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Thank you for joining me for this week’s Andy’s Take.
As a physician I know that for a patient, getting better can be a painful and incremental process. As a leader I know the same can be true for an organization. This past week the Energy and Commerce Oversight subcommittee of Congress focused on what we at the FDA have known all along: the FDA of the 20th century has been the world's best but the FDA of the 21st century must be even better and it is urgent that the painful and incremental process of change begin now.
My Take on this urgent need to modernize the FDA is that it must be both about formulating and implementing the right initiatives as well as procuring the additional resources and authorities to implement them. Simply doing more of what we did in the past is a formula for failure in a world that has rapidly and radically changed around us. Changes are required across our entire portfolio from food and feed to drugs and devices, from expansion of the numbers and skills of our workforce to creation of a modern computer system and rebuilding our science facilities in the field and on a new centralized campus.
This week I had the opportunity to speak to Congress about the need to address the challenges of increasing foreign production of our medications. I invite you to read my prepared statement which focused on the globalization of the supply chain of drugs and pharmaceutical ingredients. But a substantial proportion of the products FDA regulates originate in other parts of the world. Globalization, increased product complexity, and other market developments are placing tremendous strains on our safety system.
In addressing this reality, FDA has been creating and implementing initiatives that focus on every component of the system, including enhancing our capacity for inspection. But we must also implement entirely new strategies.
We welcome your input into these plans as well as your support for sustained growth in the resources that are required. By applying resources the right way to do the right things, FDA is creating a still stronger, science-based and science-led shield to protect and advance the health of you and your family.
Please check back here next week for Andy’s Take.
Read my April 22, 2008 Congressional Testimony here:
http://www.fda.gov/ola/2008/foreigninspection042208.html
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
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