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Statement on the President's FY 2000 Budget Request for FDA by Donna Shalala
U.S. Department of Health and Human Services

Before the House Agriculture Appropriations Subcommittee
February 23, 1999

Although I was unable to appear today before this Subcommittee on the Food and Drug Administration's (FDA or Agency) Fiscal Year 2000 budget request, I would like to submit this statement for the record.

As you know, Mr. Chairman, the FDA is the most important consumer protection agency in the world, and is responsible for insuring the safety of an enormous variety of products our citizens use every day of their lives. FDA has carried out that mission with great care for the public health. But we and the public have asked much of the Agency in recent years. Indeed, FDA's workload has soared--in such major areas as product marketing applications, reports of injuries from approved drugs and medical devices, and imported foods and drugs. Complex new technologies such as gene therapy, tissue transplantation, anti-viral drugs and human cloning have come to the Agency, as have new challenges that were unforeseen in the past--such as AIDS, BSE, lethal new food pathogens, drug counterfeiting, and bioterrorism.

This necessary attention to new areas, along with passage of more than 10 major new statutory responsibilities given the Agency since 1990, has put virtually every program in FDA under great stress. For example, FDA's food inspections are down from 21,000 in 1981 to 5,000 today; drug and device firms are not inspected in the timeframes directed by Congress; fewer than 1% of imported foods are examined by FDA inspectors; adverse event reports that tell us of hidden dangers in marketed products go unread; and many products go virtually unregulated (such as dietary supplements, cosmetics, and medical products purchased from foreign countries).

The President's budget request for FY 2000 is intended to begin a fundamental rebuilding of an agency, and it's science base, that is so important to the health and well being of our citizens. We are requesting an 18% increase over FY 1999 that can achieve very substantial accomplishments in protecting public health. Let me highlight a few:

o Food safety is a compelling public health issue and is a critical responsibility of my department. The thousands of annual deaths and millions of illnesses that our citizens now suffer from contaminated food should be intolerable to us, and the requested new funds will reduce a persistent hazard and save the public billions of dollars in preventable health care costs.

o Errors in the use of drugs and medical devices cause thousands of deaths and injuries that could be prevented if those incidents are properly recognized and acted upon. The new funds requested will allow us to begin developing an effective injury reporting system that will save lives and lower the estimated $26 billion annual cost of these injuries.

o Commercially important and life-saving new products are being delayed by FDA=s inability to apply the necessary scientists to premarket review. FDA proved that getting sufficient resources for product review can result in great success, as the new funding you provided for drug review has resulted in new drugs entering the market here faster than anywhere in the world, with the same high standards the public expects.

o 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. But the funds have not been provided for this product safety assurance, and our budget begins the process of meeting those expectations.

o Lastly, I do not need to remind you that 3,000 young Americans begin smoking each and every day, and that one-third of them will die prematurely as a result. I urge you to increase funding for our program of state grants to enforce the ban on the sale of tobacco to our children.

I know that in recent years the presence of deficit reduction user fees has been a deterrent to increased funding for FDA. There are no such fees in this budget. The budget is targetted toward critical public health needs, and if the funds are appropriated, they will return the investment many times over.

There is certainly some good news to report. I am sure the Subcommittee will agree with me that Dr. Jane Henney's appointment as the new Commissioner of Food and Drugs gives us all great encouragement about the prospects for FDA's success in the future. I believe that she is the right person at the right time to strengthen FDA's scientific capabilities and move it into the next century. And our FY 2000 request will support the priorities for the agency that she intends to you about when she testifies before you. I urge you to give her the tools she needs to get this important job done. Thank you.

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