FDA Told To Act on Farm Antibiotics

From today's WSJ: 

A federal judge ordered the Food and Drug Administration to restart a process that could limit the use of two types of antibiotics in cattle, pigs and poultry, amid concerns such use leads to antibiotic-resistant infections in humans.

In a ruling late Thursday, Judge Theodore Katz in New York said the FDA needed to start the process of no longer allowing penicillin and tetracyclines to be used on livestock for non-medical reasons.

That could wind up materially cutting the amount of antibiotics used in animal feed, addressing a decades-long concern of safety advocates. But the exact outcome remains unclear. Drug makers will be allowed to request a hearing to show that such uses of their products are safe, and any final rule-tightening could get watered down along the way.

In 1977, the FDA concluded that using low doses of penicillin and tetracyclines was not safe, and issued a notice stating it would start the process of withdrawing the approval for use of such drugs for non-medical uses. But it never followed through to stop the practice.

Last year, consumer groups, including the Natural Resources Defense Council, sued the FDA in federal court asking a judge to order the agency to follow through on its 1977 proposal.

In the 1950s, the FDA had approved the use of antibiotics to stimulate growth of cattle, swine and chickens. However, it was later shown that widespread use of antibiotics in livestock can cause the development of drug-resistant bugs that can be transferred from animals to humans.

"For over 35 years, FDA has sat idly on the sidelines largely letting the livestock industry police itself," said Avinash Kar, an attorney at the Natural Resources Defense Council.

"In that time, the overuse of antibiotics in healthy animals has skyrocketed?contributing to the rise of antibiotic-resistant bacteria that endanger human health," he said.

The FDA said it was studying the opinion and considering the appropriate next steps.

Agriculture experts and farmers said many livestock producers have already cut back or eliminated indiscriminate use of antibiotics altogether, and predicted the rule wouldn't change their operations anytime soon.

"A lot of people have the perception that people are using medication without rhyme or reason, and that's not the case," said Lisa Becton, head of swine health information and research for the National Pork Board.

The National Cattlemen's Beef Association, which represents beef producers, said it was disappointed with the court ruling that would require the FDA to use a strict administrative process to regulate antibiotic use.

"Cattle producers work hand-in-hand with veterinarians and animal-health experts each day to implement comprehensive herd-health management plans, which include the judicious use of antibiotics to prevent, control and treat any cattle health issues," the group said.

Leon Sheets, a hog producer, in Ionia, Iowa, said he didn't expect the requirement would change his operations anytime soon. "Antibiotics can be one of those tools" used to manage illness, but farmers already gauge their use in part because of the cost of the drugs, Mr. Sheets said.

Earlier this year, the FDA banned non-medical uses of a class of antibiotics known as cephalosporins, which are sold for human use under brands including Keflex, Ceftin and Cedax, and are used to treat bone, urinary-tract and respiratory infections.

As of April 5, it will become illegal to use the products in healthy animals as a way to help prevent disease, though using them to treat a specific illness will remain legal. Cephalosporins, unlike penicillin and tetracyclines, were never approved by the FDA for non-medical use in animals.