FDA Reports on Import Monitoring & Inspection, Regulatory Collaboration, Foreign Offices, Etc.

Imports of FDA-Regulated Products Have Increased Dramatically in Past Decade

The Report said the surge in the volume and complexity of FDA-regulated imports results in increased potential risks to the U.S. public and presents the FDA with many challenges.

Food. According to the report, as of 2011, roughly one in six FDA-regulated food products consumed in the U.S. is sourced from abroad, and this percentage is much higher for some foods, such as seafood (80%) and fresh fruit (50%). From fiscal years 2002 to 2010, overall U.S. food imports, as measured by number of tariff lines, almost doubled from 4.4 million to 8.6 million lines. According to the FDA, less-stringent regulations in many source countries, complex supply chains, and longer transit times for imported food all introduce more opportunity for contamination, spoilage, adulteration, and counterfeiting.

The FDA said it can only realistically inspect a small percentage (less than 3%) of the enormous volume of food products arriving at U.S. ports of entry, making it crucial that the Agency focus on ensuring that food products meet U.S. standards before they reach the U.S.

Drugs & Medical Devices. Similarly, since 2002, imports of pharmaceutical products and biologics have more than doubled, and medical device imports have quadrupled. The FDA said foreign-sourced pharmaceuticals now account for some 40% of the drugs consumed in the U.S., and 80% of the active ingredients in U.S.-consumed drugs are sourced from abroad. With respect to medical devices, imports now represent more than 35 percent of the U.S. medical equipment market.

The FDA said globalization of the medical product industry presents regulatory challenges because: (1) clinical trials of new medical products are increasingly conducted abroad; (2) imported medical products may pose risks including adulteration and substandard, counterfeit, and/or falsified products; and (3) a lack of unique identifiers across countries means that, when a regulatory authority discovers a problem with a medical device in one country, counterpart authorities in other countries find it difficult or impossible to know whether medical devices used in their countries are comparable or identical to the defective product.

FDA Maintains Foreign Offices, Risk-Based Monitoring & Inspection, Etc.

The FDA says that, in response to these challenges, it is utilizing a variety of engagement strategies, in partnership with other agencies and organizations around the world, to strengthen global regulatory capacity, develop and harmonize science-based regulatory standards; share and analyze information and data globally; etc.

These strategies include:

Risk-based monitoring and inspection. The FDA said it is developing strategies and tools that take advantage of the latest developments in science, engineering and information technology. Specifically, the FDA is deploying the following new systems:

• PREDICT. The FDA says that, with instant access to numerous FDA and public databases, PREDICT uses data mining and pattern discovery techniques to evaluate and rank FDA-regulated imports based on their potential health risk. The system provides entry reviews with a list of imports receiving higher risk scores, as well as those that appear to be in violation of U.S. regulations. FDA import entry reviewers use PREDICT to determine which imports should be examined or sampled for laboratory analysis; which should be referred to compliance officers for detention; and which should be cleared to enter U.S. commerce.
• Portable analytic instruments.FDA researchers have developed portable tools, now being deployed in China and India on a pilot basis, to screen for several potential contaminants in FDA-regulated products, including: toxic metals; diethylene glycol in drug syrups; sibutramine; and melamine.

International offices and posts. In response to several U.S. public health crises caused by imported food and medical products in 2007 and 2008, the FDA established several international offices around the world. Presently, the FDA maintains offices in China, India, Latin America, Europe, the Asia-Pacific Region (based in the U.S.), Sub-Saharan Africa, and the Middle East and North Africa.

The FDA said these offices coordinate regulatory policy, provide information on U.S. regulations and gather information about foreign regulations, and strengthen regulatory capacity in foreign countries through training programs. Additionally, the offices in China and India maintain FDA inspectors, both to conduct regular inspections and to respond rapidly in times of crisis.

Knowledge-sharing, collaboration, and inspections. The FDA said it is working on arrangements to share knowledge and information, and collaborative partnerships for regulatory decision-making.

For example, according to the FDA, investigators with its Office of Regulatory Affairs regularly travel to inspect foreign facilities involved in producing food and medical products for import into the U.S. These inspections include both general surveillance, pre-approval, and responses to specific concerns. When an inspection identifies significant violations, the FDA may establish immediate controls to restrict the import of products from that facility until the violations are corrected. If a foreign facility refuses the FDA’s attempts to conduct an inspection, the FDA will restrict imports from that facility until an FDA inspection is conducted.

The FDA said it does not, and will not, have the capacity to directly inspect all high-priority foreign facilities regularly; for example, though the FDA inspected more foreign facilities in fiscal year 2011 than ever before, such inspections only accounted for a small fraction of the more than 300,000 foreign facilities manufacturing or processing FDA-regulated products for the U.S. market. Nonetheless, the FDA is conducting pilot programs to attempt collaboration with foreign food and drug regulatory authorities, including:

• In 2009, FDA joined with EMA and Australia’s Therapeutic Goods Administration to conduct a pilot program—the Active Pharmaceutical Ingredient Inspection Pilot. Before the pilot, these agencies had been conducting separate GMP inspections at the same overseas manufacturing sites, often within just months of one another. Under the pilot, the three agencies planned and conducted joint inspections at participating foreign facilities, and shared information from independent inspections they had conducted over the past two to three years. These exchanges have allowed FDA to redeploy inspection resources, and alerted the FDA to sites requiring heightened scrutiny. Since then, FDA has engaged in similar projects with additional counterparts.
• To enable closer regulatory cooperation, FDA and Health Canada (HC) initiated the pilot Multipurpose Audit Program in 2006. The pilot explored the potential benefits to medical device manufacturers and the agencies of using a single third party for inspections/audits to simultaneously meet FDA and HC regulatory requirements for systems quality. FDA and HC conducted 11 joint audit/inspections under the pilot, of which 10 were assessed for program benefit. Results showed that the joint approach reduced the time-in-facility spent at participating manufacturers by about one-third, on average, compared to the estimated time required for separate FDA and HC audit/inspections.

Global surveillance, preparedness, and emergency response. The FDA said it participates in global networks of regulators and non-governmental public health organizations, and monitors information from several international alert systems, including:

• International Food Safety Authorities Network (INFOSAN) -- a joint program of the World Health Organization and the Food and Agriculture Organization to monitor international food safety events;
• European Rapid Alert System for Food and Feed (RASFF) -- facilitates quick sharing of information when a food or feed-related public health risk is identified by a European Union state or organization; and
• WHO’s International Health Regulations (IHRs) -- these regulations legally bind 194 States Parties to help prevent and respond to acute public health risks that can potentially cross borders

The FDA said it also maintains an Emergency Operations Center, conducts traceback investigations, coordinates responses to foodborne illness outbreaks, etc.

Strengthening regulatory capacity. The FDA said it is working strategically with a range of countries to provide information, tools, training, and exchange programs that contribute to building or strengthening regulatory capacity in those countries.

Harmonizing science-based standards. According to the FDA, it has been working with counterparts for years to harmonize regulatory standards.

Advancing Regulatory Science. The FDA is actively engaging with global partners to harness scientific developments and pool products, resources, and brainpower to support science-based regulatory decision-making.

FDA to Engage Stakeholders on New Global Strategy over Next Several Years

The FDA also said it is working to transform itself over the next 10 years from a domestic agency operating in a globalized economy to a truly global agency, as described in its 2011 special report, “Pathway to Global Product Safety and Quality. Toward that end, the FDA says it will be collaborating closely with its foreign counterparts to assemble global coalitions of regulators dedicated to building and strengthening a worldwide product safety net, including a global data information system they can use to share information and resources across markets. The FDA says that it will be engaging stakeholders in a process that will unfold over the next several years.

Full FDA report on "Global Engagement" available here.