New York judge orders FDA to act on animal antibiotics

US Magistrate Judge Theodore Katz in Manhattan issued the order in a ruling filed earlier this week.

 

The decision largely agreed with the arguments of several health and consumer organizations that sued last year, saying the FDA violated federal law by failing to withdraw approval of using penicillin and tetracyclines in animal feed when animal health is not at stake.

 

Katz said the agency must evaluate the safety risks of the drugs and make a finding that they are unsafe or explain why it is refusing to do so.

 

He rejected the agency’s argument that it had addressed the threat from antibiotics by initiating a voluntary program that encourages the industry to use the drugs "judiciously" because public hearings would consume extensive periods of time and agency resources.

 

The magistrate judge criticized the agency’s complaint that the process mandated by Congress to address when a drug is found to be unsafe was not effective because it takes too long, saying it was it was ironic for the agency to make that complaint since hearings would have long been completed had they commenced in a timely fashion.

 

Government lawyers already are appealing a March ruling by Katz in which he required the FDA to withdraw approval for uses of the antibiotics that the industry cannot prove are safe.

 

They have asked Katz and the 2^nd US Circuit Court of Appeals to suspend the effect of his rulings, saying "the unnecessary expenditure of public funds and resources is not in the public interest," especially since the agency is trying through its voluntary program to limit the use of 161 antibiotic drugs rather than the several at stake in the litigation.

 

They added that staging hearings would force the FDA to divert resources from other agency programs that are important to its public health mission and could take years.

 

The FDA declined to comment, citing the ongoing litigation.