IOM report: FDA needs to focus on import safety

April 5, 2012

Imported food and drugs in the United States have tripled in the past decade, making it tougher on regulators to police the safety of products that Americans consume, the Institute of Medicine (IOM) said. About 85% of the seafood, 39% of fruit and nuts, and 18% of vegetables Americans buy comes from abroad, according to a new report conducted by IOM.

The report finds that many low- and middle-income nations do not have technologically advanced regulatory systems, which limits their oversight of food and drug safety. The discovery of a counterfeit version of the cancer drug Avastin earlier this year underscores the challenges for U.S. regulators as imports increasingly dominate the American market.

“The integrated global economy demands cooperation across borders—to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective,” Harvey Fineberg, President of IOM, wrote in the almost 300-page report.

The report recommends 13 steps that the U.S. Food and Drug Administration (FDA) and other organizations can take over the next three to five years to bolster the safety systems in developing nations. The institute focused on countries that are predicted to be major pharmaceutical and agricultural trading partners with the U.S.: Mexico, Brazil, South Africa, India, Thailand, and China.

Partners in this effort include other federal agencies, international organizations, the regulated industries, and regulators in developing countries. Recommended steps include encouraging the development of low-cost technologies to prevent fraud and assessing whether the pilot Secure Supply Chain program can be expanded. The report also urges the regulatory agencies in developed nations and industry associations to devise ways to share inspection results and emphasizes the importance of donor investment in developing countries’ regulatory systems.

IOM report