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Ending FDA Paralysis on Antibiotics With Two Court Victories and a Push for Transparency

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Twice within the past three months, history was made when a federal court ordered the U.S. Food and Drug Administration (FDA) to take action on the health threat posed by antibiotic misuse in animal feed.

This one-two punch, which was sparked by an NRDC lawsuit, marks the first time FDA has been ordered to act on the widespread overuse of all medically important antibiotics in animal feed and paves the way for ending the livestock industry's abuse of these important medicines -- abuse that puts their effectiveness at risk.

NRDC has just filed a Freedom of Information Act lawsuit against the FDA for failing to timely disclose public documents that may reveal the extent of the danger posed by antibiotic misuse in farm animals. The public has a right to know what FDA knows about the health risks presented by this drug use. Since FDA hasn't turned over these records in response to our request, NRDC is once again taking the agency to court.

Scientists, health care organizations, and government agencies have warned for years that the widespread use of antibiotics to hasten animal growth and compensate for unsanitary and over-crowded feedlots creates a breeding ground for antibiotic resistant bacteria, so-called "superbugs," which threaten to sideline some of our most important drugs for treating infections in people.

Roughly 80 percent of antibiotics used in America are given to pigs, beef cattle, chickens, turkeys, and other farm animals, mostly to promote growth and compensate for the cramped, dirty conditions of factory farms. This overuse of antibiotics (along with overuse by humans) contributes to making bacteria resistant to these life-saving medicines.

Those bacteria don't stay on the farm. For example, an antibiotic-resistant strain of Salmonella bacteria was responsible for illnesses last year that sickened 78 people, hospitalized 22 and killed one, forcing the recall of 36 million pounds of turkey. Drug-resistant infections caused by these and other antibiotic-resistant bacteria have been estimated to cost Americans up to $26 billion every year. The federal Centers for Disease Control reported that Methicillin-resistant Staphylococcus aureus (MRSA), one of many kinds of superbugs, caused nearly 95,000 infections and more than 18,000 deaths in 2005 -- causing more fatalities than HIV/AIDS in that year.

Leading health organizations -- including the Centers for Disease Control and Prevention, American Academy of Pediatrics, American Medical Association, Infectious Diseases Society of America, Institute of Medicine of the National Academy of Sciences, and the World Health Organization -- agree that the routine use of low-doses of antibiotics in livestock is a significant contributor to the rapid proliferation of antibiotic resistant bacteria in both animals and humans.

Since the mid-1970s, the FDA's own scientists have recognized the threat. In 1977, the agency started proceedings to ban the non-therapeutic use in livestock of two important classes of antibiotics, penicillin and tetracyclines, but never followed through. The agency has done little to limit the practice since then -- despite acknowledging the risks.

The FDA's preferred "solution" is a loophole-riddled "voluntary guidance." FDA claims the livestock industry can police itself with these optional guidelines. The thing is, they have already been operating this way since 1977. The Administration's preferred path is a virtual guarantee of the status quo.

Revealingly, in court documents, the agency said that if it started limiting antibiotics in animal feed, the livestock and pharmaceutical industries would protest so strongly it would consume too much of the agency's time and resources, suggesting the agency is acting on its fear of the pharmaceutical and agricultural industries rather than doing what is best for human health. Instead, FDA claimed voluntary guidelines for industry to follow would be more effective and faster. As the court pointed out, that seems contradictory -- if the industry would comply voluntarily with guidelines, why would it fight regulatory proceedings? -- unless, of course, the guidelines are weaker.

In response to FDA's claim that the voluntary approach would be less time consuming, the court said: "The position that instituting withdrawal proceedings -- what the statute mandates -- is too time-consuming is both ironic and arbitrary. Had the Agency addressed the Petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now."

With this spring's federal court orders, there is no more excuse for delay.

It's time for FDA to comply with the court orders and establish mandatory restrictions on drug misuse.

It's time for FDA to act like the public health agency it is and reveal documents examining this health threat.

And above all, it's time for FDA to step up and ensure that antibiotics are preserved for when we need them most: to heal sick people.

If you agree, please join us in the fight and let our leaders know you want FDA to get to work today.

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