Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Suspect scallions from Mexico. Catfish from China and Vietnam
laced with prohibited antibiotics. Contaminated ingredients, also from
China, used in the blood thinner heparin. The Food and Drug Administration
(FDA) is intimately familiar with the daunting task of policing
the safety of food and medical products faced by regulators abroad.
The agency’s regulatory oversight has grown in fits and starts over
decades, often in response to such product safety problems. Yet the
FDA is responsible for protecting American consumers from unsafe
food, medicines, biologics, and medical products that now originate
from many different countries—including some with weak regulatory
systems—and that are transported through complex supply chains.
Imports of food and drug products regulated by the FDA have increased
by more than 13 percent per year since 2002, resulting in a threefold
increase of products produced outside of the United States. Almost 40
percent of the fruits and nuts and 85 percent of the seafood that Americans
purchase come from abroad. More than 80 percent of active pharmaceutical
ingredients—the building blocks of medicines—are imported,
and 40 percent of medicines are imported as finished products. Further,
U.S. imports of medical devices quadrupled over the last 10 years.
Since the late 1930s, when a sweetened elixir laced with poison killed
more than 100, U.S. law has required drug manufacturers to prove safety
before the FDA permits sale of their products. Decades later, the exact
same poison has been implicated in product safety crises around the
globe. But many regulatory peers abroad lack the legal framework, funding,
training, and oversight that have helped to transform the FDA into one
of the world’s top-notch regulatory agencies.
Against this backdrop, the Institute of Medicine
(IOM) convened a committee of experts at
the FDA’s request to identify the core elements
of food, medicine, medical product, and biologics
regulatory systems in developing countries; to pinpoint
the main gaps in these systems; and to design
a strategy to leverage the expertise of the FDA
and other stakeholders to strengthen regulatory
Weak Regulatory Systems in Developing Countries
There are more than 150 developing countries
in the world. The committee’s report, Ensuring
Safe Foods and Medical Products Through Stronger
Regulatory Systems Abroad, identifies shared
themes and challenges among them, while also
giving special attention to the emerging economies
that trade heavily with the United States:
Mexico, Brazil, South Africa, India, Thailand, and
In such countries, regulatory authorities
and industry both face numerous hurdles
to protecting consumer safety, according to
the IOM committee. Barriers include unreliable
transportation and communication systems,
along with inadequate access to clean
water, electricity, and broadband Internet.
Further, regulatory agencies in developing
countries often have few staff positions,
difficulty hiring and retaining qualified workers,
outdated equipment, and skeletal surveillance
systems to track and monitor products.
In some of the poorest countries, no law governs
product safety; other countries have a weak
legal foundation for regulation. Finally, product
safety is not a high priority in countries with overwhelmed
health systems, poor sanitation, and
high mortality rates. The committee finds that
developing countries are unlikely to have robust
regulatory systems due to these infrastructure
and resource limitations.
Modern Regulatory Systems for a Global Marketplace
In its report, the IOM committee identifies
specific actions that the FDA should take to
improve product safety for consumers. The
FDA needs management systems that enable
the agency to target resources to the greatest
risks. It is neither good management nor
good sense to divide resources equally among
all regulated products, the committee reasons.
While the passage of the 2011 Food Safety
Modernization Act strengthened the FDA’s ability
to prevent and respond to outbreaks, the FDA cannot
continue to do its job well without substantive
improvements in the capacity of counterpart agencies
in emerging economies, the committee writes.
The committee also recommends that to close
critical gaps, the FDA work closely with industry,
other regulatory agencies, and international organizations
to ensure that only safe food and medical
products reach American consumers. Because
everyone has a stake in product safety, everyone
needs to take action to build regulatory systems.
The FDA’s traditional method of ensuring
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 different
countries. With this in mind, the FDA created
the Pathway to Global Product Safety and
Quality—a strategic plan that broadens the FDA’s
safety focus for imports beyond the U.S. borders.
A focus abroad is consistent with the agency’s
new responsibilities outlined in the Food Safety
Modernization Act. More will be required.
Since 2008, the FDA has used a risk-based process
to rank foreign manufacturers needing 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. This analysis should be
applied across domestic and foreign operations.
The FDA should use partnerships to drive
improvements in supply chain management.
The committee recommends that the FDA work
with strong regulators in other countries to plan
inspections and pool data. There is no need for
American and European inspectors to duplicate
each other’s work, especially when a vast number
of facilities go uninspected. Also, the FDA
should enhance incentives offered to importers
that make sure their supply chains fully adhere
to U.S. standards. One promising initiative is the
two-year FDA Secure Supply Chain pilot program,
which rewards firms that trace their products
thoroughly from manufacture to entry into
the United States. If it is successful, the committee
recommends expanding this pilot to include a
greater number of importers and food.