FDA Says Greater Global Food & Drug Regulation Standards Needed
On January 31, 2011, the Food and Drug Administration Commissioner Hamburg gave a speech at the Council on Foreign Relations New York Symposium, stating that there should be greater cooperation and enforcement of regulatory standards internationally due to the negative implications of globalization on food and drug safety.
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New Food Safety Bill Promotes Accountability, Drug Safety Bill in the Works
The Food Safety Modernization Act was signed into law in January 2011 and called on the FDA to require a new level of accountability for all entities involved in the supply chain, from the farm to the fork. The Commissioner stated that the FDA faces challenges, but that the FSMA is a significant step in the right direction. Congress has also introduced a similar bill for drugs that would bring sorely needed modernization to FDA authorities. Additionally, the FDA and the Council hope to start a conversation on new food and drug regulation that will be continued in broader foreign policy circles and perhaps the G20 level by next year.
(See ITT's Online Archives or 01/04/11 news, 11010426, for BP summary of the Food Safety and Modernization Act.
See ITT's Online Archives or 02/14/11 news, 11021419, for BP summary of imported drugs bill being introduced in the Senate.)
FDA's Regulatory Vision Includes Global Coordination in Regulatory Standards
The Commissioner stated that the FDA needs to create a new vision of how it regulates to create a coherent global system of oversight and safety. This will mean greater coordination and enforcement of regulatory standards across nations to ensure safety and quality, regardless of where a product is produced. A global alliance of regulators has already begun to collaborate on the creation of a public health safety net for consumers. The new food safety law will also enlist the participation of public and private third parties, industry and other organizations. A modern means to share data globally also must be created to advance analytics to proactively prevent and identify problems.
Overseas & Border Protection Inadequate to Ensure Foreign Import Safety
The Commissioner stated that globalization has resulted in a rise in imports of foods, pharmaceuticals, medical devices, and even biologics. However, by changing the way that food and medical products reach U.S. homes, globalization has also made the U.S. increasingly vulnerable. In the past, FDA mostly regulated domestically manufactured products. Its activities for foreign imported products focused on catching problems at the border and limited overseas inspections. Today, the scope of FDA's regulated products is bigger and its traditional manufacturing site inspections and border examinations are inadequate.
Food/Drug Manufacturing to Move Overseas, India & China May be New Innovators
The Commissioner stated that globalization poses many new security threats through global supply chain's distribution of unsafe products. The pressure to reduce costs and increase productivity will also lead companies to manufacture in cheaper sites and global supply chains. Countries like China and India that already produce many foods and medical products used in the U.S. will likely be important centers of innovation, inventing new products that people in the U.S. will want to buy.