According to the FDA half of all medical devices used in this country are imported, while 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.
In the last seven years, imports of pharmaceutical products have increased nearly 13% and devices have grown at over 10%. Between 2007 and 2015, it is estimated that imports of FDA-regulated products will triple, corresponding to a 15% growth rate.
On June 20, 2011, the United States Food and Drug Administration unveiled a new global strategy to help ensure safety and quality of imported products in an increasingly complex global supply chain.
“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,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “There has been a perfect storm – more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”
“FDA has been a domestic agency that works in the international world,” commented John M. Taylor, J.D., Acting Principal Deputy Commissioner of Food and Drugs. “What we need to do is transform ourselves into a global agency that is able to work all around the world and address product issues as they arise all over the world and we need the authority to allows us to do that,” added Taylor.
To detail this transformation, the Agency issued a special report, “Pathway to Global Product Safety and Quality”
According to the report, FDA’s international operating model will rely on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.
The new approach will rest on four core building blocks:
- FDA to partner with its counterparts worldwide to ensure and improve global product safety and quality
- FDA and its partners to develop an international data information systems and networks to promote the sharing of data and regulatory resources.
- FDA to develop additional information gathering with an increased focus on risk analytics
- FDA to leverage the efforts of third parties and industry and apportion FDA resources based on risk.
Many of these issues were detailed in Axendia’s Research Report entitled “Global Supply Chain Visibility, Control & Collaboration: Business Imperative, Regulatory Necessity.” The research report encourages Brand Owners to implement Global Supply Chain strategies to capitalize on the benefits of globalization and outsourcing while proactively reducing and controlling risks.
Request a copy of the report at: http://www.axendia.com/2010_LS_GSC.html