Bloomberg News

Superbug Rise Spurs New Rules

April 11, 2012

Farmers will need prescriptions to get antibiotics for their livestock and the drugs should only be given when medically necessary to avoid overuse that can foster resistance, U.S. regulators said today.

The Food and Drug Administration also suggested in three papers released today that drugmakers change their labels to remove production uses of antibiotics, including for weight gain and accelerated growth. Even though farmers will need prescriptions for the antibiotics, they aren’t bound by the new guidelines to restrict nonmedical uses of the drugs.

Foodborne outbreaks from pathogens that are resistant to antibiotics have sickened 19,897 people and killed 26 from 1973 to 2009, according to the Center for Science in the Public Interest, a Washington-based consumer advocacy group. The agency said it has asked drugmakers to phase in the label changes removing the use of antibiotics for growth promotion and including veterinary consultation on the medicines.

“The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective,” FDA Commissioner Margaret Hamburg said in a statement.

A draft document the agency released today outlines ways that veterinarians can authorize the use of certain animal drugs in feed for health reasons. Prescriptions already are required for some antibiotics used mostly in injected forms and not in animal feed, said Siobhan DeLancey, an FDA spokeswoman.

Label Change Guidelines

Another draft guides drugmakers in voluntarily removing the production uses of antibiotics from their FDA-approved labels and adding veterinary consultation. The agency has a commitment from companies to voluntarily change their labels, Michael Taylor, deputy commissioner for foods at the FDA, said on a telephone call with reporters. Pfizer Inc. (PFE:US), based in New York, Eli Lilly & Co. (LLY:US), based in Indianapolis and Merck & Co. (MRK:US), based in Whitehouse Station, New Jersey, have animal health units, though Pfizer has indicated it will sell its division.

Drugmakers should be able to implement label changes within three years of FDA finishing the guidance released today. The agency said it plans to release a final document about the end of this year.

Bacteria can mutate in ways that make them resistant to treatments and pass those traits to offspring or other microbes. A pathogen with multiple immunities takes more time and more powerful drugs to control.

Voluntary Approach

A voluntary approach will lead to faster results and prove more effective, Taylor said in February. Another option, rescinding approval for drugs used in livestock, is a laborious and time-consuming process, he said.

The American Meat Institute, the Washington-based trade association for packers and processors of meat and poultry, said in a statement it is reviewing the guidance and will work with the FDA.

“The goal of giving veterinarians greater oversight of antibiotic use in food animals is commendable, but cattlemen are concerned with the feasibility of implementing the veterinary feed directives given practical hurdles,” said Tom Talbot, chairman of the National Cattlemen’s Beef Association’s cattle health and well-being committee, in a statement.

The National Pork Producers Council, which represents 43 state associations, has said producers are voluntarily curtailing drug use and taking other steps to prevent disease. Requiring veterinary approval for animal antibiotic use will disproportionately affect small producers because they have limited access to the services, the council said today in a statement. The FDA acknowledged the potential hurdle and said it is interested in hearing comments on how to overcome it.

Consumer Response

Consumer groups say allowing the industry to police itself will fail. Advocacy groups have filed lawsuits and petitioned U.S. agencies to establish firm mandates to curb antibiotic use in agriculture.

“Industry is not required to do anything,” Avinash Kar, an attorney for the Natural Resources Defense Council, wrote today on the New York-based environmental group’s blog. “This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health.”

Laura Rogers, director of the Pew Campaign on Human Health and Industrial Farming, called the FDA’s move today “the most sweeping action the agency has undertaken in this area,” and said the voluntary nature requires that if the new guidelines don’t bring down antibiotic use, the agency should do more.

A lawsuit the National Resources Defense Council brought in federal district court in New York last May seeks to limit certain antibiotics in the food of animals that aren’t ill, known as subtherapeutic use.

A strain of potentially deadly antibiotic resistant bacterium known as MSRA, or staph, has jumped from food to humans, according to a Feb. 21 study led by the Translational Genomics Research Institute, a Phoenix, Arizona based nonprofit that does research on genetic components of diseases.

To contact the reporter on this story: Stephanie Armour in Washington at sarmour@bloomberg.net; Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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