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The Food and Drug Administration is tasked with overseeing the safety and quality of most of the food, medical devices, drugs, biological products, vaccines and cosmetics in the United States. But every year, more and more of those products come into the country from other nations.
Fifty percent of fresh fruit, 20 percent of vegetables and 80 percent of seafood eaten in the United States comes from abroad, according to the FDA. Roughly 40 percent of finished drug products come from other countries and 80 percent of active pharmaceutical ingredient manufacturers are located outside the United States. In addition, about half of all medical devices are imported, the FDA says.
This growth of imported products has been rapid and is expected to continue to increase. That is why FDA Commissioner Margaret Hamburg says the agency must transform itself into a global health organization.
“Addressing the challenges of globalization was not something that I came to the FDA expecting to take on, but it has been a priority since the very beginning because the needs are so glaringly obvious and urgent,” Hamburg said in a March speech she gave at the Medicines and Healthcare Products Regulatory Agency in London. Hamburg added, “Frankly, this is an issue that keeps me up at night.”
Although she noted the benefits of a more global marketplace, she also outlined a number of challenges, including coordination with foreign regulatory agencies that are not as advanced as the FDA. Not all agencies share the same regulatory standards or enforce them to the same degree, and Hamburg said the FDA wants to improve quality and oversight in all countries that export products to the United States.
In addition, an increasingly complex global supply chain provides more opportunities for a product to be contaminated, diverted, adulterated or mishandled along the way — intentionally or not.
The risks from counterfeit or contaminated drugs are not just theoretical. In 2008, three Americans died after taking a contaminated version of the blood-thinning drug heparin that came from China. In 2012, the FDA found counterfeit Avastin, a cancer drug, in the United States and tracked it back to a foreign source.
For years, the agency has looked at ways to balance its resources and bring inspections of foreign facilities into more equal balance with its domestic facility inspections. In 2011, Government Accountability Office Health Care Director Maria Crosse said it would take the FDA nine years to review all foreign establishments subject to inspection if the agency maintained its pace.
That same year, the FDA issued its Pathway to Global Product Safety and Quality, with the goal of becoming a more global agency that treats risks the same way regardless of where they occur.
Part of that directive included creating a more visible foreign presence. The agency now has a permanent presence in 12 foreign posts and has more than 60 agreements with foreign regulatory agencies to share information, according to Hamburg.
“The number of facilities overseas, not just for drugs but for devices and for food production, is large and growing, and this is one of the reasons why we cannot be standing still,” Hamburg told a House Appropriations subcommittee in March.