FDA Reverses Cephalosporin Ban
RENEE MONTAGNE, host:
This is Morning Edition from NPR News. Good morning, I'm Renee Montagne. One of the most important drugs for treating infectious diseases in people is an antibiotic that the Food and Drug Administration was planning to limit in animals. That's because, the more the drug is used, the sooner it loses its potency. But in a little-noticed move, the agency changed course. It has decided not to set limits on this particular drug's use, at least for now. NPR's Joanne Silberner reports.
JOANNE SILBERNER: Let's start with antibiotic resistance. It can happen when a whole slew of bacteria are exposed to an antibiotic. Some of them are able to resist the drug, and those resistant bacteria thrive and multiply.
Last July, the FDA announced plans to limit the use of the antibiotic Cephalosporin in animals, as a way of keeping superbacteria from spreading and infecting people. At the same time, the agency asked industry academic researchers and the general public for their thoughts on the plan. On November 26th, four days before the limit was to go into effect, the agency canceled it. Steven Vaughn heads the Center for Veterinary Medicine at the FDA.
Mr. STEVEN VAUGHN (Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, FDA): We need to have time now to go back and take a look at that scientific evidence and those substantive comments, to make sure that we're making the most effective decision that we can.
SILBERNER: And that's a good thing, says Gatz Riddell. He's a veterinarian and a spokesperson for the American Association of Bovine Practitioners. He says vets should be able to use Cephalosporin even for illnesses that aren't listed on the drug's label; that's called extra-label or off-label use.
Mr. GATZ RIDDELL (Veterinarian; Spokesperson, American Association of Bovine Practitioners): In our opinion, there is no data available that shows that extra-label use, in and of itself, in the cattle species is a serious threat.
SILBERNER: He says there have been incidents when humans picked up Cephalosporin-resistant bacteria from animals, but those bacteria didn't last long. Not so, says antibiotic researcher Stuart Levy at Tufts University. He says the resistant bacteria just don't fade away.
Professor STUART LEVY (Department of Medicine, Tufts University): If we allow off-label use, there will be no control on how a very valuable antibiotic is used. And my experience would say that it will only be to increasing amounts of resistance. It's not going to go up and down.
SILBERNER: In a letter supporting limits on Cephalosporin, the Centers for Disease Control and Prevention said, curbing Cephalosporin use in animals would be an important public health advancement. Several advocacy groups called the FDA change of mind a holiday gift to the meat industry.
Mr. STEVE ROACH (Keep Antibiotics Working): We just thought this was a betrayal of the public trust.
SILBERNER: Steve Roach of the advocacy group Keep Antibiotics Working says the FDA should have stuck to its original plan.
Mr. ROACH: They started off intending to protect the public health, but when they heard back from the industry, they just backed down immediately, and we think this was wrong.
SILBERNER: The FDA's response is it's not industry pressure that changed the agency's mind.
Mr. VAUGHN: If there had been industry pressure, the ramification would have been the end of the process. But instead, we are moving forward looking at this evidence, deciding on where the science takes us, so that we can make the most effective intervention that we can.
SILBERNER: The FDA's original decision to limit Cephalosporin use came after it considered published and unpublished information, and the recommendation of outside experts. Now the agency will do it all over again, come up with a new recommendation, and put its plan out for public comment once again. Joanne Silberner, NPR News, Washington.
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