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Statement on Food and Drug Administration's (FDA) Fiscal Year 2000 Budget Request by The Honorable Donna Shalala
Secretary
U.S. Department of Health and Human Services

While I had hoped to be able to address the Subcommittee in person today, I would like to make this statement in strong support of the Food and Drug Administration's (FDA) Fiscal Year 2000 budget request. I greatly appreciate the Subcommittee's long standing support for FDA-related issues.

As the members of the Subcommittee well know, the FDA is the most important consumer protection agency in the world. FDA plays a vital role in protecting the health and safety of our citizens. While FDA has carried out its consumer protection responsibility with great care, its duties have grown over the years. More than ten major new statutory responsibilities have been assigned to this agency since 1990. Moreover, complex new technologies such as gene therapy, tissue transplantation, and anti-viral drugs have posed new challenges for FDA, as have previously unforeseen problems such as AIDS, lethal new food pathogens, drug counterfeiting, and bioterrorism. As a result, virtually all of FDA's programs have come under great stress.

As technology progresses, the demands on FDA will continue to increase. Although it is impossible to predict every public health problem that may arise, a strong, science-based regulatory system can minimize the harm to public health. For this reason, it is fortunate that Dr. Jane Henney is the Commissioner of Food and Drugs. Her commitment to strengthening the science base throughout FDA will help us to solve the numerous public health problems we may face as we move into the next century.

The President's budget for FY 2000 provides for a historic 19-percent increase over FY 1999 funds. Let me highlight a few key areas:

• Injury Reporting: FDA will use the funds to develop and implement a science-based system to improve the quality of information on adverse events associated with foods, drugs and medical devices. Such a system will save lives and lower the estimated $26 billion annual cost to the federal government of these injuries.

• Premarket Review: The Administration is proposing $17 million in additive user fees in addition to $11 million in new budget authority to improve review times for premarket approvals, as directed by statutory requirements. The funds will give FDA the resources needed to review commercially important and life-saving new products in a timely manner. We have achieved great success with the funding provided for drug review, resulting in new drugs entering the market in this country more quickly than anywhere in the world, with no compromise to our traditional high standards. The Administration is involved in discussions with industry, which understands the benefits that they will derive if the Administration's proposal is enacted into law. We believe that, with sufficient funding, we can achieve that goal in other areas. We strongly urge the members of this Subcommittee to support the premarket review user fee proposal.

• Product Safety Assurance: The public expects, and Congress has directed, that manufacturers of foods, drugs, and medical devices be inspected periodically to insure that safety standards are being met. Our budget begins the process of meeting more of these expectations.

• Food Safety: The requested funds will help us accomplish our goal of a truly coordinated and effective food safety net based on sound science. This improved system will help reduce the thousands of deaths annually and millions of illnesses caused by contaminated food.

• Tobacco: FDA will be able to expand efforts to reduce tobacco use among children, including state agreements and contracts to enforce the ban on the sale of tobacco to our youth. Three thousand young Americans begin smoking each day and about one-third of them will die prematurely as a result. The success of this program is critical to reducing these numbers.

Let me point out that, unlike in previous years, there are no "deficit reduction" user fees in our budget. I believe that the funds requested are a sound investment that will save our taxpayers many, many times the amount we are requesting of you. I urge you to support the agency by giving it the resources it needs to carry out its public health mission in the next millennium.