Contributed by Rebecca Jones McKnight and So-Eun Lee

Last month, on April 4, 2012, the Institute of Medicine (IOM) issued a report titled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.”  The report recommends 13 steps that the U.S. Food & Drug Administration (FDA) and other organizations can take over the next few years to bolster product safety systems around the globe.  See our prior discussion of related topics here and here.

International commerce is a reality of modern food production and medical product manufacture.  The IOM reports that about 85 percent of the seafood, 39 percent of the fruits and nuts, and 18 percent of the vegetables that Americans buy come from abroad, as do 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs. 

FDA now oversees 20 million import lines, including close to 7 million import lines for medical devices alone.  This represents a three-fold increase in regulated imports from a decade ago. 

Congress has reacted to these trends by authorizing FDA to inspect more imported products, but FDA does not operate in a vacuum; the agency’s success depends in part on its counterpart agencies in emerging economies. 

The IOM report asserts that international cooperation is needed to make meaningful improvements to product safety in the U.S. and around the world.  

The IOM report recommends 13 steps towards the goal of improving global regulatory systems.  These include:

Internationally:

• In the next 3 to 5 years, international and intergovernmental organizations should invest more in strengthening the capacity of regulatory systems in developing countries;
• In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue before policies are written and after they are implemented;
• Countries with stringent regulatory agencies should, within the next 18 months, convene a technical working group on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports;
• Industry associations should, over the next 3 years, define an acceptable protocol for sharing of internal inspection results among their members;
• Starting in the next 5 years, USAID, FDA, CDC, and USDA should provide technical support for strengthening surveillance systems in developing countries; and

Domestically:

• FDA should use enterprise risk management to inform its inspections, training, regulatory cooperation, and surveillance efforts;
• FDA should develop an information and informatics strategy that will allow it to do risk-based analysis, monitor performance metrics, and move toward paperless systems;
• FDA should facilitate training for regulators in developing countries;
• U.S. policy-makers should integrate food and medical product safety objectives into their international economic development, trade, harmonization, and public health work;
• FDA, which currently requires one-up, one-back track-and-trace requirements for food, should, in the next year, hold a multi-sector, international, public workshop on applying it to medicines, biologics, and (when appropriate) to devices;
• Starting in the next 2 years, FDA and USDA should implement Cooperative Research and Development Agreements and other programs to encourage businesses and academia to research and develop innovations for low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain;
• FDA should ensure an adequate mix of incentives to importers of food and medical products that are confirmed to meet U.S. regulatory standards; and
• Over the next 10 years, U.S. government agencies should work to strengthen the ability of those harmed by unsafe food and medical products to hold foreign producers and importers liable in civil lawsuits.

The report concludes that individual countries can no longer depend on their national regulatory authorities to guarantee product safety in the domestic market and urges international cooperation across borders to ensure that our food and medical products are safe and effective.

Globalization is here to stay.

Please contact us for specific advice on how your company can navigate this changing landscape.