Future generations will wonder why the Food and Drug Administration (FDA) didn’t take action as our life-saving antibiotics slipped away.
That’s what’s happening now. The medicines that have always worked to treat an infected cut, a urinary tract infection, or pneumonia (and many other diseases), or to enable a surgery or chemotherapy, are beginning to fail. In May, for example, feared superbugs were found for the first time in the US, isolated from both a person and a pig, carrying shareable resistance to Colistin, a last-resort drug that doctors only turn to when nearly every other drug has failed. The Director of the Centers for Disease Control and Prevention (CDC) summed it up this way: “It basically shows us that the end of the road isn’t very far away for antibiotics—that we may be in a situation where we have patients in our intensive care units, or patients getting urinary-tract infections for which we do not have antibiotics.”
Antibiotic resistance results from the overuse of antibiotics, both in human medicine and in livestock production. Simply put, when the drugs are used again and again, some bacteria become resistant, multiply and spread, contributing to a growing number of resistant bacteria in our communities and environment. Livestock use accounts for a whopping 70% of total antibiotic sales in the US. Chicken, turkey, pork and beef producers use antibiotics to make animals grow faster and help them survive crowded, stressful, unsanitary living conditions that are typical in industrial animal production. But using antibiotics to cut costs in meat production means humans will pay dearly as the human medicines fail to work.
Today, NRDC and several other groups formally petitioned FDA to curb overuse of livestock antibiotics. FDA holds the job of approving and regulating livestock drugs. They are required by law to disapprove or cancel drugs found to pose a threat to human health. The petition argues that FDA must curb uses of these drugs, because, as currently used, they result in the proliferation of antibiotic resistant bacteria.
This is not the first time the agency has been confronted with this evidence. FDA’s own scientists raised the same concerns in 1977. Documents obtained by NRDC under a Freedom of Information Act Request show that an extensive review by FDA’s own scientists between 2000 and 2010 similarly found that nearly two-thirds of the antibiotics reviewed were found to pose a high risk for spreading drug resistant bacteria that could harm humans.
Citing the agency’s own 1977 findings of a health risk, NRDC sued FDA in 2011 in federal court and won. Instead of using the ruling to justify new regulations (which would likely be unpopular with the livestock and pharmaceutical industry), FDA appealed the case and won, persuading two of the three appeals court justices that it would get the job done quicker via an alternative, voluntary scheme in collaboration with the pharmaceutical industry.
Five years later, it’s clear that the scheme is failing. Antibiotic use has actually increased in total, and also on per-animal basis. More importantly, FDA’s plan focuses primarily on eliminating the use of antibiotics for growth promotion (it turns out these drugs sometimes make the animals grow a bit faster), but FDA and the animal drug industry both agree that this comprises only 10% to 15% of use. Furthermore, FDA would allow the same growth promotion antibiotics to be used as long as the companies don’t say their purpose is for growth promotion. So the same uses could continue under a different label. We explain this here. At the end of the day, FDA’s scheme mostly ignores 85-90% of the antibiotic use and further loopholes mean that even eliminating the smaller fraction is also uncertain. Yesterday’s announcement from FDA—that it may recommend to drug manufacturers that they put some limits on the amount of time a drug may be used so that they are no longer open-ended—doesn’t change the equation. Even if it comes to be, it would remain just a recommendation, and it would continue to condone disease prevention use, potentially for very long defined periods of time.
Given the accelerating proliferation of drug resistant bacteria, what may seem like a theoretical, distant problem to many will quickly become personal and real for millions of Americans. The problem is that the longer the agency waits to take real actions, the fewer drugs we’ll have left to save, if any.