Source NY Times
The Obama administration must warn drug makers that the government may soon ban agricultural uses of some popular antibiotics that many scientists say encourage the proliferation of dangerous infections and imperil public health, a federal magistrate judge ruled on Thursday.
The order, issued by Judge Theodore H. Katz of the Southern District of New York, effectively restarts a process that the Food and Drug Administration began 35 years ago, but never completed, intended to prevent penicillin and tetracycline, widely used antibiotics, from losing their effectiveness in humans because of their bulk use in animal feed to promote growth in chickens, pigs and cattle.
The order comes two months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia, strep throat and skin and urinary tract infections.
Siobhan DeLancey, an F.D.A. spokeswoman, would not say whether the government planned to appeal. “We are studying the opinion and considering appropriate next steps,” she said.
In a separate move, the F.D.A. is expected to issue draft rules within days that ask drug makers to voluntarily end the use of antibiotics in animals without the oversight of a veterinarian.
But neither the judge’s order nor the F.D.A.’s expected rule changes are likely to fundamentally alter the large-scale agricultural uses of antibiotics because farmers and ranchers now say the drugs are being used to prevent animal diseases, not to promote growth. The F.D.A. has so far refused to propose restrictions on antibiotic uses to prevent disease even when the drugs are delivered in feed or water, and Judge Katz’s order does not extend to disease prevention uses.
Gwen Venable, a spokeswoman for the U.S. Poultry and Egg Association, said that poultry producers “judiciously use antibiotics to maintain the health of their flocks.”
“Our association has not had an opportunity to review the judge’s order, so we cannot comment on the impact of the specific decision at this time,” she said.
Environmentalists and health advocates cheered Judge Katz’s ruling, as they have largely cheered the F.D.A.’s incremental efforts to begin restricting some of the less discriminating antibiotic agricultural uses because they welcome any improvement in the decades-old issue.
“The rise of superbugs that we see now was predicted by F.D.A. in the ’70s,” said Jen Sorenson, a lawyer for the Natural Resources Defense Council.
But agricultural trade groups were more critical. Ron Phillips, vice president of public affairs for the Animal Health Institute, an association representing companies that make animal medicine, said that the judge’s order could slow efforts to reduce agricultural uses of antibiotics by diverting resources from the agency’s collaborative efforts with industry.
Antibiotics were the wonder drugs of the 20th century, and their initial uses in humans and animals were indiscriminate, experts say. Farmers were impressed by the effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs, and added the drugs to feed and water, with no prescriptions or sign of sickness in the animals.
By the 1970s, public health officials had become worried that overuse was leading to the development of killer infections resistant to treatment. In 1977, the F.D.A. announced that it would begin banning some agricultural uses. But the House and Senate appropriations committees passed resolutions against the ban, and the agency retreated.
“In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence the F.D.A. has changed its position that such uses are not shown to be safe,” Judge Katz wrote in his order.
Eighty percent of antibiotics bought in the United States are used in animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity, killing thousands.
Environmental and health groups petitioned the F.D.A. in 1999 and 2005 to restart the process to ban the drugs for promoting animal growth. The Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen and the Union of Concerned Scientists filed suit against the F.D.A.
On Thursday, Judge Katz ruled that these groups had won their case without need for a trial.
Judge Katz ordered the F.D.A. to alert drug manufacturers that it intended to prohibit the use of penicillin and tetracycline to promote growth in animals. The manufacturers can request a hearing to present evidence that these uses are safe. If the companies have such evidence, the drugs can continue to be used for growth promotion, the judge wrote.