So, FDA has finally come out with its much talked-up voluntary guidance (read, recommendations) for the pharmaceutical and livestock industries on appropriate antibiotic use and avoiding antibiotic resistance. It has been pending in draft form for over a year and a half and has been long-criticized as a hollow gesture to tackle antibiotic resistance. Despite FDA’s assurances, the reality is that this final guidance: 1) doesn’t do much, 2) pretends to do more, and 3) kicks the can significantly down the road. Here’s why:
It doesn’t do much: It’s voluntary. As I have blogged about before, the guidance is voluntary. It asks drug manufacturers to voluntarily stop selling antibiotics to speed up animal growth. The livestock industry accounts for 80% of their antibiotic sales. Do we really think the pharmaceutical industry is going to voluntarily walk away from such a big chunk of its customer base? I don’t see that happening.
It pretends to do more: It would allow much of the problematic use to continue under a different name. The problem of voluntary action is compounded by the fact that this doesn’t actually stop the problematic uses. Even if the drug manufacturers stopped selling antibiotics to speed up growth, they could continue to sell them for a very similar use: to prevent diseases associated with crowded and stressful conditions on many livestock facilities. Not only is the use very similar in nature—low doses added to the feed of a large number of animals day after day—many of the antibiotics are approved for both kinds of uses.
FDA says in its guidance that “the Agency is concerned . . . that giving antimicrobial drugs to food-producing animals at low levels for long periods of time and in large numbers of animals may contribute to antibiotic resistance.” This is as true for disease prevention uses as it for growth promotion uses.
Effectively, the policy could amount to a change in label, but not in practice. It’s pretending to do more than it really does.
For instance, the United States Government Accountability Office (GAO) reported in 2011 that:
One veterinarian told us that if FDA withdrew an antibiotic’s approval for growth promotion, he could continue to give the antibiotic to the animals under his care at higher doses for prevention of a disease commonly found in this species. The veterinarian stated that there is an incentive to do so because using an animal antibiotic can help the producers he serves use less feed, resulting in cost savings.
It kicks the can down the road: When FDA put out the draft guidance in April 2012, it was conveniently timed to coincide with briefing in the legal case that we and our partners brought against the FDA. The April 2012 draft proposed that FDA would give the voluntary program three years from when the guidance was finalized and then evaluate whether binding regulations were required. That’s not counting how long it will take FDA to go through the regulatory process. It’s now a year and a half later. That clock will only start ticking now. (The fact that the clock has at least started is the only silver lining here, other than the acknowledgement that there is an antibiotic resistance problem, which this guidance claims to address.)
And it’s important to also take note of who seems to have a heads up on all of this. The animal pharmaceutical company trade association, the Animal Health Institute, sent around a press release yesterday announcing a press conference about the guidance. They clearly knew about the finalization of the guidance beforehand. Nobody in the public health community had heard about the timing until that press release came out. What does that say about the priorities embodied in this guidance? Yes, the foxes are guarding the henhouse, and they seem to know where the holes in the fence are.
We hope that FDA means what it says about shifting to binding regulations if this voluntary approach doesn’t work and that it will stick to the timelines it has laid out. But you will forgive me if I don’t express great faith in an agency that has been dragging its feet on this issue of antibiotic use in livestock and antibiotic resistance for the last 35 years.
We will certainly keep pressing the FDA to stick to its timelines. In the meantime, a decision is pending in our case against FDA, which could direct FDA to take meaningful action sooner. We look forward to that ruling and will continue to push for action through every avenue available to us.