Approving antibiotics – what’s the problem?

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FDA logo 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 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 last week, Rich Carnevale, VMD, Animal Health Institute, said bringing a new product to market involves discovery, approval and post-approval. “It’s difficult to find new compounds that are successful,” he said. “Veterinary compounds are usually derived from the human side, and on the human side only about one in 20,000 discoveries are successful.”

Consumer media sometimes makes it sound like drugs for food animals are approved willly-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 (FDA CVM), product approval (published in the Federal Register), then monitoring for adverse reactions post-approval.

FDA approval for antimicrobials involves safety, efficacy and quality. Safety considerations include animals, environment and human food safety (residues, impacts on gut flora), 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 (range of $20-$100 million, species such as beef cattle on the higher end of the range), and about $21.6 million for companion animal pharmaceuticals.

Ideal antimicrobial
What is the ideal antimicrobial for food animals? Carnevale offered this list:

  • Has quality, is safe and effective and still meets regulatory requirements
  • Has patent protection
  • Is affordable, has an acceptable ROI
  • Has market differentiation from existing products
  • Is not on the critical medically-important list for human use
  • Is bactericidal vs. bacteriostatic
  • Has rapid metabolism and further degradation in excreta or environment

“These qualities are unlikely all to be met, but are desirable,” Carnevale said.

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Dieter Harle    
Bettendorf, IA 52722-6100  |  November, 20, 2012 at 09:42 AM

It his high time we do not focus only on new products. We must look at where we are coming from and what are some of the real causes of unexplainable (death) losses that do get swept under the carpet for economical reasons. I suggest we look at wider circles instead of just the cause. Underlying reasons - secondary linkages and interferences like with the alteration of genetically engineered crops. Amino acids have been changed and the plants and seeds while appearing the same are actually quite different as this "new" feed stuff has now a different nutrient profile and absorption reaction. Trace minerals and enzymes in food has changed and to some extent are lower and in different ratios today. Let's be more open what "others" see and have research about. Look outside of the box! Why spend money on negative advertising! It is not an approval or legal issue, it simply needs to be evaluated what is truly biological and fully understood - not just proof of a small spectrum hypothesis. While funding is always critical, "purchased" research should not become public opinion without complete analysis and discussion. Basic research and teaching must be separated from private or corporate interest driven research. Universities and Land-Grant Universities need to recognize and separate these issues in particular for biological research. Partial positive results should not become positive solutions because there will be partial negative results and those cannot be excused or written off with risk management strategies.

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