Public health advocates are ramping up their effort to reform how antibiotics are used in animal agriculture after two petitions to the U.S. Food and Drug Administration were denied last week. The push coincides with “Get Smart About Antibiotics Week” in the United States, and comes right as the European Union launches a new 5-year strategy to tackle antibiotic resistance.
The strategy announced by the the European Commission, the governing body of the EU, calls for the judicious use of medically important antibiotics by phasing out preventative use of these particularly drugs in food animal production–which is exactly what U.S. advocates would like to see happen on this side of the pond, where 80 percent of all antibiotics sold are given to food animals.
“It’s a shame that after all these years the US is still caught flat-footed,” said Representative Louise Slaughter (D-NY) Thursday, in response to the EU announcement. “We’ve known that this is a problem for quite some time. And we’re totally unprepared to deal with the growing threat of antibiotic resistance, as was confirmed by the GAO, by not even collecting the necessary data. The American public should be outraged.”
In lieu of strong action by the U.S. Food and Drug Administration, Rep. Slaughter, the only microbiologist serving in Congress, has led the effort on Capitol Hill to legislate limits on administering medically important antibiotics to the animals we eat. Slaughter’s bill, the Preservation of Antibiotics for Medical Treatment Act (PAMTA), was originally introduced 2007 and has since been re-introduced.
Though the bill now has 70 cosponsors in the House and 8 signed on in the Senate, it isn’t moving anywhere fast. In the House, it was referred to the Energy and Commerce Committee’s Subcommittee on Health, but the bill doesn’t have a single Republican co-sponsor in a Republican-controlled Congress (though Senator Susan Collins (R-MN) is a co-sponsor in the Senate).
“There is no indication that the committee even plans on holding a hearing,” a spokesperson from Slaughter’s office told Food Safety News. “But obviously we are hopeful that they will begin to take the issue seriously.”
Meanwhile, interest groups keep working to make their case to lawmakers and their staff. This month, there were two briefings on Capitol Hill that discussed antibiotics in agriculture.
On November 3, the Animal Health Institute, which represents the veterinary pharmaceutical industry, held a panel discussion highlighting animal medicines as “an important link in the food safety chain” and critical to “providing a healthier food supply.”
As AHI explains it, though animal medicines are preventing diseases and treating sick animals, “how and when they are administered, continue to be a topic of debate from the farm to Capitol Hill.”
“Unfortunately, there are a lot of misconceptions about the use of antibiotics and other medications in animals raised for food,” said Dennis Cardoza (D-CA), Ranking Member of the Subcommittee on Livestock, Dairy, and Poultry of the House Agriculture Committee, who keynoted the event.
“Many of the current legislative proposals put forth in reaction to these complicated issues only exacerbate the problem,” said Cardoza. “They are championed by people who don’t fully understand agriculture, or don’t understand the role that medicinal treatments can play in overall health in our food supply.”
Cardoza, a conservative Democrat whose district produces more dairy products than any other in the United States, argued that decisions should be based on science. “Prevention is absolutely key,” he said in his remarks. “Get in front of it before you have a crisis.”
But reform advocates argue that the science is overwhelmingly in favor of reducing the subtherapeutic use of certain antibiotics in agriculture.
In a review study published last month, Tufts University School of Medicine researchers found that “the preponderance of evidence argues for stricter regulation of the practice.”
“The United States lags behind its European counterparts in establishing a ban on the use of antibiotics for growth promotion,” said Stuart Levy, a leading expert on antibiotic resistance and professor of molecular biology and microbiology and director of the Center for Adaptation Genetics and Drug Resistance at Tufts University School of Medicine.
“For years it was believed that giving low-dose antibiotics via feed to promote growth in cows, swine, chickens and the use of antibiotics in fish farming had no negative consequences,” said Levy. “Today, there is overwhelming evidence that non-therapeutic use of antibiotics contributes to antibiotic resistance, even if we do not understand all the mechanisms in the genetic transmission chain.”
Last week, Food and Water Watch, Consumers Union, STOP Foodborne Illness, Center for Science in the Public Interest, and the Union for Concerned Scientists teamed up to brief staffers on the issue, specifically linking antibiotic misuse to foodborne illness outbreaks caused by antibiotic-resistant pathogens.
Diana Goodpasture, a victim of the recent multi-drug resistant Salmonella Heidelberg outbreak tied to ground turkey, traveled from Akron, Ohio to share her personal story and urge Congress to limit antibiotic use. Goodpasture was hospitalized for an extended period of time during her illness and still suffers from lingering health complications stemming from her Salmonella infection.
The briefing came just days after FDA denied two key petitions on subtherapeutic antibiotic use.
In its denial letters, the agency acknowledged shared concern and “the need to address concerns related to the role that antimicrobial drug use in food-producing animals plays in the emergence and selection of antimicrobial drug resistant bacteria.” But the agency also cited statutory hurdles — such as a notice to the drug maker and an evidentiary hearing on the matter — as reason to deny the petition.
Instead, FDA is “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.”
David Plunkett, a staff attorney at CSPI, told staff last week at the briefing he believes the agency is “crying for help” on the issue, adding that it makes little sense to agree with the science cited in the petitions and not take action.
“We’ve seen time and time again that FDA acknowledges that this is a public health threat and something needs to be done about it, but not strong action has been taken,” added Justin Tatham, the Washington representative for UCS.
As FDA noted in its rejection letters, the process of withdrawing certain medically important antibiotics from approval would likely be extremely resource intensive.
“The agency’s experience with contested, formal withdrawal proceedings is that the process can consume extensive periods of time and agency resources,” said FDA in the denial letter. The agency cited the withdrawal of diethylstilbestrol (DES) in 1979, which took a full seven years to complete, and the withdrawal of enrofloxacin in poultry, which took almost five years and cost FDA approximately $3.3 million.
DES is a synthetic growth hormone that was used both clinically and in the beef and poultry industry in the 1960s. It was eventually found to cause breast, prostate, and vaginal cancer. Enrofloxacin is an antibiotic that was FDA-approved for subtherapeutic use in poultry until it was found to promote antibiotic resistant strains of Campylobacter.