FDA Issues New Rule Requiring Drug Companies to Report Amount of Antibiotics Sold For Each Animal Species Used For Meat Production

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Data Will Help Regulators Track Antibiotics But More Is Needed To Curb Drug Overuse

(WASHINGTON, D.C.: May 11, 2016) – The U.S. Food and Drug Administration issued new rules today that will require pharmaceutical companies to estimate the amount of antibiotics they sell by the species of animal used for meat and poultry production. The new reporting requirement aims to help regulators and policymakers better understand the overuse of antibiotics on livestock, which the Centers for Disease Control and Prevention and most public health organizations have warned is making these medications less effective for treating disease in people.

“The FDA’s new reporting requirement is an important step in the effort to rein in the overuse of antibiotics on healthy livestock,” said Michael Hansen, PhD, senior scientist at Consumer Reports. “Until now, we knew how many total pounds of a drug like tetracycline were fed to food animals, but we had no idea whether it was being fed to chickens, cattle, pigs, or turkeys. Now drug companies will have to estimate those sales, species by species, and we may be able to see which industries have reduced use.

Consumers Union had urged the FDA to collect data from veterinarians and feed mills who work with farmers in order to get a more precise estimate of the amount of antibiotics being used for each animal species. Pharmaceutical companies market their drugs for a variety of species and would likely be able to provide just a rough estimate of how much is being used for each one. Last year, California enacted a law that requires the state Agriculture Department to develop antibiotic stewardship programs and gather information on medically important antibiotics sales and usage. The law authorizes the state to collect the data from veterinarians and feed mills.

“More needs to be done to measure the success of antibiotic stewardship efforts,” said Hansen. “Among other steps, the FDA should collect veterinary antibiotic use data. New Veterinary Feed Directive Records will provide accurate data on how much antibiotics are being used on livestock. We urge the FDA, which indicated in its Final Rule that it is considering using these data, to develop a plan as soon as possible for collecting and analyzing it.”

Some 80 percent of all antibiotics sold in the U.S. are used not on humans but on animals. These antibiotics are regularly fed to healthy animals like cows, pigs, and poultry to make them grow faster and to prevent disease in often crowded and unsanitary conditions on today’s industrial farms.

When antibiotics are used on the farm, the bugs that are vulnerable to them tend to be killed off, leaving behind “superbugs” that are resistant to antibiotics. Antibiotic-resistant bacteria can spread from the farm to our communities via meat and poultry, farmworkers, and through the air, soil, and water. As antibiotic resistance increases, the medications used to treat infections in people become less effective.

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Contact: Michael McCauley, mmccauley@consumer.org, 415-431-6747, ext 7606 or 415-902-9537 (cell) or David Butler, dbutler@consumer.org, or Kara Kelber, kara.kelber@consumer.org, both at 202-462-6262