The Food and Drug Administration’s (FDA) new guidance document to assist drug sponsors with evaluating the potential for new animal drugs to contribute to antibiotic resistance in humans has received mixed reviews.
The document, Guidance for Industry # 152 (“Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern”), is not a regulation, stresses FDA. Rather the document offers a “science-based process drug sponsors may use when they seek approval of an antimicrobial for use in food-producing animals,” the agency explains.
The Animal Health Institute (AHI), which represents animal health product manufacturers, commended the FDA for releasing the document to provide companies with a road map for how antibiotics will be reviewed.
The new document is a big step ahead of Europe’s approach to phase out the use of antibiotics for growth promotion or to legislation proposed in the U.S. Congress. The new document uses risk assessment and science over politics and looks at drugs individually, instead of lumping them all together, says AHI.
“This risk-based approach will allow FDA to make sound management decisions that protect public health from the potential transfer of antibiotic-resistant bacteria from animals to humans,” says AHI President and CEO Alexander S. Mathews. “At the same time, it will preserve the important benefits of using antibiotics to protect animal health.”
Tom Burkgren, DVM, executive director, American Association of Swine Veterinarians, is concerned there will be scrutiny of existing animal health products for their role in contributing to antibiotic resistance in humans.
“I think there still remains a concern that there is a shift of the balance far toward the issue of human health, without true benefit for human health on this whole issue,” he says.
The guidance document appears to be overly cautious in its final risk evaluation of current animal health products, despite data which shows them to rate low for both actual risk and exposure levels, explains Burkgren.
More information on the FDA document can be found at www.fda.gov/oc/antimicrobial/questions.html.