For FDA professionals focused on drug quality and safety, the rapid increase in imported drugs from nations where we devote limited inspection resources is of great concern. One way to address this concern would be to create an expanded inspectorate, one where investigators and inspectors from the FDA and trusted partners, such as those in the European Union (EU), would work together, rely on each other’s inspections, avoid duplicating inspections, and conduct more inspections in areas where the increase in drug manufacturing has greatly increased, like in China and India.

To meet this challenge, the FDA has responded with the Mutual Reliance Initiative (MRI). The concept is simple. EU country inspectors inspect in their respective countries, the FDA inspects the manufacturing facilities in the United States, and the EU and the FDA would rely upon each other. This would avoid duplication, lower costs, and enable the regulators to devote more resources to other parts of the world where there is greater risk. The savings would be considerable—over the last five years, about 40 percent of the FDA’s drug inspections were performed in the EU.

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