency basis. As experience increases, revisions to the above list may occur to ensure continued relevancy to FDA’s public health mission and objectives.