producers, who administer low-level
doses of antibiotics to entire herds or
flocks of animals for long durations, usually through feed, without targeting any
specific disease. Low doses of antibiotics are linked to resistance. Given such
long-term and widespread use, the FDA
says growth promotion represents a substantial proportion of the overall use of
antibiotics in agriculture, although it has
no specific data.
There has been some concern
among public health groups over the
FDA’s continued approval of antibiotics for preventive use. Dr. Robert S.
Lawrence, professor at the Johns Hopkins
Bloomberg School of Public Health, wrote
in a piece for The Atlantic that like growth
promotion, preventive use involves low
doses “that are equally culpable in the
development of antibiotic resistance.” The
FDA maintains that in some cases preventive use is “necessary and judicious”
under veterinary supervision.
Public health groups also have
expressed concern that the guidance is
voluntary rather than compulsory.
“In the FDA world, ‘voluntary’ means
something different,” Phillips rebuts.
“The guidance means that this is the
FDA’s approach, and basically that if you
want to work with the FDA, this is the
way you’re going to do it.”
The FDA has said it will assess adop-
tion levels after a three-year period.
increased demand for veterinary supervision could cause a shortage of care. In
many regions, large-animal veterinarians
are hard to find in the first place.
“For small producers who don’t have a
vet on staff … or even those in really remote
areas without easy veterinary access, this
has the potential to be a big issue,” says
Liz Wagstrom, chief veterinarian for the
National Pork Producers Council.
Livestock producers also fear that by
limiting the use of antibiotics, instances
of illness and disease in animals will rise,
which would lead to producers treating
them with antibiotics in higher dosages
than would have been used for growth
promotion. “Is it better to use a low
dose in an entire population or to use
increased doses at select times? The science gets hazy here,” Minahan says.
Not all producers oppose or fear the
changes. Stephen McDonnell, the
founder and CEO of Applegate Farms,
an organic meat and cheese producer
that works with a network of nearly
1,000 family farmers, says his company has seen success and growth over
25 years using an antibiotic-free model.
“Producers need to look at these changes
as an opportunity, not a challenge,” he
said in an email.
Wagstrom advises that producers do
anything they can to improve management, which is how Danish producers say
they survived the country’s similar 1998
ban on nontherapeutic use.
The FDA’s April guidance is another
step in its evolving approach toward
antibiotics use in livestock. In January,
it took the small step of banning certain
off-label animal uses of cephalosporins, a
class of antibiotics used in both animals
and humans. Minahan says that ban got
the ball rolling.
“I tell my clients to plan ahead and
start transitioning their production
[according to what] they think the FDA’s
going to do in the future,” Minahan says.
“Unless you come up with something that
shows antibiotics are not creating anti-biotic-resistant bacteria, you’re going to
have a hard time reversing this trend.” n
The FDA calls for veterinarians to supervise use of antibiotics that go into animal
feed and requires a statement from them
stipulating details of use—how long it is
given, how much is administered and how
it’s distributed among herds, for example.
“It becomes very cumbersome, almost
tedious,” Minahan says of the process.
Livestock producers fear their operating
costs will grow substantially because of
an increased need for veterinary oversight. What’s more, Minahan says, the
For the makers oF animal antibiotics, losing one oF Four label
claims for the drugs—and requiring veterinary supervision over therapeutic
uses—will surely have an effect on sales.
“clearly, if [animal health producers] lose growth claims, there’s going to be
some economic pain associated with that,” says ron Phillips, vice president for
legislative and public affairs for the animal health institute (ahi), which represents animal drug developers and producers.
the Fda’s draft guidance outlines how drug makers can convert growth
claims to prevention claims by submitting data through a new animal drug
approval process showing that the product is effective against a specific bacteria or disease—one of the key differences between growth claims and the other
three therapeutic claims. it will be a lengthy and costly process, but Phillips says
drug makers have expressed interest in it.
liz Wagstrom, chief veterinarian for the national Pork Producers council,
says it’s unclear whether and to what extent producers will apply for new label
claims. “because [many of these drugs] are very old products, it’s very uncertain whether any of the animal health companies will actually try to change their
claims/labels,” she says.