FDA FY01 Budget

3/31/2000

United States Senate Committee on Appropriations Subcommittee on Agriculture, Rural Development and Related Agencies

Chairman Cochran, Ranking Member Kohl, and distinguished Members of the Subcommittee, my name is Colleen Kelley, and I am the National President of the National Treasury Employees Union. The NTEU represents more than 155,000 federal employees, including those who work at the Food and Drug Administration. I appreciate this opportunity to present testimony to you today on behalf of the men and women who help ensure our foods, drugs, cosmetics, medical devices, and thousands of other consumer products are safe. The actions of this subcommittee directly affect their lives and the livelihoods of every American.

American consumers rightfully depend on their food to be free of bacteria or other food borne diseases. They demand that we find cures for terminal cancer and other deadly diseases. And they expect that consumer products, such as mouthwash, toothpaste, or any other commonly used product imported into the U.S. will not prove to be fatal.

Day in and day out, FDA's scientists, doctors, veterinarians, and support personnel are working to ensure the safety of the American people. From the most basic, but very important, task of educating children about how to handle meats properly to avoid bacteria, to approving new drugs to treat diabetes or depression, FDA employees are working to protect and improve the health of the American people.

Let me share with you a couple of examples of the outstanding work of our FDA employees. One of the most important duties of the FDA field laboratories is to directly respond to local consumer complaints regarding FDA regulated products. Recently a chemist working at the FDA laboratory located in Denver, Colorado helped prevent the death of a man who had gotten violently ill while drinking a soda. This FDA chemist analyzed the soda and found it to be contaminated with barium nitrate. This deadly chemical came from a sparkler, which had been put into the soda. If this deadly chemical had not been accurately identified in a timely manner, the man probably would have died. However, thanks to the analysis and accurate identification of the poisoning by the FDA chemist in Denver, the patient's doctor was able to save the patient by knowing to treat him for barium poisoning.

At our laboratories in San Francisco, Los Angeles, Baltimore, and other laboratories located at or near our nation's ports, FDA microbiologists and investigators work with Customs officials to quickly test and identify harmful foods which are trying to be imported. When the FDA microbiologists determine that the foods pose a risk to American consumers the foods are sent back to where they originated.

In Rockville, Maryland, FDA chemists and scientists are quickly developing and approving safe and effective drugs to help find cures for cancer, AIDS, alzheimer's, and autism. They're working on drugs to help ease the pain of heart burn and treat depression.

On any given day at an FDA laboratory in Missouri or California, FDA scientists could be analyzing over-the-counter drugs for cyanide contamination, examining baby food products for added glass fragments, or analyzing wine for poisonous ethylene glycol contamination.

These are only a mere sampling of the day-to-day activities being performed by the dedicated men and women who work at the FDA. And these are only a few examples of why we need to increase the resources for this agency.

I am pleased that the President has requested a 14.5% increase in funding for the FDA for Fiscal Year 2001. We cannot expect the FDA to continue to carry out its mission and protect the public health, without the staffing and resources necessary to do the job. In particular, I support FDA's request for increased staffing in a number of critical areas, such as the food safety initiative, verifying the safety of domestic and imported products, cracking down on illegal Internet drug outlets, and improving the efficiency and timeliness of the user fee program. These programs, as well as countless others within FDA need additional staff to address the demands of protecting and improving the health of the American public.

The FDA needs increased staffing in order to increase surveillance and inspections of food: food that originates in this country, and food that is imported. And the FDA needs more staff to address the increasing demands to shorten the amount of time it takes to test drugs, ensure their safety, and make them available to patients.

I also want to bring to your attention some concerns I have about the FDA budget. As you know, the FDA is in the midst of a consolidation of its laboratories, which are currently located in key locations across the country. I share the agency's views that we need to significantly improve the quality of FDA's laboratory infrastructure. However, I do not believe that closing certain existing laboratories will necessarily improve FDA operations and capabilities. Our nation cannot afford to lose the knowledge and experience of these scientists who have worked for many years in the FDA field laboratories. However, if any laboratories are closed in the future, I would urge this subcommittee to work to ensure that the FDA minimizes the impact on the current FDA employees who would be affected, and the impact on FDA operations in general.

In addition, I have serious concerns about proposals that have been considered both in Congress and internally at the FDA which would contract out work currently being performed by FDA employees. There is an inherent conflict of interest when a company seeking approval for a drug or food product is the same company granting the approval. I do not believe the American public is prepared to entrust private companies, most of which are driven by profit, to ensure the safety and effectiveness of their drugs and food.

I believe that the FDA FY01 budget request is a good first step, but I believe that the level of funding requested by the FDA should be viewed as a floor, not a ceiling. As the number and complexity of drugs, food products and other FDA regulated goods in the marketplace continues to increase, it is critical that the Congress provide additional funding for staffing at the FDA. While I believe that funding should be used to make technological improvements to FDA laboratories and equipment, I am sure you will agree with me that technology alone cannot possibly address the demands the agency now faces.

I would like to thank the Subcommittee again for the opportunity for our Union to present its views on the budget for Fiscal Year 2001. As you continue your subcommittee's deliberations, I hope you will give special consideration to FDA's dedicated workforce, a team of public servants who have committed themselves to ensuring safe foods, drugs, and medical devices for the American people.