IOM: FDA should work for better product-safety systems abroad

Apr 4, 2012 (CIDRAP News) – With the United States importing a vast river of foods and medicines from abroad, the US Food and Drug Administration (FDA) and other organizations need to increase their efforts to improve product safety monitoring in developing countries, the Institute of Medicine (IOM) said in a report released today.

Many low- and middle-income countries lack strong, technologically advanced regulatory systems, according to the IOM. The weak systems have allowed such products as suspect scallions, antibiotic-laced catfish, and contaminated heparin to reach US shores, says the report, which was sponsored by the FDA.

It recommends that the FDA and other agencies and organizations take 13 steps over the next 3 to 5 years to address the problem, such as helping to train regulators in exporting countries, focusing efforts on the highest-risk products and countries, and sharing inspection findings with other developed countries.

Imports tripled in 10 years
Imports of food and drug products regulated by the FDA have risen 13% per year since 2002, producing a cumulative tripling of volume since then, says a summary of the report. The nation now imports almost 40% of its fruit and nuts and 85% of its seafood. More than 80% of active pharmaceutical ingredients are imported as well.

The more than 150 developing countries share certain themes and challenges, but the report gives special attention to a few emerging economies that trade heavily with the United States: Mexico, Brazil, South Africa, India, Thailand, and China.

The IOM committee that wrote the report concluded that regulatory agencies and industries in the developing world face many barriers to protecting consumer safety, ranging from unreliable communication systems and water shortages to inadequate staffing, outdated equipment, and weak or nonexistent consumer-safety laws.

The FDA's traditional method of monitoring product safety—periodic inspections at factories and 300 ports of entry—is impractical when 20 million types of FDA-regulated goods arrive from more than 300,000 factories in 150 countries, the report notes.

To address this, the agency created a strategic plan called the Pathway to Global Product Safety and Quality, which extends the FDA’s safety focus for imports beyond US borders. But more effort will be required, the report says.

It calls on the agency to expand its existing risk-based process for targeting foreign manufacturers for inspection: "The committee suggests that enterprise risk management guide the FDA's training, regulatory, and surveillance efforts in the developing world. Enterprise risk management aggregates information about risks from across the FDA to give agency leaders a comprehensive analysis of threats. Agency officials then direct resources to the most pressing vulnerabilities."

Further, the agency should work with strong regulatory agencies in other countries to plan inspections and share data, the IOM says, commenting, "There is no need for American and European inspectors to duplicate each other's work, especially when a vast number of facilities go uninspected."

The report also recommends increased use of another existing tactic: offering incentives to importers to ensure that their supply chains meet US standards. The FDA has a pilot program that rewards drug companies for tracing their products from manufacture to entry into the US. If the program succeeds, it should be expanded to include food, the IOM says.

In other recommendations, the report says:

  • The FDA should work with partners such as other agencies, foundations, and universities to expand training in regulatory science and policy in developing countries.
  • The FDA and the US Department of Agriculture should work with private funders to develop low-cost tools and procedures for monitoring products from development through distribution.

FDA preparing rule for food importers
In a related development, a top FDA official said today that the agency hopes to publish soon a proposed rule that will require food importers to manage the safety of their supply chains. The regulation is one of four "foundational" rules that are being developed under the 2011 FDA Food Safety Modernization Act (FSMA), said Michael Taylor, the FDA's associate commissioner for foods, in a speech prepared for the Pet Food Forum in Schaumburg, Ill.

Taylor said the proposed Foreign Supplier Verification Program (FSVP) rule shifts the responsibility for detecting and correcting problems in imported food from FDA inspectors to importers.

"FSMA makes importers accountable for verifying, in a manner transparent to FDA, that the food they import has been produced in accordance with US standards, or under modern preventive controls that provide the same level of public health protection," he said. "The FSVP rule will lay out how importers can meet this new requirement."

The FDA also hopes soon to publish proposed rules dealing with preventive controls for human food, controls for animal food, and produce safety, Taylor said.

See also:

Apr 4 IOM report summary

Apr 4 IOM press release about the report

Apr 4 Michael Taylor speech

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