Hearing Of The Subcommittee On Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Of The House Committee On Appropriations - Food And Drug Administration

Statement

The hearing is called to order.
I want to welcome Dr. Margaret Hamburg, Commissioner at the Food and Drug
Administration, in her first appearance before the subcommittee. She is joined by Patrick
McGarey, Director of the FDA's Office of Budget, and Norris Cochran, Deputy Assistant
Secretary for Budget at HHS.
As I have said many times over the years, and as I am sure you agree, funding the
FDA sufficiently is one of the most important responsibilities under this subcommittee's
purview. The American people expect the FDA to ensure the safety of the food they eat,
the drugs they take, and the medical devices they rely on. And they expect us to provide
the resources the agency needs to fulfill this fundamental mission on behalf of our
nation's families.
With that in mind, I am proud that, since taking the chair of this subcommittee,
we have continued to address our responsibilities in this arena. Starting in 2007, this
committee and Congress have worked in a bipartisan fashion to increase the FDA's total
budget by more than $878 million. And last year, our final conference report funded the
FDA at $2.36 billion, $306 million above 2009.
We do this because food and medical product safety is crucially important to our
national welfare. It is, in short, a national security issue. I am very proud that the agency
has been able to hire thousands of new employees -- scientists, inspectors, and analysts
doing critical work -- as a direct result of those increased resources. I am glad to see
newly proposed initiatives like the FDA Transparency Task Force that will help to
improve the functioning of the agency. And I think that, under Commissioner Hamburg's
direction, the FDA will invest resources smartly, improve its efficiency, and streamline
its organization, and that the agency's original emphasis on protecting the public health
will be restored.
Looking ahead to 2011, I am encouraged by the administration's $2.5 billion
request for discretionary resources provided by this Committee, an increase of six percent
over last year.
I am also glad to see that many of the agency's most important consumer safety
initiatives are seeing positive funding increases in this budget. The Center for Food
Safety and Applied Nutrition (CFSAN) is slated to receive an additional 9.2%. The
Center for Drug Evaluation and Research (CDER) and the Center for Biologics
Evaluation and Research (CBER) both see their funding upped by 4.2%; other centers are
slated for smaller increases. We will look at the requests for all the centers to make sure
the budgets proposed are both well-founded and sufficient to do their critical work.
Taken as whole, this budget represents a strong commitment to building on the
historic levels of investment this committee has made over the last four years. Coupled
with $1.5 billion in estimated user fees, this would give the FDA over $4 billion to meet
its responsibilities to the American people.
They will need every penny. In just the past month, we have seen new revelations
suggesting that the diabetes drug Avandia is unsafe and should not have been approved.
We have new research from the Yale Medical School that even brief exposure to
Bisphenol A, a common ingredient found in plastics and aluminum cans, causes
increased risks of breast cancer and uterine cancer for those exposed to it before birth.
We learned that the radiation treatments that cancer and other patients rely on for
help are in some disturbing cases causing harm.
We have witnessed a Salmonella Montevideo outbreak in crushed pepper that has
already sickened 245 people. And just yesterday, we found out that a processed foods
company in Las Vegas, Basic Food Flavors, knew their plant was contaminated with
salmonella and decided to proceed with business as usual.
These recent situations demonstrate yet again the sheer variety of responsibilities
the FDA must continually live up to, and the need for resources to ensure the safety of
these products.
I also have some concerns about the contingency of budget increases for food inspections
on the authorization of user fees. As you know, these fees are authorized in the House
food safety bill, but not at the same level in the Senate version. So it is an open question
how the agency intends to meet these fundamental inspection obligations if user fees at
the level in the budget are not authorized in the final legislation.
So, as we move forward with the budget process this year, and continue the
process of revamping and innovating FDA to meet its mission in the 21st century, I hope,
Dr. Hamburg, that you will continue to keep in mind four guiding principles I laid down
last year.
First we must continue to increase funding to support the FDA's mission. Second,
we must improve the management of the agency and hold it accountable. Third, we must
push back against potential industry influence over the agency. And finally, and perhaps
most importantly, we must let the scientists do their work, guided by science and not
political interference. I should say that the Commissioner's budgeted initiatives to
improve the regulatory science capabilities of the FDA are a good step in this final
direction.
These are the four guideposts I have used, and will continue to use, in judging our
progress and in evaluating this FY 2011 budget request. Dr. Hamburg, I look forward to
hearing how you believe the FDA plans to move toward these broad guidelines in the
year to come. And I look forward to hearing how new initiatives, such as the recently
established Center for Tobacco Products, will fit into this vision.
Thank you once again for joining us. I would now like to recognize Mr. Kingston
for any opening remarks he might have.

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