By: Mary Lou Valdez

Last week I had the opportunity to discuss many of the challenges of globalization in my FDA Voice post entitled Collaboration for a Global Product Safety Net. Today I would like to tell you more about what FDA is doing to meet the challenges of globalization as described in our new report entitled Global Engagement. The report showcases FDA’s role as a strategic leader and partner in improving global product safety and quality.

And we are also launching a new Global Initiative web page where starting today you will see regular updates on our work to carry out our public health mission on the global stage.

FDA is undergoing a critical transformation. As I discussed last week, the food and medical products we use are increasingly coming from overseas. The globalization of commerce presents an incredible challenge to FDA. We are being asked to do more than ever before and consumers expect us to ensure the safety and quality of FDA-regulated products.

FDA has made great strides over the last few years to address the challenges of globalization. The Global Engagement report chronicles these activities, organized by seven key strategic areas, including:

1. Establishing foreign posts
2. Strengthening regulatory systems capacity
3. Harmonizing science based-standards
4. Leveraging knowledge and resources
5. Conducting risk-based monitoring and inspections
6. Preparing and responding to public health crises
7. Advancing regulatory science

You will see that our current global engagement work complements FDA’s overall transformation. About 10 months ago, the Commissioner of FDA, Dr. Margaret Hamburg, released a special report, Pathway to Global Product Safety and Quality. This report established a global operating model for moving FDA from a reactive approach in which we merely intercept dangerous products, to a proactive approach where the arrival of harmful goods is anticipated and prevented. This global safety action plan will allow us to more effectively oversee the quality, safety, and efficacy of all products that reach U.S. consumers and patients in the future. It relies on strong and effective collaboration, improved information sharing and gathering, data-driven risk analytics, and the smart allocation of resources, leveraging the combined efforts of government, industry, academia, and public- and private-sector third parties. Most importantly, it anticipates the need for, and puts concrete steps in place to expand the global product safety net. 

FDA recognizes that it must transform itself from a largely domestically-focused agency reacting to a globalized world, to one that proactively engages in a regulatory environment in which product safety and quality know no borders.  I hope you will continue to visit our globalization web page and watch the transformation firsthand.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs and Director, Office of International Programs