FDA role, Solomon looks at importance of FDA in animal production

Washington, D.C. – During the National Cattlemen’s Beef Association and Public Lands Council Annual Legislative Fly-in, held during the first week of April 2018, cattlemen and women from across the country gathered in Washington, D.C. to network with agency officials and Congressional delegations to develop relationships and help both parties gain insight into the other’s lives. 

As one aspect of that effort, Steve Solomon, director of the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM), overviewed his role at FDA and provided insight on the importance of FDA in food animal production. 

“We have an office of management and administration functions, an office that evaluates drugs to get new products on the market, an office in charge of surveillance of compliance and an office of research that develops new products, particularly for minor species,” Solomon explained, emphasizing that FDA’s CVM is multi-faceted and provides a variety of roles. “At CVM, we have a lot of different scientific disciplines, and we have expertise in many areas because we want to make sure our decisions are sound.” 

ADUFA

One important aspect of CVM is oversight of ADUFA, or the Animal Drug User Fee Act, which provides significant impact to animal agriculture producers. 

“Prior to the authorization of user fees, it took an average of 500 days to get approval for new drugs,” Solomon explained. “We’ve reduced that time with the addition of those fees, and those resources are critical to evaluating new drugs.”

The act is reauthorized every five years, and Solomon noted, without reauthorization by October 2018, they will be forced to “stand by” on approval and review of new animal drugs, which could be detrimental to the animal drug industry.

As an example of a new drug that has emerged after testing at CVM, Solomon looked at the first pain relieving drugs for food-producing animals. 

“We all know there are more animal welfare concerns, and to have a drugs approved for use in food-producing animals is a significant advantage,” he explained.

The process of approving such a drug was innovative and required researchers to understand how much pain animals are in to provide adequate treatment for animals.

“This took a very innovative approach to work with sponsors and put products in the hands of people,” he explained.

Technology

Another area Solomon highlighted was the area of new discoveries in animal biotechnology.

“We have new technology for gene editing, and we have drugs for humans that are biopharmaceuticals,” he said, listing several examples. “We have goats that produce drugs in their milk, which is harvested and given to humans to treat certain blood conditions. We have drugs produced by chickens, whose eggs are processed and fed to humans.”

CVM is responsible for oversight on these new products to ensure animals are safe and the gene editing does not result in negative effects for animals. 

“My colleagues in FDA look at the human components, but we prove these technologies are safe for animals,” Solomon said.

He added, “These are innovative products and innovative solutions to big problems.”

Resistance

Another area CVM takes responsibility over is antimicrobial resistance, which has become a buzzword in the U.S. today.

“The Centers for Disease Control reports that 2 million illnesses annually are from bacteria resistant to antibiotics, and 22,000 deaths are from antibiotic-resistant bacteria,” Solomon said. “Antimicrobial resistance results in an estimated cost of $25 to $35 billion.”

Solomon added the livestock industry is working to slow the spread of antimicrobial resistance. 

“This isn’t just a U.S. problem, and it isn’t just an animal health problem,” he commented. “This is an international problem, and we’re addressing it from multiple aspects.”

Solomon said CVM is part of a broad effort to look at both human and animal aspects of antimicrobial resistance, through improved tests for better diagnostics and better international collaboration.

“Different parts of the world are addressing the world differently,” he said. “We’re advocating for a process that we think makes sense because some parts of the world address the problem very differently. This can be challenging.”

Solomon added, “Our understanding of science continues to evolve, and we continue to learn more about antimicrobial resistance. This is a complex issue that too many people try to simplify into simple answers. That is not the case.”

CVM is working as part of a team to implement measures and show concern to make sure antimicrobials are available for treatment, control and prevention with good stewardship. 

“Our role is to slow the role in which resistance occurs by judiciously using antimicrobials,” Solomon said. “We have to work together to address this issue.”

Solomon also looked at the importance of a vaccine bank for foot and mouth disease (FMD). Look for more on FMD in next week’s Roundup. 

Saige Albert is managing editor of the Wyoming Livestock Roundup. Send comments on this article to saige@wylr.net.