The FDA Gets Another Pass on Dealing With Antibiotic Use in Livestock
Thanks to an appeals court ruling, the agency doesn’t have to act on its own science.
The “next pandemic.” That’s what Centers for Disease Control and Prevention director Tom Frieden said antibiotic resistance could bring about in an appearance at the National Press Club on Tuesday.
It’s the latest in a string of apocalyptic remarks from CDC folks about the risk presented by the superbugs that are costing an estimated $20 billion in heath care per year. We are, also per the CDC, already living in the post-antibiotic era.
The CDC’s sister agency, the Food and Drug Administration, has for decades said that the subtherapeutic use of antibiotics in livestock animals—which it’s responsible for regulating—is part of that risk. The drugs are mixed into animal feed at low doses to help promote weight gain, allowing feedlots to produce more meat for less money. In 2011, thirty million pounds of antibiotics were sold to the livestock industry. Despite this commonplace usage, drug companies “failed to resolve the basic safety questions that underlie the subtherapeutic use of [antibiotics] in animals,” according to the FDA.
That’s from a notice of opportunity for hearing issued in 1977—a hearing that, like another notice issued in ’77, was never held. Yesterday, 37 years later, the U.S. Second Circuit Court of Appeals ruled that the agency does not have to consider banning the use of the antibiotics despite the risks it has acknowledged and studied for decades.
“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,” Judge Robert Katzmann wrote in his dissent. “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.”
The 2–1 decision overturned a lower court that ruled in favor of the Natural Resource Defense Council, which sued the FDA on behalf of a coalition of environmental and public health groups in 2011. The ruling says the FDA “could essentially ignore their own conclusions and move forward with this voluntary strategy,” announced last December, says NRDC attorney Avinash Kar.
Despite the outcome of the ruling, the majority opinion opens with pages and pages of historical context, citing numerous documents from the FDA itself, which makes a compelling case for ending the practice. The majority opinion, for example, cites a 1972 report from an FDA task force that found subtherapeutic antibiotic use breeds resistance bacteria, that the resistant bugs can jump from livestock animals to humans, and that the amount of resistant bacteria had both increased and been found in meat and meat products.
Although the FDA has said time and again that the practice is dangerous, it’s just never really gotten around to doing much about it.
The majority’s argument against the subtherapeutic use of antibiotics in livestock animals is part of a ruling against the NRDC because the case hinged not on the efficacy or riskiness of the practice, but on the language of the Food, Drug, and Cosmetic Act. As the government—and the appeals court—reads the act, the FDA is required to revoke approval for a drug “only after a hearing is held and a finding is made.” In 1977, the agency only issued two notices of opportunity for hearings—hearings that never occurred. The notices were withdrawn in 2011, and two long-ignored public petitions calling on the agency to act were denied, after the NRDC filed suit.
Which leaves the voluntary regulations, which have “a bunch of shortcomings,” according to the NRDC’s Kar. “One of the first things about the voluntary guidelines—and what is an accepted part of the voluntary guidelines—is that there is a risk here.” In other words, the FDA is continuing its long, harmful tradition of saying that antibiotic use is a problem but that it’s not going to do anything significant to address the situation.
“The good thing here,” Kar adds, “is that there’s a growing recognition of antibiotic resistance and what that could mean for people’s health—and animal agriculture’s role in that resistance.”
If the CDC continues making its headline-grabbing end-times comments about resistance, maybe the FDA will, despite the leeway this ruling gives it, finally end its decades of inaction.