NEW YORK (July 24th, 2014) – In a 2-1 decision, the U.S. Second Circuit Court of Appeals ruled today that the U.S. Food and Drug Administration (FDA) does not have to consider banning the practice of regularly feeding antibiotics to animals that are not sick despite its finding that such misuse of antibiotics threatens the effectiveness of essential human medicines. The appeals court overturned two district court rulings in cases brought by the Natural Resources Defense Council (NRDC) and other groups, which directed the FDA to stop the routine use of certain antibiotics in healthy animals unless drug manufacturers proved the safety of such use.
In his dissent, Judge Robert Katzmann said, “Today’s decision allows the FDA to openly declare that a particular animal drug is unsafe, but then refuse to withdraw approval of that drug. It also gives the agency discretion to effectively ignore a public petition asking it to withdraw approval from an unsafe drug. I do not believe the statutory scheme can be read to permit those results.”
NRDC brought the lawsuit with its partners, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists in May of 2011. The district court rulings were issued in New York in March and June of 2012.
Following is a series of statements from NRDC and its allies:
“This decision allows dangerous practices known to threaten human health to continue,” said Avinash Kar, attorney with NRDC’s health program. “Adding antibiotics to farm animals’ feed, day after day, is not what the doctor ordered and should not be allowed.”
“This decision effectively gives FDA free rein to ignore science when it’s not convenient,” said Mae Wu, NRDC attorney. “Nevertheless, we will continue to evaluate all legal and policy avenues to end the dangerous overuse of antibiotics in farm animals.”
“The misuse of antibiotics in food animal production contributes to the epidemic of antibiotic resistance in our hospitals and communities,” said Robert S. Lawrence, MD, director of the Johns Hopkins Center for a Livable Future and a professor with the Johns Hopkins Bloomberg School of Public Health. Today’s decision is deeply disappointing because it allows voluntary guidelines to take the place of decisive action in confronting one of the most important public health problems of our time.”
“Reducing antibiotic overuse is essential for making sure antibiotics will keep working for years to come – to treat our sick children, families, and animals,” said Steven Roach, Food Animal Concerns Trust (FACT)’s director of Public Health. “We are very disappointed that the court has not ordered the FDA to stop allowing the overuse of antibiotics on farms. The FDA needs to take long overdue and desperately needed binding action to protect public health.”
The ruling is available here: http://docs.nrdc.org/health/hea_14072401.asp
Today, 80 percent of all the antibiotics sold in the United States are used in livestock production - not humans. Since FDA first recognized the risks of giving low doses of antibiotics in animal feed day after day, nearly four decades ago, the science on the risks of such use has only gotten stronger.
Leading health groups, medical doctors and other scientists from the American Academy of Pediatrics to Infectious Disease Society of America have sounded the alarm, stating that “overuse and misuse of important antibiotics in food animals must end, in order to protect human health.” These groups and others, including the Centers for Disease Control and the World Health Organization, warn that the indiscriminate overuse and misuse of antibiotics in animals that don’t need them can create unstoppable drug-resistant “superbugs” capable of infecting humans. Antibiotic resistance in humans has indeed reached a crisis point, threatening the viability of many life-saving drugs.
A recent U.S. Centers for Disease Control and Prevention (CDC) Antibiotic Resistance Threats report estimated that at least 23,000 Americans die each year from drug resistant infections. Both human and animal uses of antibiotics contribute to the problem. CDC has confirmed the link between antibiotic use on industrial farms and the rise of antibiotic resistance, saying that there is “strong scientific evidence of a link between antibiotic use in food animals and antibiotic resistance in humans,” and warns of “potentially catastrophic consequences” if resistance is not slowed.
In 1977, FDA itself concluded that feeding animals low doses of certain antibiotics used in human medicine, namely, penicillin and tetracyclines, could promote antibiotic-resistant bacteria capable of infecting people, and posed a risk to human health. Despite this, FDA has failed to take meaningful action to curb the misuse of antibiotics on animals that are not sick for over 35 years.
For additional information on this lawsuit and antibiotics in animal feed, see these related links:
- Superbug Suit: Court Slams FDA on Antibiotics in Animal Feed…Again
- Court Orders FDA to Address Antibiotic Overuse in Livestock and Protect Effectiveness of Medicine for Humans
- The FDA appealed the federal court decision last March, and has since trotted out a series of excuses, diversions and evasions. See blogs by Avinash Kar for more:
- FDA announces finalization of voluntary guidance on antibiotic misuse in livestock industry (12/11/13)
- FDA green washing antibiotic reductions (8/26/13)
- An update on NRDC court wins on antibiotic use in livestock: FDA appeals the decisions (10/12/12)
- FDA's Guidance on Antibiotic Use in Livestock: Not What the Doctor Ordered (1/5/12)
- This Holiday, FDA Ignores Public Health and Wishes for Miracles to Solve Antibiotic Resistance (12/22/11)
- Antibiotic resistance rising, but FDA can't resist letting industry have things its way (11/9/11)