BIO 2010 Today: Dr. Hamburg on Expanding the Agency’s Global Role

May 5, 2010
FDA Commissioner Margaret Hamburg spoke today at the BIO 2010 show in Chicago. Following are some of her remarks:

...FDA is an extraordinary place . . . I’ve been in my role as deputy commissioner for almost a year now. Before I took on this role, I remember hearing Senator [Ted] Kennedy say that FDA was the most important public health agency in our country . . . I was a bit surprised . . . but now that I’m in this role, I’ve come to understand how right he was.

FDA Commissioner Margaret Hamburg spoke today at the BIO 2010 show in Chicago. Following are some of her remarks:

...FDA is an extraordinary place . . . I’ve been in my role as deputy commissioner for almost a year now. Before I took on this role, I remember hearing Senator [Ted] Kennedy say that FDA was the most important public health agency in our country . . . I was a bit surprised . . . but now that I’m in this role, I’ve come to understand how right he was.

FDA is a science-based and regulatory agency, but our mission is to promote the health of the public . . . our responsibility and reach are enormous, and include oversight of food, drug, cosmetics, animal food and drug, some radiation products . . . and now even tobacco products. We really do have an extraordinary portfolio . . .

It’s clear that there is no other agency of government, not-for-profit, academic institution, or private company that can do what we do . . . if we don’t do our job well, there is no other backup behind us.

Another thing that surprised me . . . is how much people watch the FDA. For example, people are always counting the number of words that I say . . . how many times I say the word “safety,” for example . . . I think that’s the wrong way to look at FDA.

Dr. Hamburg then provided an overview of her and the Agency’s current mission:

We must continue to build the public trust in the Agency . . . overall you look at the accomplishments of the agency and they are extraordinary. . . we have the safest food and drug supply in the world . . . strengthening trust and confidence in FDA and ensuring that it’s reflected in everything that we do is a high priority moving forward.

Secondly, we need to strengthen science at the FDA and advance the field of regulatory science more broadly . . . we have to make sure we can attract and retain the best possible scientists within FDA and ensure their career development . . . we also need to strengthen our collaborations with scientists outside the FDA . . . we need to harness science and technology to streamline the regulatory approval process.

Thirdly, we need to respond to a globalized world . . . we can’t live in a world where we simply inspect things as they come in from overseas . . . we need to work to harmonize standards, and work with countries with less [developed] regulatory systems . . . to have greater assurance that they are meeting the standards that we expect . . . in a complex world, that benefits all of us.

--Paul Thomas

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