March 27th, 2012
FDA “Loses” Court Case on Antibiotics in Livestock Feed
On the evening of March 22, 2012 a federal court ordered the FDA to do more on antibiotic use in livestock to control its use in the hopes of slowing the spread of antibiotic resistance http://www.infozine.com/news/infozine/51254.html. I wonder if there were not those at FDA celebrating this court loss.
Let’s go back a little while. In the mid-1970’s FDA expressed concern about the use of low levels of antibiotics in livestock to increase the size of those animals. This is consistent with my expectations of FDA. Looking at the position consistently taken by FDA in the pharma industry we have to conclude that development of antibiotic resistance is a major issue to the Agency. A brief history of the issue has been prepared by Maryn McKenna and can be found here. The salient message from Ms. McKenna’s blog is that there is clear evidence that the use of antibiotics in livestock feed is a practice that directly leads to an increase in antibiotic resistance and FDA (staunchly opposed to practices leading to the development of antibiotic resistance – author’s note) does nothing of significance in this area for years. Then, right before Christmas of 2011 the Agency issued an order prohibiting certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys. An order which was to become effective April 5, 2012. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm285704.htm
Curious. Cephalosporin is not really widely used in livestock feed, especially compared to other antibiotics such as tetracycline. Also, this order did not even halt all use, just some. In addition, this order completely ignored the far more prevalent use of drugs which have led to drug resistance in the environment (see the McKenna blog entry above). Finally, the notice was released just before the Christmas break (as if hoping it would be missed in the distractions of the holidays). It is almost as if FDA was trying to spark a protest.
Now we come to last Friday where the FDA “lost” the court case. The ruling was in conclusion of a lawsuit filed by the Natural Resources Defense Council, Center for Science in the Public Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned Scientists (UCS) last year. Infozine reports “The ruling compels FDA to take action on its own safety findings by withdrawing approval for most non-therapeutic uses of penicillin and tetracyclines in animal feed, unless the industry can prove in public hearings that those drug uses are safe.” In other words, FDA is ordered to do what it has publically stated is a good idea but has not been able to actually accomplish since 1977.
I know several mid- and upper-level individuals at FDA and without exception these scientists are ethical, honest people sincerely concerned with the public health. In fact, the only disagreement I may have with them is an occasional difference in opinion in how much control over some processes is necessary (they, predictably, are occasionally interested in far more control than I would consider warranted or economically feasible). I can only infer that the organization supporting these individuals reflects their values.
So why the contradiction between public statements about antibiotic use in feed, and actual action? There are perhaps two likely explanations. The first is that FDA is a cynical, evil organization in the pay of big business who is making public statements to appease the masses while participating in a cabal to support profits. The second is that FDA is trying to do its work, but is being restricted in some cases by external pressure. Based on my experience, I think the second explanation is far more likely to be correct.
Please remember, I have no inside information on this – I am just reading blogs and news articles like everyone else. However, I stand by my suspicion that there are people at FDA who are celebrating Friday’s “loss.”
Addendum added April 12, 2012:
FDA issued a press release yesterday on three steps it is taking “…to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.”
- A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
- A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
- A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.”
Here’s the thing – I personally know of draft guidance documents that have taken close to a decade to release due to the intense interdepartmental discussions that are commonplace at FDA. They got three out in three weeks? I stand by my original suspicion that the “loss” of this court case was not entirely unwelcomed by FDA.