FDA Reverses Order on Animal AntibioticsDec 10, 2008 | Parker Waichman LLP
Federal health regulators have change their minds about the use of some antibiotics in food-producing animals. On November 25, the U.S. Food and Drug Administration (FDA) revoked a prior order that prohibited the “extralabel” use of certain animal antibiotics that would have taken effect on November 30.
Extralabel drug use refers to the use of a veterinary drug in a manner for which it was not approved, similar to off-label drug use in human medications. Extra-label drug use occurs when a drug only approved for human use is used in animals, when a drug approved for one species of animal is used in another species, or when a drug is used to treat a condition for which it was not approved. Only veterinarians are allowed to prescribe drugs extra-label.
The Wall Street Journal (WSJ) reports that the FDA’s submission this year to ban extralabel uses of cephalosporin antibiotic drugs in “food-producing” animals such as cows, swine, and chickens met with industry criticism. For instance, noted the WSJ, some agriculture groups and animal-drug makers—Pfizer, for one—argued that the drugs are necessary for infectious disease prevention in animals.
Now, the FDA is revoking its earlier regulation and has announced it will allow cephalosporin use in these animals, despite that it called such use a public health risk this summer, notes the WSJ. Meanwhile, some experts—including the American Medical Association (AMA)—are concerned over the potential for antibiotic resistance, which has long been linked to antibiotic overuse and which is known to endanger human life.
Cephalosporins treat respiratory diseases in cattle and swine, said the WSJ, which added that extralabel uses of the drugs include nonFDA-approved uses in poultry and also for non-approved uses in livestock for infectious diseases.
This summer, said the WSJ, the FDA discussed launching an attack on the extralabel use of drugs in animals, specifically noting "the importance of cephalosporin drugs for treating disease in humans." The FDA echoed its concerns again in the fall when its director of veterinary drugs, Steven Vaughn announced, "We have [bacterial organisms] moving around the world that we have never seen before," the WSJ quoted, citing Dairy Herd Management magazine. The WSJ noted that Vaughn discussed the increased prevalence of antibiotic-resistant bacteria in cattle.
The WSJ reported that some industry groups, such as the Animal Population Health Institute, the Kansas Health Department, and the National Turkey Federation, argued against the FDA’s proposed ban and that the American Veterinary Medical Association complained to the FDA that it used flawed data to support the ban. Meanwhile, said the WSJ, the group Keep Antibiotics Working, which supports agriculture-production changes, criticized the FDA's revocation. "They were under a lot of pressure from companies and agriculture, the producers, to end the ban," the organization's chief, Steven Roach told the WSJ.
In June, noted the WSJ, the FDA issued another unexpected announcement and allowed Wyeth's heartworm drug ProHeart 6 to return to the market following controversy in which it was linked to about 500 dog deaths. The drug was withdrawn in 2004.