Act will help get affordable medications to ranchers, farmers and pet
owners
WASHINGTON, Aug. 14 /PRNewswire/ -- The Generic Animal Drug Alliance
(GADA) today announced that President Bush signed into law the Animal
Generic Drug User Fee Act of 2008 (Title II of H.R.6432). Under the Animal
Generic Drug User Fee Act (AGDUFA), generic animal health companies for the
first time will pay user fees to provide essential resources to improve
generic animal drug 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
by health insurance. Ranchers, farmers, and pet owners pay out-of-pocket
for prescription medications. In contrast to human medicine where generics
enter the market as soon as a drug's patents expire, few veterinary drugs
have FDA approved generic versions, even years after patent expiry.
Although both new animal drugs and generic animal drugs are reviewed
and approved by the Center for Veterinary Medicine (CVM), the review times
for generic drug applications average more than four times as long as those
for new animal drugs-preventing generic versions of medications that have
long been off patent from getting to veterinarians.
"The success of AGDUFA will allow the review process for generic animal
drugs to become more efficient and predictable while continuing to meet the
rigorous standards for drug approval" stated Stephanie Batliner, Chair of
the Generic Animal Drug Alliance and Director of Regulatory Affairs at IVX
Animal Health, a GADA member company. "Generic animal drugs are essential
to both pet owners and food producers to reduce costs and increase
accessibility to medications."
Jean Hoffman, CEO of Putney, a GADA member company, commented "The
AGDUFA legislation marks the beginning of a new era for animal health. Much
as generics have changed the face of human healthcare-making drugs more
affordable for Americans-the timely availability of animal generics will
help ranchers and farmers manage the cost of caring for our country's food
and production animals, and allow pet owners access to lower cost
medications for their companion animals who are considered members of the
family."
About Generic Animal Drug Alliance
The Generic Animal Drug Alliance (GADA) is an independent professional
trade organization that represents the interests of generic animal health
companies before Federal regulatory agencies and Congress. Member companies
are focused on the development, approval and marketing of high quality
generic drugs for animals and pets-making the cost of care for all animals
affordable for ranchers, farmers and pet owners.
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