FDA Strategy Aimed to Ensure Safety of Imported FDA-Regulated Drug Products

June 30, 2011 9:47 AM

Food and Drug Administration (FDA) has announced new long-term strategies to help ensure the safety of imported FDA-regulated drug products, as more and more drug products are either manufactured overseas, or contain active ingredients produced overseas. The agency’s report "Pathway to Global Product Safety and Quality," (PDF) describes the four key elements FDA will focus on as it expands global efforts to promote and protect the health of United States consumers. As presented in an FDA press release, FDA will focus on:

1. Creating global partnerships and coalitions of regulators focused on ensuring product safety and quality.
2. Supporting the development of international data information systems by these coalitions of regulators, with a focus on ensuring product safety and quality.
3. Building additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. Leveraging the efforts of public and private third parties and industry and allocating FDA resources based on risk.

Stressing the importance of the strategy, Commissioner of Food and Drugs Margaret A. Hamburg, MD, stated, “Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete.” As noted in the press release, the new strategy is aimed to address anticipated global economic, labor, and manufacturing trends. The strategy builds on recent initiatives including increasing FDA inspections of foreign drug manufacturing, establishing international offices, collaborating with European Union and Australian counterparts on drug inspections, and participating in the International Conference on Harmonization and the Pharmaceutical Inspection Cooperation/Scheme, an organization of the drug manufacturing inspectorates from 39 countries.