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On April 23, 2012, the Food and Drug Administration (FDA) issued
a report on the FDA's plans
for increased global engagement. The report focuses on the
challenges which a U.S. domestic regulatory agency faces in
protecting U.S. consumers who are increasingly using products
from non-U.S. manufacturers and facilities.
The report begins by noting the enormous volume of imports of
FDA-regulated products. In 2009, for example, "$2 trillion
worth of FDA-regulated products manufactured in more than 300,000
foreign facilities entered the United States from more than 150
countries." Between 2002 and 2011, imports of
FDA-regulated products have grown substantially. This increase
in imports results in, as the report states, "increased
potential risks to the U.S. public."
In addition to the large volume of imports of FDA-regulated
products, including food and medical products, the report observes
that "[t]he increasing number of [medical product] clinical
trials conducted abroad adds to the complexities of FDA reviews of
product applications." These clinical trials are often
conducted in "nations with limited regulatory
capacity."
The FDA's global engagement strategies include the
following:
The FDA has opened offices in China, India, Latin America,
Europe, South Africa, and the Middle East. Through these
offices, the FDA seeks greater knowledge of the regulatory systems
of other countries, fosters relationships with other regulators and
develops information for inspection of foreign facilities.
The FDA proposes to work with the governments of other
countries to strengthen their regulatory systems in recognition of
the stake which the FDA and U.S. consumers have in the regulatory
systems of other countries.
The FDA recognizes the need for greater harmony in global
science-based regulatory standards.
Because inspection resources are limited, the FDA is focused on
developing tools to effectively identify the products which
pose the greatest health risks.
Regulated industry faces issues which mirror those which the FDA
is facing. Industry shares the FDA's interest in safe
products irrespective of the product's country of
origin. The challenge for industry is finding effective ways
to work with the FDA and regulators in other countries to build an
effective and reasonably efficient global regulatory
system. If achieved, products can move across borders and be
consumed in the U.S. and elsewhere with confidence that the
products are safe and are what they purport to be.
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