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

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