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fluoroquinolones: a (slow) success story

In July 2005, the Food and Drug Administration (FDA) finally withdrew its approval for use of fluoroquinolone antibiotics (FQs) in poultry, nearly five years after first proposing to do so. This is the first time the FDA has banned an agricultural antibiotic due to concerns about antibiotic resistance. The Keep Antibiotics Working coalition (KAW) strongly supported the ban since it was first proposed in October 2000. It became effective on September 12, 2005.

Fluoroquinolones – a class of antibiotics that includes Cipro – are highly useful in human medicine. Fluoroquinolones are effective against a wide range of disease-causing bacteria, are easy to use and have few side effects. Fluoroquinolones also are the drug of choice for treating severe cases of bacterial food poisoning in adults, such as that caused by Salmonella or Campylobacter bacteria. Details of the five-year battle to ban fluoroquinolone use in poultry are given below.

Why Fluoroquinolone Use in Poultry was a Problem
In 1995, nearly a decade after U.S. physicians began prescribing fluoroquinolones for humans, the Food and Drug Administration (FDA) approved them for use in poultry as well. FDA approval came despite evidence from Europe that animal use of fluoroquinolones ultimately would boost the number of people infected with bacteria resistant to the medicine. In 1999, 38,000 pounds of fluoroquinolones were used in animals, according to industry estimates.

Poultry producers used fluoroquinolones not to promote faster growth, but to treat outbreaks of respiratory disease in poultry flocks crowded into huge sheds sometimes typically containing hundreds tens of thousands of chickens or turkeys. Yet because fluoroquinolones were given to entire flocks indiscriminately in their drinking water, near-ideal conditions for speeding the development of resistance were created.

This is exactly what has happened in the U.S. in just a few short years. FDA scientists found that fluoroquinolone use in chickens and turkeys sped the development of fluoroquinolone-resistant Campylobacter. People commonly acquire Campylobacter by eating or mishandling contaminated poultry; the FDA estimates that Campylobacter contaminates up to 80 percent of broiler chickens in some supermarkets. Fluoroquinolone-resistant strains of Campylobacter were infecting increasing numbers of people; in fact, in 1999, CDC reported that one in six Campylobacter infections was resistant to fluoroquinolones. A decade ago, such resistance was negligible. (By 2002, resistance to Cipro in Campylobacter in humans had risen to 21 percent.) FDA conclude that the use of fluoroquinolones in poultry "not shown to be safe."

FDA therefore proposed in October 2000 to ban the two approved fluoroquinolone poultry products, on the ground that they were "not shown to be safe." The manufacturer of one of the products, Abbott Laboratories, withdrew its drug from market immediately, even before FDA officially proposed the ban. The other, Bayer Corporation, chose instead to launch a lengthy battle that delayed the ban by nearly five years.

The Campaign Called on Bayer to Act Responsibly
Immediately after FDA announced the proposed ban, KAW called on Bayer Corporation, manufacturer of the poultry fluoroquinolone remaining on the market, to comply voluntarily by removing its product from the market. Bayer instead requested a hearing before an FDA Administrative Law Judge (ALJ), and filed so much paperwork that it took ALJ Daniel J. Davidson until March 2004 to issue his decision. The ALJ upheld the proposed ban and rejected all of Bayer's arguments, criticizing them as "inconsistent" and "not reliable;" he also rejected the testimony of Bayer's key scientific witness (consultant Tony Cox), saying that his credibility was "severely compromised and his testimony cannot be relied on." KAW also composed a rebuttal to Bayer's false claims regarding the FDA proposal. Read a summary of the 68-page decision and KAW's news release.

Bayer then appealed the ALJ decision to the FDA Commissioner. On July 28, 2005, the Commissioner upheld the ALJ's decision, and noted that many of Bayer's contentions were "frivolous or trivial." (See FDA's decision.) This action is the first time that FDA has ever withdrawn an agricultural antibiotic from the market because of concerns about antibiotic resistance affecting human health (see KAW's press release).

On August 26, Bayer petitioned FDA to stay the ban's scheduled September 12 effective date so that Bayer could seek judicial review of the decision (see KAW's press release). The FDA Commissioner denied the request, noting that that Bayer failed to meet any of the four criteria for a stay. Bayer subsequently decided not to appeal, and the ban took effect on September 12, 2005 as scheduled. (See KAW's press release commending Bayer for ceasing its opposition to the ban.)