New FDA Strategy to Tackle Imports, Supply Chain

FDA released a new strategy on June 20, 2011, that is aimed at meeting the challenges posed by rapidly rising imports (they’ve quadrupled since 2000) of FDA-regulated products and the growing complexity of the pharmaceutical supply chain. A report titled “Pathway to Global Product Safety and Quality,” calls for four key changes to protect consumers:

• FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality

• The coalitions of regulators will develop international data-information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets

• FDA will build in additional information-gathering and analysis capabilities with an increased focus on risk analytics and information technology

• FDA increasingly will leverage the efforts of public and private third parties and industry, and allocate FDA resources based on risk.

“Global production of FDA-regulated goods has exploded over the past 10 years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their US production facilities, making the distinction between domestic and imported products obsolete,” said FDA Commissioner Margaret A. Hamburg in the announcement. “There has been a perfect storm—more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”

In terms of how the new strategy and changing manufacturing environment will affect the pharmaceutical industry in the future, FDA’s announcement notes the following:

• “Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.

• Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical US manufacturing company relies on more than 35 different contract manufacturers around the world.

• Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.

• Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.”

The strategy builds on recent agency efforts to increase the number of foreign inspections it conducts and to collaborate more with global regulatory authorities by, for instance, joining the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).