Pathway to Global Product Safety and Quality – FDA’s Report Regarding Improving the Quality of Imports

By Dara Katcher Levy –

Earlier this week, FDA announced the release of a report regarding the increasing globalization of FDA-regulated products that are consumed by Americans, and how FDA intends to improve the safety and quality of these products.  FDA states that the report was prompted by “this rapidly changing environment, and a desire to move from a posture of intercepting harmful products to anticipating and preventing the arrival of such goods.”

The bulk of the report deals with facts and figures about the increasing number of imports and how, if the numbers continue to increase at current rates, the agency, continuing as it has been, will be ill-equipped to ensure the safety and quality these products.  FDA states it plans on transforming itself over the next decade into “a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders” and will do so with an approach based on four core building blocks:

1. FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
2. With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
3. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
4. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

Much of the report is similar to Commissioner Hamburg’s statement to the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives given in April of this year.   

While it is laudable that FDA is taking action, reaching out to its foreign counterparts, and issuing this report, this “rapidly changing environment” has not rapidly changed overnight and has been “rapidly changing” for some time.  It’s unclear whether this report truly represents any “new” approach, rather, it appears this is a continuation of FDA's existing approach toward imports.  Although some of the facts and figures may have been updated, the statements in the report are essentially, not new.  Similar statements have been made by the FDA for years.  President Bush established an Interagency Working Group on Import Safety back in 2007, and FDA has provided updates since on its implementation of the “Import Safety Action Plan.”  FDA’s “Enforcement Story” Chapter 9, “Operations in a Global Environment,” provided an extensive look at steps being taken back in FY 08 to ensure import safety.  These steps included "Beyond Our Borders," an initiative to establish an FDA presence in foreign countries as well as partnerships with foreign regulatory agencies that included information sharing.  Further, since 2008, FDA has launched the PREDICT (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) system, software utilized by FDA that tracks historical data on importers, manufacturers, products, and even countries, to determine levels of risk for proposed imports, and to create consistency in FDA's approach towards these imports from port to port. 

Commissioner Hamburg’s prepared remarks for the Center for Strategic and International Studies in February 2010, address almost the identical issues contained in the most recent FDA report, including steps FDA intends to take to address these issues.  One development that could invigorate FDA’s efforts, at least with respect to imported foods, is the recent passage of the Food Safety Modernization Act (“FSMA”).  The FSMA substantially enhances FDA’s authority over imported foods, but also imposes foreign inspection mandates that the agency has indicated are unrealistic – particularly in light of budgetary constraints.

We hope the publication of this most recent report represents additional meaningful progress in implementing FDA’s stated goals.