Jan. 4 (Bloomberg) -- U.S. regulators said they will restrict certain antibiotics in livestock and fowl to prevent humans from developing resistance to drugs such as Bristol-Myers Squibb Co.’s Cefzil and Keflex from Eli Lilly & Co.
An order issued today by the Food and Drug Administration bars most unapproved veterinary uses of the medicines in cattle, swine, chicken and turkeys, the agency said in a statement. The rule will take effect April 5.
The antimicrobial drugs can only be used to treat animal illnesses “under specific conditions,” and can’t be used for disease prevention, said Siobhan DeLancey, an FDA spokeswoman, in an e-mail. Cefzil and Keflex are available in generic form. Antibiotic injections into unhatched chicken eggs are among uses prohibited by the order.
“We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals,” said Michael Taylor, the FDA’s deputy commissioner for foods, in the statement.
The antibiotics known as cephalosporins are used to treat pneumonia, skin infections, pelvic inflammatory disease, diabetic foot infections and urinary tract infections in humans, the agency said.
Rabbits, Ducks Exempt
Unlike a 2008 FDA order that would have banned all unapproved cephalosporin use in food animals, today’s measure provides exceptions. The restrictions don’t apply to “minor species” of food animals such as rabbits and ducks, and veterinarians can treat all livestock with an older type of cephalosporin called cephapirin that the FDA said is unlikely to fuel antibiotic resistance.
The July 2008 order, rescinded three months later, drew more than 170 comments from the public, DeLancey said.
“We took a step back, revoked that order, looked at comments and science and data, and we realized we could do another order that was just as protective to public health but allowed for some uses for treated animals,” she said.
Today’s action will help preserve the effectiveness of antibiotics that treat severe childhood illnesses including bacterial meningitis and bone infections, said Robert Block, president of the American Academy of Pediatrics in Washington.
“We really don’t have a wide range of antibiotics to use for those, so we fall back to cephalosporins, which are reliable and well tested in kids,” Block said today in an interview. Pediatricians have pressed for restrictions on antibiotic use in food animals for years, he said.
‘Modest First Step’
The FDA’s move is “clearly warranted, but the question is, is it really enough?” said Caroline Smith DeWaal, food safety program director at the Center for Science in the Public Interest, in an interview. “It’s not the last step they need to take.”
The order is a “modest first step,” said Representative Louise Slaughter of New York, senior Democrat on the House Rules Committee.
“We’re really just looking at the tip of the iceberg,” said Slaughter, a microbiologist who introduced legislation in 2009 to prevent the overuse of antibiotics including cephalosporins. “We don’t have time for the FDA to ploddingly take half measures.”
Cephalosporins are important treatments for sick pigs and the agency’s order preserves that use, said Liz Wagstrom, chief veterinarian at the Washington-based National Pork Producers Council. The U.S. pork industry doesn’t use the drugs in animal feed, or “for production uses such as improving nutritional efficiency,” she said.
“We are pleased that FDA considered the extensive comments they received and that they also considered the need to protect animal health while addressing the concerns they had with the potential selection of resistant strains of bacteria,” Wagstrom said today in an e-mail.
Antibiotics are used sparingly in U.S. chicken production, and only if they are approved by the FDA, said Tom Super, vice president of communications for the National Chicken Council in Washington.
The new restrictions may “take medical decisions to treat animals out of the hands of veterinarians,” Super said in an e-mail. “We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans.”
There is no conclusive scientific evidence that “judicious” use of antibiotics by the beef industry leads to drug resistance in humans, said Kristina Butts, executive director of legislative affairs at the National Cattlemen’s Beef Association in Washington. The FDA’s 2008 cephalosporin restrictions weren’t based on sound science, she said in an e-mail.
“As the largest and oldest national organization representing America’s beef producers, we will carefully analyze this proposed order to ensure it is based on science and will not negatively affect the ability of veterinarians and cattlemen to work together to prudently care for animals,” Butts said.
The preponderance of scientific evidence suggests that antibiotic use in livestock is “a big problem that is affecting human health,” said Kathleen Young, executive director of the Alliance for the Prudent Use of Antibiotics, a research and advocacy group based at Tufts University in Boston.
“It’s estimated that 75 to 90 percent of antibiotics used on food animals are excreted into the environment and can be found in soil and ground water at industrial farms, and in food crops,” Young said in an interview. The FDA rule will help ensure that lifesaving medications continue to work in humans, she said.
The FDA and Agriculture Department have made “limited progress” in addressing antibiotic use in food animals, the Government Accountability Office said in a September report. The agencies should identify ways to collect detailed data on veterinary uses, and obtain better statistics on resistance trends, said the GAO, the investigative arm of Congress.
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