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Statement on Food and Drug Administration's (FDA) Fiscal Year 2000 Budget Request by The Honorable Donna Shalala
U.S. Department of Health and Human Services
Before the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies
April 27, 1999
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
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.
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
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
- 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
- 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
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.