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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States.
Washington, DC (Nov. 6)-The Interagency Working Group on Import Safety issued its action plan for ensuring the safety of imported products, including drugs, food, and consumer products, into the United States. The plan includes 14 broad recommendations and 50 specific action points.
President Bush established the Interagency Working Group on Import Safety on July 18, 2007, and in September, the working group put forth its strategic framework. The group, chaired by US Department Health and Human Services Secretary Michael Levitt, consists of representatives from federal agencies and departments, including HHS and the US Food and Drug Administration, the Departments of Agriculture, Commerce, Justice, Homeland Security, State, Transportation, Treasury as well as the Consumer Product Safety Commission, Environmental Protection Agency, Office of Management and Budget, and the Office of the US Trade Representative.
The action plan proposes a strategy focused on a risk-based prevention with a verification model that allocates import safety resources based on risk. The plans seeks to replace “the current snapshot approach to import safety,” in which inspections are made at the border, with a “cost-effective, prevention-focused model that maximizes the impact of public and private safeguards by identifying and targeting critical points in the import life cycle where risk is greatest and focusing attention and resources on these areas,” according to a government press release.
Highlights of the action plan’s recommendations include:
• Creation of a stronger certification process. This recommendation would allow agencies such as FDA to have the authority to require that producers of certain high-risk products in a particular country, under an agreement with that country, certify that their products meet FDA standards in order to export to the United States. In addition, voluntary certification should be encouraged for foreign manufacturers of other products. Products certified as meeting US safety standards could receive expedited entry.
• Encouraging good importer practices. The action plan recommends the adoption of best practices to improve import safety by providing incentives to importers to maintain the highest safety practices for products that carry greater risks.
• Increasing transparency. The plan recommends that the names of certified producers and importers of record that import products only from certified producers be made public.
• Exchanging import data. The plan suggests that the importing community, US Customs and Border Protection, and other federal agencies exchange real-time product and compliance data on each import transaction to better inform decisions to clear or reject import shipments. The action plan also recommends that strategic information-sharing agreements be concluded with key foreign governments to facilitate the exchange of import and recall data.
• Increasing US presence overseas. The plan recommends that product safety be a guiding principle of US cooperative agreements with foreign governments and that training for foreign inspection agencies be increased to build the capacity of foreign governments to ensure the safety of products exported to the US.
• Enhancing standards. The plan recommends that Congress give import safety and inspection agencies the ability to strengthen their standards, where needed. The plan suggests that these new authorities take into consideration industry best practices to leverage the knowledge and experience of those who best understand how the products are made.
• Strengthening penalties. To hold both foreign and domestic entities accountable and discourage the sale of unsafe products, the plan suggests that the federal government take steps to strengthen penalties against entities that violate US laws.
The working group recommends that representatives of the member departments and agencies meet within 30 days of the issuance of the report to assess progress in implementing the action plan and to discuss possible mechanisms for collaboration with the private sector.
In a drug-specific measure, the report says that HHS and FDA are negotiating binding agreements with the Chinese government to enhance regulatory cooperation for drugs, medical devices, food, and animal feed.
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