WASHINGTON, Aug. 14 The Generic Animal Drug Alliance(GADA) today announced that President Bush signed into law the Animal GenericDrug User Fee Act of 2008 (Title II of H.R.6432). Under the Animal GenericDrug User Fee Act (AGDUFA), generic animal health companies for the first timewill pay user fees to provide essential resources to improve generic animaldrug review times-getting high quality, affordable generics to veterinarians,and animal and pet owners, faster.
Farm animals and livestock, and the majority of pets, are not covered byhealth insurance. Ranchers, farmers, and pet owners pay out-of-pocket forprescription medications. In contrast to human medicine where generics enterthe market as soon as a drug's patents expire, few veterinary drugs have FDAapproved generic versions, even years after patent expiry.
Although both new animal drugs and generic animal drugs are reviewed andapproved by the Center for Veterinary Medicine (CVM), the review times forgeneric drug applications average more than four times as long as those fornew animal drugs-preventing generic versions of medications that have longbeen off patent from getting to veterinarians.
"The success of AGDUFA will allow the review process for generic animaldrugs to become more efficient and predictable while continuing to meet therigorous standards for drug approval" stated Stephanie Batliner, Chair of theGeneric Animal Drug Alliance and Director of Regulatory Affairs at IVX AnimalHealth, a GADA member company. "Generic animal drugs are essential to both petowners and food producers to reduce costs and increase accessibility tomedications."
Jean Hoffman, CEO of Putney, a GADA member company, commented "The AGDUFAlegislation marks the beginning of a new era for animal health. Much asgenerics have changed the face of human healthcare-making drugs moreaffordable for Americans-the timely availability of animal generics will helpranchers and farmers manage the cost of caring for our country's food andproduction animals, and allow pet owners access to lower cost medications fortheir companion animals who are considered members of the family."
About Generic Animal Drug Alliance
The Generic Animal Drug Alliance (GADA) is an independent professionaltrade organization that represents the interests of generic animal healthcompanies before Federal regulatory agencies and Congress. Member companiesare focused on the development, approval and marketing of high quality genericdrugs for animals and pets-making the cost of care for all animals affordablefor ranchers, farmers and pet owners.
SOURCE The Generic Animal Drug Alliance