FDA report addresses safety concerns with imported goods
The Food and Drug Administration released a special report Monday that addresses rising number of foods and drugs being imported into the U.S. each year, and the challenges the agency faces in inspecting the safety of those products.
The report, titled Pathway to Global Product Safety and Quality, says nearly two-thirds of all fruits and vegetables and 80 percent of seafood consumed in America comes from outside the country. Additionally, half of the medical devices and 80 percent of the ingredients for pharmaceuticals that are sold here are manufactured abroad.
The number of products being imported has spiked in the last decade. In 2001, the FDA inspected 6 million products at 300 ports around the country; this year, the agency is expected to police 24 million products.
Meanwhile, the FDA is facing operational concerns. In January, the FDA Food Safety Modernization Act was signed into law, giving the agency additional power to inspect foreign facilities. The law requires the FDA to inspect 600 foreign facilities this year, and to increase that number ever year afterward. The report argues that at the current rate, it will take nearly nine years to inspect every high-priority pharmaceutical facility in the world just once. Also, in six years, the agency will struggle to reach the 19,200 food facilities it will be required to inspect, according to the report.
Additionally, just last week, House Republicans voted to decrease the FDAs annual inspection budget by $35 million. That reduction was part of a 12 percent decrease to the agencys total budget.
The report proposes four specific building blocks to help the FDA address the challenges that may come in the future:
- The FDA, in partnership with its foreign counterparts, will assemble a global coalition of regulators dedicated to strengthening product safety worldwide.
- The FDA intends to develop a global data information system and network in which regulators worldwide can share real-time information across markets.
- The FDA will continue to expand its capabilities in intelligence-gathering, with an increased focus on risk analytics and modernized IT capabilities.
- The FDA will allocate resources based on risk.
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