FDA Continues Global Transformation

By Ellyn McMullin

In June of 2011 I published an article “FDA Wants to Transform into a Global Agency” after the Food and Drug Administration unveiled a new global strategy to help ensure safety and quality of imported products.

Recently, Howard Sklamburg, FDA’s Deputy Commissioner for Global Regulatory Operations & Policy posted a blog entitled “Ensuring Pharmaceutical Quality Through International Engagement” to provide an update on the Agency’s pursuit of global participation.

A key component of the FDA’s new approach (as detailed in a special Global-Transformationreport “Pathway to Global Product Safety and Quality”) was to partner with its counterparts worldwide to insure and improve global product safety and quality.

The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 included provisions to improve the safety and integrity of imported drugs sold in the United States. As reported by Sklamburg, FDA now has more than 60 agreements with their counterparts to share some information in inspection reports. With increased information-sharing and recognition of foreign inspections, there is an increase ability to evaluate pharmaceutical facilities. This arrangement also allows better decisions about the safety of foreign products.

The signed agreements with the European Commission (EC) and the European Medicines Agency (EMA) will expand the FDA’s trust to regulators outside of the US who are also committed to public safety and quality protection. The ultimate goal of the alliance of these organizations is to be more efficient and effective in targeting resources for inspecting pharmaceutical operations.

As Mr. Sklamburg states: “At every stage in the production of pharmaceutical products, and all along the global supply chain, things can go wrong. Products can be improperly formulated, manufactured, or packaged. They can be contaminated or counterfeited. And the challenges are multiplied when the supply chain stretches around the world.”

This initiative provides direction and assurances to Brand Owners as they implement their own Global Supply Chain strategies as were detailed in an Axendia Research Report entitled “Global Supply Chain Visibility, Control & Collaboration: Business Imperative, Regulatory Necessity.”

FDA continues to transform itself from a domestically-focused regulatory agency into a 21st century global health organization. This adaptation has come in the face of economic and technological changes that have revolutionized how it carries out its mission.

We will continue to monitor FDA’s transformation and report as new developments emerge.