FDA Outlines New Plan to Increase its Authority Over Imports, Etc.
An official from the Food and Drug Administration discussed the agency’s Office of Regulatory Affairs’ plans for a new model of operations for managing imports at the April 2010 National Customs Brokers and Forwarders Association of America annual conference.
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(The FDA’s Office of Regulatory Affairs is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the U.S. ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans.)
The following are highlights of their comments:
New Approach for Managing Imports Needed
According to the FDA official, a new model for import operations is needed as the job of managing imports is increasingly global and complex due to factors such as more outsourcing of manufacturing; greater complexity in supply chains; imports coming from countries with less developed regulatory systems; and greater opportunities for economic fraud. The current model for managing imports is struggling to meet these challenges.
More Uniformity, More Authority Over Imports Sought
FDA’s new model will address these challenges; its goals for the new model include increased uniformity and efficiency, and increased authority over imports.
Draft Plan and “Strawman” ConOps Developed
FDA’s ORA has developed a draft Import Operations Strategic Plan and associated “strawman” concept of operations (ConOps). ORA proposes to analyze FDA’s National Import Operations Program, and has engaged an outside company to assist in the review and improvement of the strategic plan and ConOps.
FDA Will Also Look at Multiple Initiatives to Improve ORA Operations
The analysis will also take into account a number of other initiatives to improve ORA operations and to enhance ORA’s ability to protect the public health of the U.S. consumer by being more proactive in addressing potential health issues, utilizing a more priority-focused and risk-based approach across the entire life-cycle of products.
FDA Using a Phased Approach, Wants Final Plan in June
FDA is using a phased approach for its project and is on an aggressive timeline. FDA hopes to develop the final plan in June 2010.
There are a large number of specific stakeholders and initiatives whose role in import operations needs to be considered and/or addressed. FDA has identified three key sources of information and participation: (1) subject matter experts; (2) data systems and key documents for analysis; and (3) participation of key stakeholders (ORA, Centers, USDA, CBP, other federal agencies, states and localities, industry). FDA will be reaching out to these stakeholders for information in the near future.
FDA PowerPoint presentation from NCBFAA conference (dated 04/13/10) available via email by sending a request to documents@brokerpower.com