All right. Let me get this out of my system. Woo hoo! Try it yourself. Because I have some news we can all celebrate. We just had a great victory in court yesterday that will help protect the health of all Americans.
As far back as the 1970’s, the FDA recognized that the unnecessary use of vast quantities of antibiotics on healthy livestock is contributing to a rise in the prevalence of antibiotic resistant bacteria that compromises the effectiveness of life-saving antibiotics for humans. Antibiotic resistance can lead to longer illnesses, the use of antibiotics with greater side effects, and even death when treatments fail.
Almost seventy percent of all antibiotics sold in the US are used on healthy livestock, to promote faster weight gain and compensate for unsanitary, crowded conditions. Yet, in the face of the rising public health threat of antibiotic resistance, the FDA has largely failed to act.
A huge chunk of the antibiotics used in livestock is comprised of penicillin and tetracyclines, the antibiotics affected by yesterday’s ruling by Judge Katz. All penicillins and tetracyclines together constitute nearly 50% of antibiotic use in livestock. The FDA formally recognized in 1977 that the use of penicillin and most tetracyclines is not shown to be safe and may pose a risk to human health and proposed to withdraw approval for the uses of those antibiotics in animal feed. Penicillin and tetracyclines are important human medicines and their use in livestock may also create resistance to other important human medicines. However, FDA caved to industry pressure and proceeded to do nothing to regulate the use of penicillin and tetracyclines in livestock feed for the next 35 years. NRDC and our partners brought a lawsuit last May to force the FDA to act.
Judge Katz ruled yesterday that once FDA made the finding that penicillin and tetracyclines are not shown to be safe, it was obligated to initiate proceedings to withdraw approval for their use in animal feed unless drug manufacturers prove in a hearing that such use is safe. The FDA’s attempt, around the holidays last year, to get around the law by withdrawing the notices that contained its 1977 findings and by pointing to a set of recommendations for industry on how to reduce antibiotic use was to no avail. The judge’s opinion makes it clear that FDA’s voluntary approach—letting the industry police itself—does not satisfy its legal obligations. FDA must schedule hearings to let drug manufacturers make their case, and if the drug manufacturers cannot prove that the use of antibiotics in animal feed is safe, FDA must withdraw approval for those drug uses.
As the court noted, the science has only gotten stronger on the dangers of allowing the continued use of antibiotics on healthy livestock. Major public health and medical institutions, including the American Medical Association, the American Pediatric Association, the Infectious Diseases Society of America, the Institute of Medicine of the National Academy of Sciences, and the World Health Organization have recognized that antibiotic use in livestock is a significant driver of antibiotic resistance. The European Union has banned the use of antibiotics as growth promoters across its member states since 2006 and is taking further steps to reduce antibiotic use in livestock.
Yesterday’s ruling represents a huge public health victory and one of the most important advancements in the fight against antibiotic resistance in the last 35 years. But the fight is far from over: further court proceedings will likely be required to establish a timeline for FDA to act, and FDA could appeal the decision which could delay action for months or even years.
We are still litigating FDA’s denial of citizen petitions to initiate withdrawal proceedings for other classes of antibiotics important for human medicine. The next stage of court proceedings on this issue will be completed by April 16.
FDA should move forward expeditiously to act on the judge’s opinion and should also act swiftly to curtail the widespread use of other important antibiotics in livestock. It’s well past time for it to stop protecting powerful interests and start protecting the health of the American public.
If FDA doesn’t act to protect public health, we will continue our fight to force FDA to act, if necessary in court.
Photo: Henrik Jonsson/istock