Dr. Bernadette Dunham, the next director of the Food and Drug Administration's Center for Veterinary Medicine (CVM) and first woman to serve in that role, believes the times facing veterinary medicine are challenging, yet usher in great opportunity.
From predictions about 2008 to her goals for the agency that approves veterinary pharmaceuticals in the United States, Dunham spoke recently with DVM Newsmagazine.
In January, Dunham was named CVM's director, while 13-year-FDA veteran Stephen Sundlof, DVM, PhD, moved over to lead FDA's Center for Food Safety and Applied Nutrition.
Her first crisis hit less than two months into the job.
In the wake of the beef recall, at least two members of Congress have called for a new department that would consolidate duties split between FDA and USDA. Critics charge a tougher system needs to be in place to prevent sick or downer cattle from entering the food supply especially considering risks associated with an outbreak of bovine spongiform encephalopathy.
The latest incident preceded the anniversary of last year's blockbuster pet-food recall, ending in a series of indictments and long-range plans to build out laboratory networks to minimize the threat next time.
"Now more than ever we are going to be active in helping people embrace risk awareness, risk assessment and risk communication," she says.
"Ever since we had the melamine recall, it opened up the implications of what happens with ingredients that go into pet food. You saw how it extended out and actually went into animal feed. One more step and it potentially may have impacted human food."
Even after the crisis, critical issues and weaknesses within the animal-health framework were exposed.
Take for example, international trade with China. A tainted ingredient was imported into Canada, processed and exported to the United States, and then used in variety of pet foods from many manufacturers.
"We already have a Memorandum of Understanding with China, and that will take us further as we develop and reinforce where we are going to ensure food and the role CVM will play in this new era."
Pet-food labeling might be one example of reforms.
CVM wants to build collaboration with processing and ingredient standards and labeling for pet foods. The center is working on an early warning surveillance and notification system that will help in the event of another recall, large or small.
"It is going to bring together a lot of interaction with all the stakeholders. That is when you get the best of the best, and it will really help all of us," she adds.
"We will continue to interact with our partners – whether it is pharmaceutical companies, veterinary groups, public at large or owners of all of our food animals. CVM does not work in a vaccum."
The end result, she adds, will be a stronger system designed to help prevent future crisis.
"Yes. We were reactive at that time. We hope in the future to be preventive and be able to respond and intervene appropriately."
"In the face of all of it, we still managed to do the most important thing that FDA does, we had to get these products off the market as soon as possible," she says.
Her other challenge is to move products to market as expeditiously as possible. From the time of discovery to ultimate FDA clearance, the agency's process is measured in years — decades in some cases.
"When a pharmaceutical company takes a molecule through the approval process, it takes many years. There are different times of where these compounds are in the pipeline. You may have a year when many drugs just happen to come all the way through and you see a higher rate of approvals."
While she hopes the same holds true for 2008, she stopped short of predicting the level of FDA approvals for the veterinary market.
"We have seen a wonderful benefit that truly has happened from the user-fee program that allowed us to try to do a catch up on the backlog."
CVM brought on new reviewers to help improve the system. She believes the efforts will streamline the process long term.
And she remains bullish on the prospects for animal health driven by increasing consumer expectations and demands.
The greater the love consumers express toward their pets, the greater the opportunity for veterinarians and the animal-health market, Dunham adds.
"We are seeing a huge change with the public and what they expect. They want the best treatements and new therapies for their pets. It gives veterinarians an exciting challenge to deliver on owner expectations."
New drug modalities emerging from biotechnology and pharmacogenomics will help veterinarians hone therapeutic options, Dunham says. Improved screening diagnostics could offer new ways to stave off adverse drug events. An example? P-glycoproteins. There is a mutation that enables certain breeds (Collies) to react to avermectins. A screening test developed to predict hypersensitivities to the compound prior to administration would help. Thanks to the decoding of the canine genome, advanced screening tests are closer to reality.
"It is going to happen more and more as we begin to learn more and more about the genetics behind some of these problems."
Nanotechnology and novel cancer therapies will all play an important role in animal health.
"We are seeing new medications coming through where pharmaceutical companies are seeking approval." And that's good medicine for the entire market.