FDA revokes approval of Baytril use in poultry
The battle over Baytril, the controversial fluoroquinolone antibiotic
that industry figures say is essential to ensuring animal health and
public interest groups call a dangerous promoter of antibiotic
resistance, seems to be all but over with the release of an FDA decision
revoking approval for the drug's use in poultry.
"I find...that enrofloxacin [Baytril] is not shown to be safe for use in
poultry under the approved conditions of use...I therefore am
withdrawing the approval of the NADA [New Animal Drug Application] for
use of enrofloxacin in poultry," FDA Commissioner Lester Crawford wrote
in the July 28 decision.
The action comes after a five-year struggle between Bayer, which
manufactures Baytril (the animal equivalent of the human drug Cipro),
and the agency over the drug's role in promoting antibiotic resistance
among Campylobacter infections in humans. The battle began in October
2000, when FDA's Center for Veterinary Medicine (CVM) proposed to remove
the drug from the poultry market. In response, Bayer and the Animal
Health Institute (AHI) filed requests for a hearing before an
Administrative Law Judge (ALJ) to contest the proposal.
In 2004, the ALJ determined that the use of Baytril in poultry led to
populations of resistant Campylobacter that could be transferred to
humans and "have the potential to adversely affect human health." The
ALJ also noted that in light of an increase in antibiotic-resistant
Campylobacter infections in humans since Baytril's introduction, Bayer
had not "shown Baytril use in poultry to be safe." Bayer contested the
ALJ's decision, submitting a 234-page appeal taking exception on legal
and factual grounds.
Crawford, however, was apparently unconvinced by Bayer's argument,
noting in his ruling that "large portions of Bayer's exceptions do not
comply" with the strictures set for exceptions, and that "many of
Bayer's exceptions are frivolous or trivial. Bayer's lengthy filing
contains sentences, paragraphs and even whole pages that completely lack
any citation to the record." Crawford also denied Bayer's request for
another oral hearing.
Reactions polarized
"I think it's a big deal," said Margaret Mellon, director of food and
environmental programs at the Union of Concerned Scientists, in a
conversation with Food Chemical News. "I think that what it means is,
barring another appeal by Bayer, that this is going to be the first
instance in which FDA has cancelled a veterinary drug based on
resistance concerns. It shows that FDA understands the gravity of the
public health risk presented by antibiotic resistance. The agency has
gone about this with some tenacity. They really ought to be applauded
for this," she said.
Her comments were echoed by other public interest groups. "FDA's strong
action today will help combat bacterial resistance to this important
drug and preserve its ability to treat tens of thousands of Americans
sickened each year by contaminated poultry," said Jean Halloran,
Director of Food Policy Initiatives at Consumers Union.
Initial reaction from industry was understandably more downbeat. "We are
disappointed by the decision of the FDA Commissioner to accept the
findings of the administrative law judge and order enrofloxacin used to
treat sick poultry to be removed from the market. The loss of this
product leaves poultry producers without an important tool to treat sick
poultry, and it will reduce animal health and welfare while increasing
animal death and suffering," said AHI's Ron Phillips.
Bayer did not respond to a request for comment by press time. The
company has 60 days to file an appeal to Crawford's ruling, which
otherwise will go into effect Sept. 12.
- Zachary Richardson [email protected]Food Chemical News
