FDA gets full buy-in for phaseout of antimicrobials

The FDA last year slammed drug companies for marketing antibiotics to production operators and farmers that weren't medically viable for their animals, but had more of a quick-fix function: getting them fat. Urged by the regulator, all of the animal health companies affected have voluntarily engaged with the FDA to help remove 283 of the products in question.

The FDA announced with its progress report on June 30 that so far, 31 of the antimicrobials have been withdrawn from the market completely. Twenty-six drug companies, including animal health heavyweights Zoetis ($ZTS), Bayer and Boehringer Ingelheim, are cooperating with the agency in phasing out their products. The agency is now 6 months into a three-year transition period for its actions. The step was taken after years of evidence that overuse of antibiotics in animals can lead to a bacteria resistance and the rise of infections such as MRSA.

There has also been two published label changes, one to withdraw a production claim and one to change a product's marketing status from over-the-counter to available by prescription only. An additional drug label is also pending to change it from over-the-counter to prescription status.

"We see these progress reports as a way to evaluate the impact of our measures on how medically important antimicrobials are used in food producing animals, but we also know there's more work to do," wrote David G. White, of the FDA's Office of Foods and Veterinary Medicine, in a statement.

The FDA is moving to not only fight misleading marketing, but ensure that there's veterinary oversight when dispensing animal drugs. A Department of Agriculture survey says that just shy of half of the country's dairy farmers give their livestock antibiotics without a vet's prescription.

This month has seen heavy criticism from health advocates slamming the use of pumped-up feed to make animals fatter. Novartis ($NVS) came under fire for its Denegard earlier this month, when despite the FDA having made it clear in its animal health rules that antibiotics cannot be medically unnecessary, health advocates said it barely even bothered to advertise the swine antibiotic as medically viable. The Swiss drug company instead highlighted weight gain in animals--a purpose not approved by the FDA.

The American Medical Association (AMA), the nation's largest physician group, last week made public a new and more stringent policy calling for strong federal action to ban antibiotic use in food animals for growth promotion purposes. Its Resolution 513, which was adopted by the House of Delegates earlier this month at AMA's annual meeting, calls for the improved collection of data on how and where animal antibiotics are being used.

- here's the FDA progress report
- and here's an FDA blog post
- read the AMA's stance (PDF)

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