WHY GAO DID THIS STUDY
Antibiotic resistance is a growing
public health concern; antibiotics
used in animals raised for human
consumption contributes to this
problem. Three federal agencies
address this issue—the Department
of Health and Human Services’
(HHS) Food and Drug
Administration (FDA) and Centers
for Disease Control and Prevention
(CDC), and the Department of
Agriculture (USDA). GAO
examined (1) scientific evidence on
the transference of antibiotic
resistance from animals to humans
and extent of potential harm to
human health, (2) agencies’ efforts
to assess and address these risks,
(3) the types of data needed to
support research on these risks and
extent to which the agencies
collect these data, (4) use of
antibiotics in animals in the United
States compared with its key
agricultural trading partners and
competitors, and (5) information
on how use has affected trade.
WHAT GAO RECOMMENDS
GAO recommends that (1) FDA
expedite its risk assessments of
drugs used in animals that are
critical for human health and
(2) USDA and HHS develop and
implement a plan to collect data on
antibiotic use in animals. USDA
and HHS generally agreed with
GAO’s findings. With respect to the
recommendations, HHS agreed that
it is important to review animal
drugs that are critical to human
health and both agencies discussed
ways to better collect antibiotic use
data.
To view the full report, including the scope
and methodology, click on the link above.
For more information, contact Anu Mittal at
(202) 512-3841 or Marcia Crosse at (202)
512-7119.
|
What GAO Found
Many studies have found that the use of antibiotics in animals
poses significant risks for human health, but a small number of studies
contend that the health risks of the transference are minimal.
Federal agencies have expanded their efforts to assess the extent of
antibiotic resistance, but the effectiveness of their efforts to reduce human
health risk is not yet known. FDA, CDC, and USDA have increased their
surveillance activities related to antibiotic resistance. In addition, FDA has
taken administrative action to prohibit the use of a fluroquinolone in poultry.
FDA has identified animal drugs that are critically important for human
health and begun reviewing currently approved drugs using a risk
assessment framework that it recently issued for determining the human
health risks of animal antibiotics. However, because FDA’s initial reviews of
approved animal drugs using this framework have focused on other drugs
and have taken at least 2 years, FDA’s reviews of critically important drugs
may not be completed for some time.
Although federal agencies have made some progress in monitoring antibiotic
resistance, they lack important data on antibiotic use in animals to support
research on human health risks. These data, such as the type and quantity of
antibiotics and purpose for their use by species, are needed to determine the
linkages between antibiotic use in animals and emerging resistant bacteria.
In addition, these data can help assess human health risks from this use and
develop and evaluate strategies for mitigating resistance.
The United States and several of its key agricultural trading partners and
competitors differ in their use of antibiotics in animals in two important
areas: the specific antibiotics allowed for growth promotion and availability
of antibiotics to producers (by prescription or over the counter). For
example, the United States and Canada allow some antibiotics important in
human medicine to be used for growth promotion, but the European Union
(EU) and New Zealand do not. Regarding over the counter sales of
antibiotics, the United States is generally less restrictive than the EU.
Antibiotic use in animals has not yet been a significant factor affecting U.S.
international trade in meat and poultry, although the presence of antibiotic
residues in meat has had some impact, according to government and
industry officials. Instead, countries raise other food safety issues, such as
hormone use and animal diseases. However, according to these officials,
antibiotic use in animals may emerge as a factor in the future. They
particularly noted that the EU could object to U.S. use of antibiotics for
growth promotion as its member countries are phasing out that use.
Source: United States General Accounting Office - May 2004
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4 July 2004
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