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Minor Use and Minor Species Animal Health Act of 2003

Location: Washington, DC


Mr. KENNEDY. Mr. President, I support both of the important provisions in this legislation, the Minor Use and Minor Species Animal Health Act and the Food Allergen Labeling and Consumer Protection Act.

Veterinarians now treat many animals with drugs approved for other animals or even for humans. Such use is sometimes illegal, and it is not always guided by the best evidence available on the safe and effective use of the drug in particular species. The animal health legislation will provide new ways for drugs for minor uses and minor species to become available to treat animals for which very few drugs are now approved.

The bill allows conditional approval by the Food and Drug Administration of all minor use drugs and minor species drugs. It also permits the use of unapproved drugs, if they are for use in nonfood producing minor species, and in certain circumstances, even in the early life stages of food-producing minor species. Safeguards are included so that these drugs will be safe for humans, just as any other animal drug must be safe for humans, and will not lead to antibiotic resistance in humans.

The legislation also allows new animal drugs to become "designated new animal drugs," for which research grants and 7 years of market exclusivity will be available if they are approved or conditionally approved by the Food and Drug Administration.

Overall, this title of the bill will help to improve the health of family pets, zoo animals, and farm animals, and I commend Senator GREGG and Senator SESSIONS for their leadership in developing this legislation and enabling the Senate to consider it today.

The second title of the bill will give families greater confidence that the food they eat is safe. Under the Food Allergen Labeling and Consumer Protection Act, 7 million Americans with food allergies will be able to identify a product's ingredients more easily and avoid foods that may harm them. One-hundred and fifty Americans die each year from food allergies, and this legislation will greatly reduce that number.

It requires the labels on food packages to identify ingredients related to one of the eight main food allergens, and to do so in easily understood words. The FDA is required to provide for "gluten-free" labels on foods, to help people with celiac disease avoid the glutens that cause their disease.

The bill also requires the Centers for Disease Control and Prevention to monitor deaths related to food allergies, and directs the National Institutes of Health to develop a plan for research on food alleries.

I commend Senator GREGG and my colleagues on the HELP Committee for their leadership on this title as well, and I urge the Senate to approve this legislation.

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