Groups Urge FDA Not to Appeal Court’s Decision on Antibiotics

BY HELENA BOTTEMILLER 
Sustainable agriculture, animal welfare and consumer interest groups wrote to the U.S. Food and Drug Administration this week asking the agency not to appeal a recent court decision that orders the reconsideration of two petitions on subtherapeutic antibiotic use.

According to the most recent estimates, around 80 percent of all antibiotics sold in the United States – approximately 29 million pounds – are used to promote growth and control disease in food animal production each year, and there’s a growing concern that the practice is contributing to antibiotic resistance among foodborne pathogens and other bacteria.

The FDA has already appealed a March court decision ordering it to rescind feed additive approvals of penicillin and tetracyclines unless drug makers were able to demonstrate they are safe. Advocacy groups – including the The Johns Hopkins Center for a Livable Future, Food and Water Watch, and STOP Foodborne Illness – wrote to the FDA this week urging the agency to not appeal a June decision, which asks the agency to reconsider two petitions from 1999 and 2005 that were recently denied.

The court ruled that FDA did not provide proper legal justification for denying the petitions. The court pointed out that the agency cited cost and time as key reasons not to move forward on the withdrawal proceedings, rather than focusing on safety and efficacy.

“The new decision covers more medically important antibiotics in animal feed than just penicillins and tetracyclines, and more uses of them. Other antibiotics approved for animal feed include, for example, streptogramins, sulfas, aminoglycosides and macrocodes,” the groups explain in their letter to FDA Commissioner Margaret Hamburg.

The groups said that an agency decision not to appeal would not necessarily interfere with the FDA’s current voluntary approach, which encourages judicious use and seeks to bring medically important antibiotics under veterinary oversight.

“This is that rare opportunity when the FDA can do enormous good for public health by doing nothing – at least in terms of not appealing the decision by federal court,” said David Wallinga, of the Institute for Agriculture and Trade Policy, which organized the letter.

The Animal Health Institute, which represents veterinary pharmaceutical companies, argues that the recent court decision “adds confusion to FDA’s efforts to phase in veterinary oversight of antibiotics used in food animals while eliminating growth promotion uses.”

“Animal health companies will continue to support and work with FDA on the stakeholder process to achieve its goals of veterinary oversight and elimination of growth uses for medically important compounds,” said AHI last month. “This cooperative process will help avoid the unintended consequences of increased animal disease that have resulted from legislated bans in Europe.”

 

 

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