By Ransdell Pierson and Charles Abbott
Dec 11 In a bid to stem a surge in human
resistance to certain antibiotics, U.S. regulators announced new
guidelines to phase out their use as a growth enhancer in
The Food and Drug Administration said the antibiotics could
still be used to treat illnesses in animals raised for meat, but
should otherwise be pared back over the next three years under a
voluntary program to keep them out of the human food supply.
Although voluntary, the agency said it expects drugmakers to
fully adhere to the new guidelines and on Wednesday announced
that two of these biggest purveyors of those antibiotics had
already agreed to narrow their use.
Doctors and hospitals have become increasingly worried in
recent years by new strains of bacteria that cannot be
controlled by a wide range of current antibiotics. Part of the
suspected reason for the emergence of these "superbugs" is that
people who have eaten meat that contained antibiotics develop
resistance to the drugs as bacteria mutate to thwart them.
"Because antimicrobial drug use in both humans and animals
can contribute to the development of antimicrobial resistance,
it is important to use these drugs only when medically
necessary," the FDA said in a release.
In guidance issued on Wednesday, the FDA asked global
drugmakers and animal health companies including Eli Lilly & Co
and Zoetis to revise labels of medically
important antibiotics by removing references to use in animal
Once companies remove farm production uses of their
antibiotics from drug labels, it would become illegal for those
drugs to be used for those purposes, Deputy FDA Commissioner
Michael Taylor said in a conference call with journalists. The
agency said about 25 animal health companies could be affected
by the guidelines, especially Lilly and Zoetis.
Although the program is meant to be voluntary, Taylor said
the FDA would be able to take regulatory action against
companies that fail to comply.
The FDA's "final guidance," also brings the drugs under
oversight of veterinarians by changing the over-the-counter
status of the products.
The FDA said it will require animal pharmaceutical companies
to notify the agency within three months of their intent to
adopt its strategy. The companies would then have three years to
complete the transition process.
CRITICS QUESTION ENFORCEMENT
Critics on Wednesday said the guidelines give drugmakers too
much discretion in policing their own use of antibiotics.
Democratic lawmaker Louise Slaughter called the FDA move an
inadequate response to the overuse of antibiotics "with no
mechanism for enforcement and no metric for success."
Her view was echoed by consumer and environmental advocacy
"Our fear ... is that there will be no reduction in
antibiotic use as companies will either ignore the plan
altogether or simply switch from using antibiotics for routine
growth promotion to using the same antibiotics for routine
disease prevention," said Steven Roach, senior analyst with
advocacy group Keep Antibiotics Working.
Morningstar analyst David Krempa said the FDA issued similar
voluntary guidelines in April 2012, meant to limit use of
important antibiotics in food-producing animals, but they appear
to have been largely ignored by farmers.
He said compliance with the FDA's latest set of voluntary
guidelines could be equally spotty.
"Compliance will be tough because all the farmers and meat
producers know these products increase the size of their
animals," Krempa said. "They can continue to use them, and just
say there's a disease going through their herds."
But even if antibiotics use in livestock indeed comes down,
Krempa said it would be only a "small negative" for Zoetis
because it, like other animal health companies, sells such a
wide range of products for both livestock and pets.
The FDA said it had already received support for the new
measures from Zoetis and Elanco, a unit of Eli Lilly, which sell
a large percentage of the products that will eventually be
Elanco said in a statement that it would voluntarily narrow
use of antibiotics used to treat both humans and animals "only
to therapeutic purposes of treating, controlling and preventing
diseases in animals under the supervision of a veterinarian."
Other companies with animal health businesses include Merck
& Co, Novartis AG, Sanofi and Bayer
Bayer and Sanofi said the FDA strategy would not affect the
types of products they sell, but both companies said they
support the FDA's position.
"It is important that these medically important antibiotics
are used responsibly and with veterinary oversight," a Bayer