June 07, 2011 Articles

A Global Outlook: FDA's Shifting Strategies to Address the Safety of Imported Goods

By Una Young Kang

This year, nearly 20 million shipments of imported drugs, medical devices, food, and cosmetics are expected to flow into this country. See Margaret A. Hamburg, M.D., Comm'r of Food and Drugs, Speech at the Center for Strategic and International Studies: FDA and the American Public: The Safety of Foods and Medical Products in the Global Age (Feb. 4, 2010). This figure represents, among other things, 15–20 percent of all food now consumed in the United States, up to 40 percent of all drugs that are taken by Americans, and up to 80 percent of the active pharmaceutical ingredients in those drugs. See id. Products regulated by the Food and Drug Administration (FDA) are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities. See id. Adding to the complexity is the lack of uniformity of regulatory standards and capacities of these countries. In addition, many imported products cannot be traced to a single foreign source because they are composed of a number of components, each of which may be sourced from a variety of different suppliers in different countries. See FDA's Foreign Drug Inspection Program: Weaknesses Place Americans at Risk: Hearing Before the H. Subcomm. on Oversight and Investigations, H. Comm. on Energy and Commerce, 110th Cong. (Apr. 22, 2008) (statement of Andrew C. von Eschenbach, M.D., Comm'r of Food and Drugs: Safety of Medical Products with Foreign Components) (noting that "[t]he complexity of products and their components grows alongside an industry that is dispersed and decentralized").

The Challenge
Standing between these imported goods and the American public are approximately 500 inspectors, who will typically be able to examine less than 1 percent of these products. See id. See also U.S. Gov't Accountability Office, GAO-09-803, Consumer Safety: Better Information and Planning Would Strengthen CPSC's Oversight of Imported Products, Report to Congressional Committees (Aug. 2009). The odds for inspection at the foreign sources of these goods are equally modest. For example, the FDA inspects only an estimated 8 percent of foreign drug manufacturing facilities each year. See FDA's Foreign Drug Inspection Program, supra. Moreover, there are legal and logistical limits on the FDA's ability to conduct extraterritorial inspections. For example, a Government Accountability Office report released on May 6, 2010, identified several gaps in the FDA's enforcement of imported foods that can only be remedied by granting the agency additional authority. See Food Safety: FDA Could Strengthen Oversight of Imported Food by Improving Enforcement and Seeking Additional Authorities, U.S. Gov't Accountability Office Testimony Before the H. Subcomm. on Oversight and Investigations, H. Comm. on Energy and Commerce, 111th Cong. (May 6, 2010) (statement of Lisa Shames, Director, Natural Resources and Environment). Recent high-profile safety failures of imported foods and drugs into the United States underscore the dangers of relying on inspections to stop dangerous imported goods from reaching American consumers. For example, in 2008 and 2009, contaminated heparin (a blood -thinning drug) manufactured in China caused deaths and allergic reactions of consumers the United States. See, e.g., "Chinese Factory Linked to Drug—Heparin—under Inquiry in U.S.," N.Y. Times, Nov. 4, 2008.

A Paradigm Shift at the FDA
Oftentimes, the immediate public reaction to imported food and drug safety failures is to call for more inspections of the goods arriving at U.S. ports from foreign countries. Yet, focusing on inspections is a reactive approach with shortcomings that grow more apparent each year in the face of a rising tide of imports. Indeed, given the disparities between the FDA's available resources and the nearly overwhelming volume of imported goods, the FDA Commissioner of Food and Drugs has acknowledged that "it is simply not possible for FDA to inspect [its] way to safety." See Hamburg, supra. Moving beyond the limitations of an inspection-centric model of import safety is a paradigm shift that was first articulated in 2007, with the FDA's Import Safety Action Plan, and continues today. See Interagency Working Group on Import Safety, Action Plan for Import Safety: A Report to the President (July 2008). Within this new paradigm, the U.S. border is reconceptualized as one of many "integrated checkpoints." FDA's Foreign Drug Inspection Program, supra.

The FDA's forward-looking approach focuses on several key areas:

  • inspection and quality control of imported goods that occur closer to the source
  • aid in the development of the regulatory capacities of developing nations
  • greater coordination among regional, international, multinational, and intergovernmental institutions
  • development of a system of incentives and enforceable sanctions to influence the actions of exporter countries

See Thomas J. Bollyky, Global Health Interventions for U.S. Food and Drug Safety: A Report of the CSIS Global Health Policy Center 2 (Nov. 2009).

These changes make sense in the context of an increasingly globalized marketplace of goods, but how does such an approach translate into practice?

Concrete Results to Date
Over the past three years, the FDA has intensified its efforts to establish and maintain a permanent regional presence in countries that export large amounts of food and drugs to the United States, with three offices in China, two offices in India, offices in Costa Rica, Mexico, and Chile, and more anticipated to open. See Food Safety: FDA Could Strengthen Oversight of Imported Food, supra. In addition, the FDA has entered into two legally binding memoranda of agreement with the FDA's regulatory counterpart in China, pursuant to which the United States may inspect Chinese food and drug manufacturing facilities that export to the United States, require Chinese manufacturers of drug components to register with Chinese drug regulators, and permit foreign third-party certification. See Agreement Between the Department of Health and Human Services of the United States of America and the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on the Safety of Food and Feed, Dec. 11, 2007; Agreement Between the Department of Health and Human Services of the United States of America and the State Food and Drug Administration of the People's Republic of China on the Safety of Drugs and Medical Devices, Dec. 11, 2007; see also Bollyky, supra; U.S. Food & Drug Admin., FDA Beyond Our Borders (Dec. 9, 2008). The FDA has also engaged in more than 30 agreements with other foreign counterparts that emphasize information sharing to facilitate better decisions about the safety of imported products. See Hamburg, supra.

New Tools to Streamline the Existing Inspection Process
While the FDA is deemphasizing an inspection-based system for maintaining the safety of imported products, the agency is improving the inspection process itself. See FDA's Foreign Drug Inspection Program: Hearing Before the H. Subcomm. on Oversight and Investigations, H. Comm. on Energy and Commerce, 110th Cong. (Nov. 1, 2007) (statement of Andrew C. von Eschenbach, M.D., Comm'r of Food and Drugs). Since 1998, the FDA has used the automated Operational and Administrative System for Import Support (OASIS) to make processing and admissibility determinations for shipments of foreign-origin, FDA-regulated products offered for entry into domestic commerce, in conjunction with the U.S Customs and Border Protection's Automated Commercial System. See U.S. Food & Drug Admin., Office of Regulatory Affairs, Office of Res. Mgmt., Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting; Briefing Slides for Importers and Entry Filers (rev. Sept. 24, 2010) [PDF]. See also Operational and Administrative System for Input Support.

OASIS collects and generates Import Refusal Reports, which identify products for which an FDA determination to refuse admission to part or the entire product offered for import was made. Id. The information for OASIS is obtained from importers, who are required to submit data electronically, including the commercial description of the product, manufacturer, shipper, country of origin, and FDA product code, to the FDA through an Automated Broker Interface. Id. OASIS then routes admissibility decisions directly to the importer within minutes, electronically. Id. The FDA also issues "Import Alerts," which publicly identify imported products that may be automatically detained or detained without physical examination (DWPE) for a variety of reasons, including any one factor or a combination of factors such as a manufacturer, importer, grower, or geographic region that has been flagged as violating the Food Drug and Cosmetic Act. The FDA explains its use of Import Alerts as follows:

The purpose of an Import Alert is to identify and disseminate import information (such as problems and violative trends) to FDA personnel, thus providing more uniform and effective import coverage. Import Alerts identify problem commodities and/or shippers and provide guidance to FDA personnel regarding the importation of the products and/or firms covered in the alert. They may also concern products or manufacturers that have met the criteria for detention without physical examination. See Small Business Assistance: Import and Export of Human Drugs and Biologics.

A recent Import Alert identifies a list of all firms and their products that are subject to DWPE for pesticide residue on food products. See Import Alert 99-08, Sept. 1, 2010.

The FDA recently unveiled a new system designed to enhance targeted screening efforts by its inspectors. This new system is known as the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system, which uses artificial intelligence in conjunction with foreign and domestic analytical and inspectional data to identify products and shipments posing the greatest safety risks. See Margaret A. Hamburg, M.D., Comm'r of Food and Drugs, Speech at the Center for Strategic and International Studies: FDA and the American Public: The Safety of Foods and Medical Products in the Global Age (Feb. 4, 2010); see also U.S. Food & Drug Admin., Office of Regulatory Affairs, Office of Res. Mgmt., Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting; Briefing Slides for Importers and Entry Filers (rev. Sept. 24, 2010).

PREDICT does not alter the number of inspections but ranks shipments according to risk, which should allow FDA inspectors to target risky shipments more effectively, as well as expedite the entry of non-violative goods. See U.S. Food & Drug Admin., Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting, supra. To illustrate the interplay between OASIS and PREDICT, OASIS tracks FDA corrections of data submission errors, while PREDICT uses this data to adjust the targeting scores for future entry lines. See id. Pilot programs of the PREDICT system were launched in the ports of Los Angeles and New York, and a much-vaunted nationwide launch was expected during the summer of 2010. However, the agency announced in April of last year that the nationwide launch of PREDICT has been indefinitely delayed due to technical issues resulting from the agency's outdated information technology infrastructure, which is in the process of undergoing major upgrades. See The Role and Performance of FDA in Ensuring Food Safety: Hearing Before the H. Subcomm. on Oversight and Investigations, H. Comm. on Energy and Commerce, 111th Cong. (May 6, 2010) (statement of Michael R. Taylor, Deputy Comm'r of Foods, U.S. Food & Drug Admin.).

Recent DevelopmentsThe Food Safety and Modernization Act
Recently, on January 4, 2011, President Obama signed into law the FDA Food Safety and Modernization Act (S. 510) (FSMA), Pub. L. 111-353, 110th Cong., 2d Sess. (2010), which amends the Federal Food, Drug, and Cosmetic Act (FDCA) by addressing food safety issues, including import safety. Specifically, the FSMA provides for (1) the creation of a foreign supplier verification program in section 805 of the FDCA, which requires importers to "perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of the importer is not adulterated under [FDCA] Section 402 or misbranded under [FDCA] Section 403(w)"; (2) a voluntary qualified importer program, which requires the FDA to provide for the expedited review and importation of food offered for importation by importers who have voluntarily agreed to participate in such program under section 806 of the FDCA; (3) an import certification authority under section 801 of the FDCA, pursuant to which the FDA may require certifications of compliance of an article of food offered for import into the United States; (4) development of a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments, and their respective food industries, from which foods are exported to the United States, required by section 305 of the FSMA; (5) inspection of foreign food facilities under section 806 of the FDCA; (6) accreditation of third-party auditors to issue certifications for purposes of the FSMA's import certification and voluntary qualified importer programs; and (7) the establishment of foreign offices by the FDA under section 308 of the FSMA. Id.

Since the FSMA was signed into law, the FDA has announced a public meeting on the act, Food Safety Modernization Act: Title III—A New Paradigm for Importers, scheduled for March 29, 2011, to solicit comments on the act's import safety provisions. Notice of Public Meeting, 76 Fed. Reg. 13,643–13,645 (Mar. 14, 2011). The FDA will follow this public meeting with a public hearing, Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries, which is scheduled for March 30–31, 2011, and intended to provide stakeholders the opportunity to discuss the FDA's use of international comparability assessments as a mechanism to enhance the safety of imported foods and animal feed. Id. at 13,642. In addition, there will be a separate discussion regarding the FDA's efforts to gather information from foreign regulators regarding their import practices and policies. Id.

As these recent developments suggest, a holistic approach to import safety is necessary. Globalization has created new challenges for the FDA, but perhaps it will provide solutions as well, as the FDA continues to explore cross-boundary cooperation and enforcement mechanisms as a component of a larger import safety program.

Keywords: litigation, products liability, FDA, imported goods, globalization


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