The U.S. Food and Drug Administration must act on scientific knowledge that the overuse of antibiotics in food animals has contributed to the rise of antibiotic-resistant infections in humans.
This ruling made by a federal court on Thursday night now compels the FDA to withdraw approvals for most non-therapeutic uses of penicillin and tetracyclines in livestock, unless drugmakers are able to show that they are safe.
Public health experts don't foresee such evidence surfacing. "As the judge noted, and as we've maintained, the science has only gotten stronger in the intervening decades," Avinash Kar, Natural Resources Defense Council health attorney, told The Huffington Post.
The decision comes in response to a lawsuit filed last May by the NRDC concerning findings made by the FDA back in 1977. Feeding livestock low doses of penicillin and most tetracyclines, the agency had concluded, might pose a risk to human health. But the FDA never acted on or retracted those findings. Now, according to the court, those findings obligate the agency to act.
Misuse and overuse of antibiotics can speed up the development of resistance: Bacteria that can withstand the drugs will survive and reproduce, while their antibiotic-susceptible counterparts will evolve out of the picture. The result is decreased effectiveness of antibiotics in human medicine and an increasing threat of deadly methicillin-resistant staphylococcus aureus (MRSA) and other difficult-to-treat infections.
"Things as common as strep throat or a child's scratched knee could once again kill," World Health Organization Director-General Dr. Margaret Chan recently told a group of infectious disease experts in Copenhagen.
Some of this misuse and overuse occurs in human medicine. But as HuffPost previously reported, cattle, swine, chickens and other livestock receive an estimated 80 percent of the nation's antibiotics. Whether used to treat our future food, prevent the spread of disease in cramped conditions or simply to promote growth, animal antibiotics are thought to affect human health via multiple pathways: direct or indirect contact with food, water, air or anywhere manure goes.
Public health experts are hopeful that the court's decision will lead to significant protections for public health. Rather than relying on the FDA to show the practice is harmful, the ruling "lets them give the benefit of the doubt to people and the environment," said Gail Hansen, senior officer with the Pew Campaign on Human Health and Industrial Farming.
Still, even if hurdles such as an appeal don't surface and the drug approvals are withdrawn, it's difficult to say if and when superbugs will diminish, according to Hansen. "We know that we can have persistence of resistance. How long that will last, or if it's even if reversible, isn't clear," she said. "We are sort of our own experiment."
A U.S. study, published last August, found going organic and stopping antibiotics use resulted in quick and significant reductions in antibiotic resistance.
The Animal Health Institute, which represents pharmaceutical companies, said in a statement that the move could actually "delay the process of eliminating the subtherapeutic (growth promotion) use of medically important antibiotics…. FDA has said the collaborative, stakeholder process is a more efficient way of achieving these goals than the process being forced by the court. It is unfortunate that time and resources will now be diverted to responding to the court decision."
The FDA issued draft voluntary guidance in 2010, which offers suggestions to industry rather than imposing a ban. The federal court said that this action was not sufficient.
In its original lawsuit, the NRDC also addressed citizen petitions filed in 1999 and 2005 that sought to eliminate the use of a broader range of antibiotics in livestock. When the FDA rejected the petitions last year, the agency said they were continuing instead with their non-binding guidance strategy. Litigation on this piece of the lawsuit is ongoing, noted Kar.
"It will now be very difficult, if not impossible, for the agency to continue to take that position on other drugs," said Ellen Silbergeld, a professor at Johns Hopkins School of Public Health. "This really should be seen as the beginning of the end."
Kar cautiously agreed. "This is a first and important step," he said. "But the fight is not completely won."
CORRECTION: An earlier version of this article stated that the FDA had rejected the citizen petitions due to insufficient evidence.