The National Pork Producers Council (NPPC) is urging reauthorization of the Animal Drug User Fee Act (ADUFA), calling it a critical tool needed by pork producers and swine veterinarians.
The law passed in 2003 authorizes the Food and Drug Administration (FDA) to collect user fees from the animal health industry for review and approval of new animal health products.
Legislation to reauthorize ADUFA is expected to be introduced in Congress after a public comment period that ends April 14. The law is set to expire on Sept. 30. It is similar to the Prescription Drug User Fee Act, which underwrites reviews of new drugs for humans.
“Our industry has faced a number of disease challenges since ADUFA was first signed into law,” says Barb Determan, a past NPPC president and pork producer from Early, IA. “ADUFA was able to get new, innovative technologies to the marketplace, which has helped our industry grow and prosper.” Determan spoke recently at a public hearing at FDA’s Center for Veterinary Medicine.
Since ADUFA was signed into law, three new swine health products have been approved for use by the pork industry, helping in the fight against swine respiratory diseases. According to NPPC officials, those include three antibiotics: Excede and Draxxin, both manufactured by Pfizer Animal Health, and Nuflor (feed-grade formulation), sold by Schering-Plough Animal Health. ADUFA does not affect vaccines, since the U.S. Department of Agriculture, and not the FDA, approves them.
The FDA review and approval process for animal health products is very rigorous. Approval requires that animal health companies demonstrate their products are effective and safe for animals and the environment. For products intended for use in food animals, meat from those animals must be proved safe for human consumption.
“We need new and innovative medicines to maintain the health of our pigs and to deliver safe, wholesome meat products to consumers around the world,” stresses Determan. “ As a pork producer, I have a responsibility to protect public health, animal health and food safety. Pork producers need new medicines and technologies to accomplish this.
“ADUFA ensures that animal health companies are able to provide products to treat and control the new diseases that our animals will face,” adds Determan. “The broader public interest is served when pork producers have the means necessary to keep their animals healthy. ADUFA is a critical tool needed by the pork industry and veterinarians.”
A coalition of 17 commodity groups including the NPPC, American Farm Bureau Federation, National Cattlemen’s Beef Association, National Chicken Council and National Milk Producers Federation have sent letters to lawmakers urging quick approval of reauthorization for ADUFA.
Their letter states: “The long-recognized threats of zoonotic diseases, such as foodborne bacteria that can cause illness in people, demonstrate that the need to protect public health by protecting animal health has never been more important.”Reauthorization of ADUFA is supported by the Animal Health Institute, the group which represents animal health company manufacturers.