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Welcome to Andy's Take.
Last week I gave you my take on three of five priorities I set when I arrived
at FDA more than three years ago. Today I will address the remaining two priorities:
advancing FDA's Critical Path Initiative and transforming FDA for the new era
of globalization.
My Take is that to understand the importance of these two priorities, we must
recognize that rapid and radical changes in science and technology and in the
global marketplace now require FDA to engage the total life cycle of the products
it regulates, whether it is food going from farm to fork or medical products
from research lab to use by patients.
Through the Critical Path Initiative, the FDA of the 21st century is leading
in an international effort to modernize the sciences determining how FDA-regulated
products are developed, evaluated, and manufactured. What does this mean for
you and your family? It means that FDA must use new sophisticated methods to
assure that safe and effective products move quickly from the research stage
into the health care system. FDA is now implementing the most modern technologies,
including information technologies, to manage the huge amounts of information
it receives, reviews and communicates in approving new products. These products
will foster personalized medicine and personalized nutrition, and the Critical
Path Initiative will help assure that you benefit from this progress as soon
as possible but with even greater confidence in the quality of food and medical
products.
Today's globalized economy means that each year about 2 trillion dollars worth
of products enter the United States from more than 150 countries and territories
around the world. FDA regulates a large number of these products, and we are
responsible for ensuring that they meet U.S. standards for safety and quality
and do not jeopardize the public health or national security. To ensure that
FDA can meet these challenges, FDA launched an initiative called “Beyond
Our Borders,” and for the first time we are establishing permanent FDA
offices abroad in strategically selected parts of the world. This initiative
is based on increasing collaboration with foreign counterparts, learning more
about foreign exporters and their products, and providing technical assistance
to foreign regulators and industries. FDA has already opened locations in China,
India, and Europe, and just this week we opened our new main location in Central
America. Further new locations will be opened this year in the Middle East
and in other parts of India, Europe, and Latin America.
Food and medical products are essential to the health and well being of you
and your family. FDA is responding to both the great promise and opportunities
as well as the increasing complexity and challenges of the progress that is
occurring in science and technology around the world. This is essential to
our mission to protect and promote your health.
I look forward to you joining me next week for my final Andy's Take.
Andy
Andrew C. von Eschenbach,
M.D.
Commissioner of Food and
Drugs
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