Approving Antibiotics - What's the Problem?
November 30, 2012

In an era of instant-everything, it's hard to understand why we can't develop, research and bring to market new antibiotics for animals that can solve disease issues as well as prevent against antibiotic resistance in the human population. 
 
But while we can instantly upload a video to YouTube for free with a touch of a button on our smart phone, it can take 7-10 years and as much as $100 million to get a new compound approved for food animals in the United States. 
 
Speaking at the 2012 National Institute for Animal Agriculture's Antibiotic Symposium in Ohio, Rich Carnevale, VMD, Animal Health Institute, said bringing a new product to market involves discovery, approval and post-approval. 
 
Consumer media sometimes makes it sound like drugs for food animals are approved willy-nilly, but they don't realize it's a long and arduous process that starts with scientific discovery, preliminary trials, pre-clinical trials, clinical trials, regulatory review, product approval and then monitoring for adverse reactions post-approval. 
 
The Food and Drug Administration approval for antimicrobials involves safety, efficacy and quality. Safety considerations include animals, environment and human food safety. An approval must follow Guidance for Industry #152, which includes determining the potential for resistance selection to impact human health through food. These processes, Carnevale explained, are unique to antimicrobials. 
 
"The process is more complicated for animal drugs than human drugs," he said. 
 
Carnevale shared 2011 data from the International Federation for Animal Health (IFAH), which represents global animal health. IFAH's survey of length-of-time for submission of a new animal drug for food animals to approval showed a mean of 9.4 years, with a range of 7-13 years. In contrast, for companion animals the mean was 6.4 years. 
 
For a food animal pharmaceutical, the average cost was $38.8 million and about $21.6 million for companion animal pharmaceuticals. 
 
The presentations from the symposium are now available online. To listen to the audio of the presentations, go to www.animalagriculture.org/Solutions/Symposia/2012_antibiotics/proceedings.html. 
 
Reprinted in part from USAHA