Industry groups this week expressed relief as the Animal Drug User Fee Act (ADUFA) was reauthorized without major changes or amendments. The act, which was first enacted in 2003, allows the FDA to collect fees from animal health companies to support testing and approval of new drugs. The fees help reduce the time involved in the review process and speeds approvals for new, innovative products.
ADUFA was due for its five-year authorization this year, and livestock groups had expressed concern that activist groups and politicians opposed to antibiotic use in food-animal production would use the process to advance their agenda. According to the National Pork Producers Council (NPPC), opponents of modern livestock production had threatened to offer provisions to restrict from use in food animal production certain antibiotics and to require reporting of on-farm uses of animal health products. NPPC also notes that FDA already collects antibiotics sales data, which a number of groups have misused in efforts to blame animal agriculture for the rise of antibiotic-resistant illnesses in people.
However, the House of Representatives overwhelmingly approved the legislation on Monday without amendments. The Senate had approved its version of the bill on May 8, and it now goes to the President for his signature.
“Animal medicines play an important role in public health by providing veterinarians, pet owners and livestock producers with the tools needed to keep animals healthy,” said Animal Health Association president and CEO Alexander Mathews. “Reauthorization of ADUFA helps ensure continued access to innovative medicines that allow our pets to live longer, healthier lives and contribute to food safety by keeping food animals healthy.
“We appreciate the bipartisan leadership on both sides of Capitol Hill that made this possible,” Mathews adds.
NCBA had set reauthorization of ADUFA is one of its top policy priorities for 2013. NCBA president Scott George, a dairy and beef producer from Cody, Wyo., says new animal-health technologies allow cattle producers and veterinarians to prevent, control and treat diseases to maintain a healthy herd. “Raising healthy cattle is of utmost importance to cattlemen and women, and it is important for producers and the veterinarians they work with to have the ability to best manage herd health and produce safe, nutritious beef,” George says.
George adds that with a "clean" bill free of amendments, the fees paid by animal health companies to fund FDA reviews and evaluations will be utilized to support and facilitate the new animal drug approval process. "Cattle producers know that keeping our animals healthy is critical to the viability of our operations and our industry," said George. "We sincerely thank the Senate and House leadership for working together to pass this legislation and for realizing the importance of passing a clean bill without unnecessary language or amendments."