Washington, DC – The Keep Antibiotics Working Coalition (KAW)
applauded the efforts of the U.S. Food and Drug Administration
to release a final Guidance Document (Guidance #152) on
agricultural antibiotics today. However, KAW expressed its deep
disappointment that FDA failed to provide a timetable for
taking action to reduce the massive amounts of medically
important antibiotics that are now routinely fed to livestock
and poultry. As a result, the Guidance will not suffice to help
preserve the effectiveness of medically important antibiotics
for treating human illness. (While the Guidance itself does not
appear to expressly state that FDA will review existing
approvals, the agency’s briefing materials on the Guidance
state that it “will lead to review of all existing approvals.”)
KAW also voiced concerns about certain aspects of the Guidance
as revised.
An estimated 70% of the antibiotics used each year in the
U.S. are fed to livestock and poultry – not to treat illness,
but to promote slightly faster growth and to prevent disease
that would otherwise result from crowded, stressful, and
unhygienic conditions. More than half of those antibiotics are
identical or related to medicines used in human treatments. In
March 2003, the National Academy of Sciences called for
“substantial efforts” to reduce overuse of antibiotics in
agriculture.
“The FDA missed a crucial opportunity to improve on the
earlier draft of the guidance by setting specific timeframes to
act on the overuse of antibiotics in animal agriculture,” said
Margaret Mellon, Ph.D. from the Union of Concerned Scientists.
“By the agency's own admission, FDA's current process takes six
to twenty years to remove a single agricultural drug or drug
class from the market. So business-as-usual means it would take
a half-century or more to address the eight classes of
medically important antibiotics that are now used as feed
additives. FDA’s complete silence as to when it will even
initiate – much less complete – reviews for antibiotic feed
additives altogether misses the 800-pound gorilla in the room.”
“The real test will be in how the guidance is applied,”
added Mellon.
Because of FDA’s inability to take action in a timely
manner, KAW supports “The Preservation of Antibiotics for
Medical Treatment Act” (S.1460/H.R.2932), introduced by
Senators Edward Kennedy (D-MA) and Olympia Snowe (R-ME) and
Congressmen Sherrod Brown (D-OH) and Wayne Gilchrest (R-MD).
The legislation creates a two-year phase out for the eight
classes of medically important antibiotics now used as feed
additives for farm animals, but does not restrict use of these
antibiotics to treat sick animals or their non-routine use to
control the spread of disease. More than 280 organizations,
including the American Medical Association and the American
Public Health Association, have endorsed the legislation since
its introduction in July.
In addition to its serious concern about the Guidance’s lack
of specific timelines for action on already-approved
antibiotics, KAW noted that the final Guidance has some
significant weaknesses. “While the Guidance sets out a sensible
conceptual strategy for evaluating the safety of antibiotic use
in agriculture, there are some serious weaknesses in it,” said
John Balbus, M.D. of Environmental Defense. “It fails to
address certain key issues, notably non-food pathways such as
environmental contamination. Nor does it appear to adequately
provide for consideration of co-selection and cross-resistance,
or to assure protection of highest-value drugs that don’t
happen to be used in treating food-borne illness. And the
timing issues for existing approvals remain urgent.”
Keep Antibiotics Working (www.KeepAntibioticsWorking.com) is
a coalition of health, consumer, agricultural, environmental,
humane and other advocacy groups with more than nine million
members dedicated to eliminating a major cause of antibiotic
resistance – the inappropriate use of antibiotics in farm
animals. The Humane Society of the United States is a member of
the coalition.
