The change in strategy will address trends expected to be seen worldwide in upcoming years:

  • 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 U.S. 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 new strategy also builds on changes already set in motion by the FDA. The FDA increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened a series of international offices in key locations.  FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization of the drug manufacturing inspectorates from 39 countries.  The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.

The FDA is also broadening its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible.  There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.

The FSMA recognizes the importance of partnerships in the success of this new food safety system, particularly in the area of imports.  For example, importers now have an affirmative obligation to verify the safety of the food they bring into the United States.  In addition, the FDA will establish a program for qualified third parties to certify that foreign food facilities are in compliance with U.S. requirements and can require certification as a condition of entry into the United States.  And, FSMA explicitly encourages arrangements with foreign governments to leverage resources.

“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety.  We can no longer rely on historical tools, activities and approaches,” said Acting Principal Deputy Commissioner of Food and Drugs John M. Taylor, J.D.  “Implementing this strategy is vital to the public health.”