DeLauro Welcomes Dr. Sharfstein Before Agriculture-FDA Appropriations Subcommittee

Focuses on reforms to ensure agency fulfills its regulatory mission to protect public health

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 on the proposed Fiscal Year 2010 budget request for the Food and Drug Administration, at which Dr. Joshua Sharfstein, Principal Deputy Commissioner and Acting Commissioner of the Food and Drug Commission testified. DeLauro focused on the agency’s funding needs to ensure it is able to fulfill its mission protect public heath – to ensure the safety of the food people eat, the drugs they take, and the medical devices they rely on.

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

The hearing is called to order. Good afternoon. I want to welcome everyone, particularly Dr. Joshua Sharfstein, Principal Deputy Commissioner and Acting Commissioner of the Food and Drug Commission.

I am pleased again to welcome all my colleagues and the ranking member, Mr. Kingston, as we continue these hearings on the Fiscal year 2010 Agriculture Appropriations bill.

Dr. Sharfstein, I want to welcome you and congratulate you on your new position. I look forward to collaborating with you and Commissioner Hamburg in the months and years ahead. I had an opportunity to meet with Dr. Hamburg yesterday – it was productive, a positive dialogue.

I know you agree the FDA’s first responsibility is to the American people – to ensure the safety of the food they eat, the drugs they take, and the medical devices they rely on. That is the agency’s most fundamental regulatory mission. The American people must be able to depend on the system and the people in charge of protecting them.

I am proud that since taking the chair of this subcommittee we have begun to address that critical need for more resources. This committee and Congress have increased the FDA’s total budget by more than $572 million since 2006.

In 2009, FDA has 39% more in discretionary resources than it had in 2006 – $572 million – despite overall spending limitations imposed by the previous Administration. On top of that, a supplemental appropriation in 2008 of $150 million.

I am proud that since September 2008 the agency has been able to hire 1500 new employees – scientists, inspectors, and analysts doing critical work – a direct result of those increased resources.

Looking ahead to 2010, I am encouraged by the administration’s $2.3 billion request for discretionary resources provided by this Committee, an increase of $299 million, almost 15 percent over last year. I believe this is a good start at giving FDA what it needs to get back on track. It represents a strong commitment to building on the historic levels of investment this committee has made over the last three years.

Dr. Sharfstein I know you have already begun working to connect these recent increases in resources to concrete positive public health outcomes and I encourage you to continuing making them a priority.

But as you know, the problems at the FDA will not be solved simply with more funds and stop gap measures. As you know Dr. Sharfstein, you are coming into an agency desperate for fundamental reform. When we look at recent headlines – unsafe foods and dangerous medical products slipping through the cracks time and again – and it is hard not to see a system in crisis and an FDA hobbled by a fragmented structure, with outdated legal authorities in many areas and insufficient authority to protect the American people.

To restore the agency’s gold standard mission and ensure the fundamental safety of the food and drugs it regulates, I believe we must be guided by four principles.

· First we must 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 the influence of the industries over the agency.

· Finally, and perhaps most importantly, we must let the scientists do their work, guided by science and not political interference.

These are the guideposts I will use in judging our progress as we move forward in the new administration. This is our opportunity to get the big things right for the American people – to make real changes that will affect their health and safety everyday.

With that in mind I want to raise a few issues that I imagine you will discuss in your statement and I may ask you to elaborate on when we get to questions.

In particular, I commend your decision to exclude from the budget fees from industry to finance the agency’s direct-to-consumer television ads. I have always been of the view that having drug companies pay for the review of such ads – and having reviewers' salaries dependent on drug company fees – will further undermine the public's confidence in FDA.

By the same token, I would like to hear more about your proposal to increase the number of generic drugs in the market and how you view the role of generic drugmakers in this expansion.

I also know the FDA must frequently confront new and growing demands in a constantly evolving public health environment. As you know the House recently passed very important legislation giving the FDA responsibility for Tobacco regulation, and the Senate is marking up their version as we speak. I look forward to hearing your strategy for implementing these regulation and discussing how you envision that responsibility fitting within the agency’s overall public health and safety mission.

In the same spirit, I also know you will update us on FDA's approval of a new plant to make seasonal influenza shots that could also be used to make an H1N1 vaccine. Indeed since the virus’s outbreak much of our public health infrastructure, including the FDA has been put to the test. I want to commend you and all of the outstanding scientists and doctors for their quick and thoughtful response so far. I am curious to learn what we are learning from this experience. What new demands has this outbreak created and how will our response going forward affect the agency’s larger mission?

I want to thank you again for joining us Dr. Sharfstein. I look forward to asking you about these and other efforts within the FDA. As I told Secretary Vilsack last week, our appropriations reflect our priorities as a nation. We have big goals and it is the details – the budget and the basics we are discussing here today – that get us there. With that, I would recognize Mr. Kingston for any opening remarks he might have.