The study by the NRDC, a non-governmental group that
criticizes the widespread use of drugs in the meat industry, is the
latest salvo in the national debate over the long-standing practice
of antibiotic use in meat production. Agribusinesses say animal
drugs help increase production and keep prices low for U.S.
consumers, while consumer advocates and some scientists raise
concerns over antibiotic-resistant bacteria.
The FDA stirred the debate late last year when it unveiled
guidelines for drug makers and agricultural companies to voluntarily
phase out antibiotic use as a growth enhancer in livestock. The
agency said those guidelines were an effort to stem the surge in
human resistance to certain antibiotics.
But the NRDC's study found the FDA took no action to remove 30
antibiotic-based livestock feed products from the market even after
federal investigators determined many of those antibiotics fell
short of current regulatory standards for protecting human health.
NRDC studied a review conducted by the FDA from 2001 to 2010 that
focused on 30 penicillin and tetracycline-based antibiotic feed
additives. The drugs had been approved by regulators to be used
specifically for growth promotion of livestock and poultry — essentially to produce more meat to sell.
The FDA, in a statement, said it began a review of older, approved
penicillin and tetracycline products in 2001, and issued letters to
companies who made the products asking for additional safety data.
"Based on its review of this and other information, the Agency chose
to employ a strategy that would more broadly address the concerns
about the production use of medically important antimicrobials in
food-producing animals," the FDA said.
Some academics specializing in antibiotic resistance criticized the
NRDC's study, saying that the findings do not reflect current
regulatory standards because some of the drugs have been withdrawn
from the market.
They also say that the study assessed FDA safety guidelines that
have been replaced with more stringent standards.
Dr. Randall Singer, associate professor of epidemiology at the
University of Minnesota, told Reuters that drug makers and the U.S.
livestock industry are phasing out antibiotics used principally for
"We have been telling (both of) them for years to be prepared for
the elimination of growth promotion and feed efficiency labeling
because you cannot make that change overnight," said Singer, who
reviewed the NRDC report for Reuters.
The NRDC, which reviewed more than 3,000 pages of documents through
a federal Freedom of Information Act request, said it found evidence
to suggest nine of the drugs are still on the market and used by
livestock producers. Reuters was not able to independently verify
that detail immediately.
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One of the drugs still on the market is animal health company
Zoetis Inc's Penicillin G Procaine 50/100, which is fed to poultry
in part to aid in weight gain.
The NRDC says the FDA twice laid out its concerns to that drug
maker that the product failed to meet safety regulations. The
unnamed original sponsor of the drug apparently disputed the
regulators' findings, according to excerpts from a 1997 letter sent
to the FDA and included in documents obtained by the NRDC.
A spokeswoman for Zoetis, a unit of Pfizer Inc that owns the drug
today, said the company already is working to phase out use of the
drug for growth promotion as part of the new FDA guidelines and is
planning to relabel the drug for more limited purposes.
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 told
reporters recently. 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.
In its statement on Monday, the FDA said it is "confident that
its current strategy to protect the effectiveness of medically
important antimicrobials, including penicillins and tetracyclines,
is the most efficient and effective way to change the use of these
products in animal agriculture."
NRDC attorney Avinash Kar, one of the study's authors, said the
group's findings raise questions about whether regulators will be
effective in enforcing the new guidelines.
"The FDA's failure to act on its own findings about the 30 reviewed
antibiotic feed additives is part of a larger pattern of delay and
inaction in tackling livestock drug use that goes back four
decades," Kar told Reuters.
(Reporting by P.J. Huffstutter in
Chicago and Brian Grow in Atlanta; editing by David Greising, Amanda
Kwan and Kenneth Maxwell)
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