FDA says knowledge of overseas operations is vital to secure supply chain.(Import Safety)

WASHINGTON -- Ensuring a safe supply chain is a complex, ongoing process, and some at FDA feel they're working without a complete set of tools. "As the world has gotten bigger and complexity has increased, we don't have adequate information about supply chains, including participants and vulnerabilities," said David Horowitz, FDA's Assistant Commissioner for Policy in the Office of Policy and Planning, at the Food & Drug Law Institute conference April 22. "Our resources have not kept up with our workload or public expectations."

The agency's international involvement has increased steadily in 2008 and 2009. In addition to launching a number of safety initiatives and establishing bilateral and multilateral partnerships, FDA is doing its best to retain transparency. And officials have taken a new, investigative approach to securing the supply chain, collecting as much information as possible about the participants and companies involved.

What the agency needs now, said Horowitz, is an expansion of current activities, resources, authorities and--most importantly--a paradigm shift.

"We cannot continue to use the old paradigm that our borders are our first line of defense," said Murray Lumpkin, M.D., FDA's Deputy Commissioner for International Programs in the Office of the Commissioner. "Our first line has to be outside the U.S. ... We can't try to keep bad products out, but support the flow of good products coming in based on [our] knowledge of overseas operations."

Having opened several new foreign offices, FDA is increasing its international presence and regulatory capacity for overseas operations. Eventually, the agency hopes to perform foreign inspections in China, Latin America, India and beyond. More than 100 bilateral agreements, and confidentiality commitments with 17 countries, have been secured, all to boost educational efforts, emergency response and preparedness. "We do this bilaterally and regionally or multilaterally," said Lumpkin. "We do it under the umbrella of MOU, confidentiality commitments, implementation of action plans, and harmonization activities."

Draft and working policies also address myriad regulatory challenges and emphasize prevention and accountability. Many of these guidances take a collaborative approach, relying on a network of trusted foreign and state authorities to gather information and support regulatory decision making.

The Good Importer Practices draft published jointly by five executive departments, including the Department of Health and Human Services, and three independent agencies, recommends good practices for increasing compliance with safety requirements. "What's unusual about [the guide] is FDA was the lead in drafting, but it applies much more broadly to all these other cabinet agencies," Horowitz said. The guidance highlights applicable prevention and detection points throughout a product's lifecycle in addition to four main objectives:

* Establishing a product safety management program

* Knowing the product and applicable U.S. requirements

* Verifying product and company compliance with U.S. requirements throughout the supply chain and product lifecycle; and

* Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements.

Familiarity with the product and foreign manufacturer stress an important message in the document: Product and process understanding are crucial to a drug's safety. The Secure Supply Chain Pilot targets high-risk areas, incentivizing manufacturers to develop safe routes for product importation and to allocate resources where threats exist. ORA's Private Laboratory Guidance validates the quality of test results and encourages importers to use accredited private labs. "We have to develop systems to ensure validity and reliability of information," said Horowitz.

Monitoring the production processes and output of manufacturers overseas is a considerable undertaking at any level, whether surveillance involves eliminating questionable drugs or supporting the flow of safe products. While the agency doesn't focus exclusively on any one exporting country, it recognizes that China has been the common source of contaminated drug and food items and is included in the top 10 of every export list, including devices, biologics and foods.

Illnesses caused by contaminated heparin and food ingredients have proven that adulterated products can and will seep into the country. Global manufacturing has its benefits, namely rapid production and cost cuts, but its risks have changed the perception of both consumers and regulators.

'"The 21st century reality is [that] our borders are now boundaries, not barriers to our realm of activity, not barriers to disease, not barriers to product flow, not barriers to challenges of globalization," said Lumpkin. "What we're seeing is the reality of the challenges of globalization, which has fundamentally changed the environment for regulating food and medical products."

By Carrie Nathans

Managing Editor

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