Tomorrow morning, the US Food and Drug Administration will consider whether to accept reauthorization of legislation that allows us to know a few details about how many antibiotics are sold each year for agricultural use.
The agency probably will accept the reauthorization, and you would think that would be a good thing. But the untold story of the legislation — known as ADUFA for the Animal Drug User Fee Act — is that the FDA is forgoing opportunities to compel companies to disclose data that it would be in the public’s interest to know.
Quick back-story: ADUFA originally passed in 2003; its genesis was complaints by the veterinary-pharmaceutical industry that approvals of new drugs were taking too long. The legislation created a “user fee,” charged to the companies, which the FDA used to increase the amount of staff it had available to scrutinize drug approvals and get them passed. (If that sounds like regulated companies paying the salaries of their regulators, yes, that’s effectively what it is.) ADUFA went into effect for the first time that year, and was effective for 5 years. When it came up for re-authorization for an additional 5 years, via the Animal Drug User Fee Amendments of 2008 or “ADUFA II,” public health and consumer advocacy groups pressed the FDA to leverage the benefit being done the manufacturers in order to create some public good. As a result, manufacturers for the first time were asked to publicly, annually report sales of veterinary drugs.
It is because of this additional requirement in ADUFA II that we learned, in 2010, that livestock raised in the United States received 28.8 million pounds of antibiotics per year in 2009, and 29.2 million pounds in 2010. And that’s all we know: Though 2012 is about to end, the 2011 numbers have still not been released. (Here’s the FDA page where the ADUFA reports are posted.)
To be clear: Those numbers are all we know. Below are screenshots of the data from the two ADUFA reports that have been released. (Yes, I know: I suck at Photoshop.) These single tables, which I snipped from the reports, contain all of the data released each year. As you can see, in each year, the FDA released only summed amounts, in kilograms, of all the drugs sold, by all the companies, for all livestock species, across all agricultural uses: growth promoters, prevention, and treatment.
Note: The veterinary pharma companies are not getting together, adding up their sales by drug class for the entire year, and delivering the totals to the FDA. The companies report to the agency individually; they report their data by month, not year; and they report how the drugs are administered, in feed, in water, or by injection.
The FDA receives all this data but is not releasing it, presumably for reasons having to do with its initial ADUFA negotiations with agriculture. We know the agency gets this data because, in 2010, under pressure from Rep. Louise Slaughter (D-NY), the FDA surrendered a further analysis of the first round of ADUFA data from 2009. In its letter to her, the agency broke down the 2009 total of 13.07 million kilograms by route of administration: 9.7 million kg in feed, 2.06 million kg in water, and 422,818 kg by injection to individual animals. The FDA never performed that kind of analysis again.
The current ADUFA II expires in 2013, and the hearing tomorrow addresses ADUFA III, which will govern FDA reporting on ag antibiotics for the next 5 years. By statute, the FDA meets with the industry to hear their recommendations for reauthorization, and also holds public meetings and accepts comment from public health and consumer advocacy groups regarding what they would like to see improved when ADUFA is reauthorized. This year, according to its own web page, the FDA met with industry representatives eight times. It held one public meeting for non-industry representatives in late 2011, and is having this one tomorrow.
At that 2011 meeting, and in the public comment period that the FDA opened in advance of the ADUFA reauthorization, numerous health groups urged the agency to increase both what it asks from industry and what it discloses to the public. Here, for instance, are comments that were filed by the Pew Health Group and the multi-group coalition Keep Antibiotics Working.
“And all of that was pretty much ignored,” says Steve Roach, the public health program director at the Food Animal Concerns Trust and a member of Keep Antibiotics Working.
In their comments, the public health and consumer advocacy groups asked first for the FDA to report out the entirety of the data that it has been receiving, but holding back, since at least 2008 (Edit: This originally said “for 10 years now,” but knowledgeable readers have pointed out that while the FDA may have collected this data from the start, they were only required to do so since ADUFA II), and also to request additional information. Here are the things they asked for:
- Sales and distribution data by dosage form and route of administration — in feed or water or by injection — for every year past, and going forward
- Sales and distribution by indication — that is, for growth promotion; herd disease prevention; or treatment of actual illness (which would help illuminate how many drugs are being given routinely — something that is discouraged in human medicine)
- Sales data from manufacturers of medicated feeds (which would also help illuminate the percentage of antimicrobials that are being given routinely to animals regardless of their health status)
- Sales and distribution data by livestock species
- Sales and distribution data by month, not year
- Information on which drugs being sold for animal use are functionally identical to ones that are considered critically important in human medicine
- Information on what percentage of antimicrobials are being sold over the counter, or by prescription or veterinary feed directive (which would indicate whether the FDA’s plan for moving agriculture toward veterinarian approval of antibiotic use is working).
Here are how many of those things the FDA has agreed to do: None — at least according to the “Proposed ADUFA III Recommendations” listed in the Federal Register notice for tomorrow’s meeting. The recommendations do include a number of things that the agency agrees to change on behalf of veterinary-antibiotic manufacturers, such as agreeing to shorter review times for drug applications, and other “enhancements” of its performance. But there is no sign it has responded to any of the requests made by organizations concerned about the off-farm, downstream, human health effects which occur when those antibiotics are used.
Almost exactly a year ago, the FDA withdrew its decades-on-the-books attempt to exert regulatory control over agricultural antibiotic use, saying that it would instead pursue “voluntary” approaches to getting agriculture to reduce its vast use of antibiotics. (An approach that the FDA’s own staff worried, in internal memos, might not work.) Since then, many people in consumer advocacy and public health have expressed skepticism that agriculture would respond to a voluntary approach. But it’s hard to see how agriculture can even attempt to respond if the FDA doesn’t ask. And looking at the mismatch between what public health has asked for with ADUFA, and what the FDA has put forward as being willing to do, there’s not much evidence it is asking.