DeLauro Welcomes Commissioner Hamburg Before Agriculture Appropriations Subcommittee

Washington, D.C. – Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, delivered the following opening statement during a subcommittee hearing at which FDA Commissioner Margaret Hamburg testified.

Below is the text of DeLauro's opening statement (as prepared for delivery).

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.