Earlier today, the FDA took a moment to pat itself on the back once again, by announcing a show of “strong industry commitment” to the 2013 guidance. What this means is that 25 of the 26 drug companies affected by the voluntary measure have “committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.”
What does that actually mean? Let’s break it down, shall we?
First, there are a number of antibiotics that are currently approved for “production” use, meaning they are given to the animals for no reason other than that they helped in the growth of muscle tissue. The 25 drug companies have asked the FDA to withdraw these approvals.
Thing is, for many of the drugs, this won’t matter. As Avinash Kar of the Natural Resources Defense Council recently told Consumerist, a large number of antibiotics used for production purposes are also approved for preventative medical use in animals.
So for the drugs that currently have both types of approval, this withdrawal request just shifts the farmers’ purported reason for using the medicine from “production” to “disease prevention.”
Second, the drug companies are asking to change the designation of drugs approved for medical use from over-the-counter, meaning farmers could just buy them directly, use as directed by a veterinarian.
Again, there are good intentions here, as the FDA attempts to add a layer of responsibility in the form of a veterinarian.
However, as numerous advocates of stricter antibiotic guidelines have pointed out, there is little to prevent the widespread use of these drugs under the umbrella of disease prevention. Of course, that goes against all the scientific evidence showing that overuse of antibiotics results in the development of drug-resistant pathogens.
Senator Elizabeth Warren from Massachusetts attempted to discuss this point when FDA chief Margaret Hamburg appeared before the Senate Committee on Health, Education, Labor & Pensions earlier this month, but Warren’s time ran out before they could have a proper chat on the issue.
In response to today’s announcement, Keep Antibiotics Working — a coalition of health, consumer, agricultural, environmental, animal welfare, and other advocacy groups — says it is both appreciative of the FDA’s effort to be transparent about the process, and skeptical that this not-exactly-ironclad guidance will have any positive effect on the public health threat caused by antibiotic resistance.
“First, these letters submitted by the drug companies are not binding, so the companies can still stop participating at any time,” says KAW Senior Senior Analyst Steven Roach. “Even more important, FDA has done nothing to limit the continued use of antibiotics for routine disease prevention. In terms of dose, duration, and number of animals the drug is being administered to, this type of use can be identical to growth promotion, which the FDA is asking the companies to phase out.”
Roach says that what’s needed is for the FDA to collect data on which (and how many) animals are receiving which (and what quantity of) these antibiotics, and why these animals are receiving the drugs. So rather than just a sweeping “no more drugs for production” rule that still allows widespread preventative use, consumers would know if the guidelines are actually cutting down massive quantity of antibiotics being provided to farm animals.
And the odds are that the FDA rules, as they currently stand, are only being viewed as a laughable hurdle by both big pharma and big farm. As we pointed out when the initial guidance was released, even though farm animals account for 80% of the antibiotics sold in the U.S., multiple drug companies said they were not concerned about the FDA guidance having any negative effect on their bottom lines, implying that the same number of drugs will be sold regardless of the voluntary measures.
Equally skeptical is NRDC’s Kar, who says “There is still no evidence that the FDA’s voluntary plan will do anything to limit the increase in the antibiotic-resistant bacteria that endanger all of us. Animals will still be fed antibiotics daily even though they aren’t sick. While it’s good to see FDA and corporations coming to the table on this, their solution doesn’t cut it. Fixing the problem means curbing the misuse of these drugs. This plan is likely to lead to label changes, not a reduction in use.”
“Getting the companies to send letters is the easy part,” says Roach. “Actually reducing antibiotic overuse is the real challenge.”
“We don’t add antibiotics to the cereal of kids to prevent diseases in daycare centers, and we shouldn’t be doing this with animals,” adds Kar. “FDA needs to dramatically reduce antibiotic use in animals. Until that happens, the rest is just window dressing.”