FDA:
International Regulators,
Industry and Import Safety
Welcome to Andy’s Take.
July 12, 2008
You are aware that an increasing
number of products –
especially those affecting your
health, like food and medical
products – are being
imported from beyond our borders.
This has raised great concern
recently about FDA’s ability
to ensure the safety of those
products. This week, I attended a
summit with hundreds of industry
leaders to collectively address
the challenges of product safety
in a global market place.
My take is that the challenge of
imported product safety will
increase because as American
consumers, we have come to expect
- and even demand – year
round variety in the food we eat.
And because the production of
many of the drugs and medical
devices we use is now a global
enterprise. So if we are going to
want safety in all these
products, it will require a
collective effort, through
collaboration with industry and
international regulatory
counterparts. This is to build
safety in to the production of
food and medical products as well
as to create systems that assure
their safety through distribution
and consumption.
That’s why the FDA is
accelerating initiatives like our
participation in a groundbreaking
program with partners in the
European Union and Australia.
Through a new pilot program we
will jointly plan, allocate, and
conduct certain inspections of
facilities in developing
countries that manufacture the
starting materials for many of
the drugs you take. If this
program is successful, it could
be expanded to include other
types of drug manufacturing
facilities. By leveraging the
resources of each agency and
sharing vital information, the
number of foreign facilities in
our inspection data base expands
while allowing FDA to target its
resources on products that we
believe present the highest risk
to US consumers.
We are also looking at new ways
to work more closely with
industry to protect our food
supply. This week, we announced a
pilot program for third-party
certification of aquacultured
shrimp, and we issued a draft
document that when finalized will
describe standards for third
party certification programs for
other food and animal feed
products.
International collaboration,
building new systems with trusted
partners, and working closely
with the private sector are all
elements of our FDA Beyond our
Borders initiative, our Food
Protection Plan, and the Import
Safety Action Plan. Through these
initiatives, we are setting the
course for the FDA of the 21st
century. As always, this is being
done to support our regulatory
mission to keep you and your
family safe – while you
enjoy what the amazing and
growing global marketplace has to
offer.
Please check back here next week
for Andy’s Take.
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
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