Even though a new animal drug product is carefully tested before
it is marketed, wider use of the product may disclose problems
not evident during the pre-marketing research. Therefore, the
assessment of the safety of a new drug is a continuing process
that takes place throughout the development and marketing of
a drug. Post-marketing surveillance is the process for assessing
drug safety.
The CVM's Office of Surveillance and Compliance (OS&C),
in cooperation with the FDA Field Offices, monitors marketed
animal drugs, food additives, and veterinary devices to assure
their safety and effectiveness. This regulatory responsibility
is carried out by scientists, investigators, and analysts around
the country. Also involved in these activities are the Department
of Agriculture (USDA), the Environmental Protection Agency (EPA),
and other State and Federal agencies. Federal field investigators
and State inspectors conduct inspections of medicated feed manufacturers
to assure that acceptable manufacturing procedures are followed.
Violations can result in regulatory action.
Functions among the OS&C Divisions are varied, yet closely
related. One Divisions function is the overseeing of medicated
animal feeds. Another involves monitoring drugs used in food
and non-food animals, and providing scientific expertise for
legal cases. Another is to monitor antibiotic resistance in
animal derived foods. Another Divisions function is to
monitor Compliance of the industry by working cooperatively
with the other OS&C Divisions, educational outreach to the
field and industry and to pursue regulatory actions if warranted.
One of CVM's highest priorities is assuring the safety of animal
derived foods. Drugs are used in food-producing animals to treat
and prevent animal diseases, and to increase animal production.
Contaminants in animal feeds can have an impact on human food
safety.
The National Antimicrobial Resistance Monitoring System (NARMS)
was established in January 1996 as a collaborative effort among
the FDA, USDA, and CDC. The system was initiated in response
to public health issues associated with the approval of fluoroquinolone
products for use in poultry. The NARMS monitors changes in susceptibilities
to 17 antimicrobial drugs of zoonotic enteric pathogens from
human and animal clinical specimens, from healthy farm animals,
and from carcasses of food-producing animals at slaughter.
Important augmentations of the NARMS were made possible by
funding from the Presidents National Food Safety Initiative
(FSI). These augmentations include expanding the scope of the
monitoring system and conducting follow-on research and investigations.
The most important expansion of the monitoring system has been
to include Campylobacter and E. coli isolate testing and reporting,
in addition to Salmonella, from animal sources.
With the additional funding provided by the FSI, epidemiologic
research also was initiated. This research is to characterize
and reduce the incidence of foodborne disease associated with
emerging and drug-resistant pathogens and includes a field study,
several farm-based efforts, and molecular genetic research.
Recognizing the need to maintain a balance between the health
of food animals and maintaining the safety and effectiveness
of human antimicrobials, CVM/OS&C has requested drug sponsors
to provide information, in the form of Post-Approval Monitoring
Programs (PAMPs), during the marketing period for those food
animal new animal drugs that are of public health concern. PAMPs
are designed to provide FDA with information related to changes
in antimicrobial susceptibility of foodborne pathogens in animals
that may be exposed to the drug under actual growth conditions
The U.S. Department of Agriculture's Food Safety and Inspection
Service (FSIS) is responsible for the inspection of meat and
poultry products in Federally-inspected establishments and has
primary responsibility for the wholesomeness of these products.
FSIS reports violative residues of drugs in meat and poultry
to FDA for regulatory follow-up.
FDA and State agencies, under inspectional agreements with
FDA, conduct follow-up inspections of producers or others involved
in the production or marketing of food animals or poultry which
have tissue residue violations. The goal of CVM's Tissue Residue
Program is to eliminate violative drug residues in edible tissue
of food animals.
The National Drug Residue Milk Monitoring Program (NDRMMP)
is another effort to ensure milk safety. The NDRMMP routinely
tests raw milk for drug residues. It is a cooperative effort
between FDA and State milk control officials. Milk samples are
assayed for eight sulfonamide and three tetracycline drugs,
chloramphenicol, and the beta lactam antibiotics. Analytical
methods for more compounds are added as they are developed.
Additional functions of the OS&C include:
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Approves food additive petitions after determining their
safety and utility.
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Approves Medicated Feed Mill Licenses after ensuring the
sponsoring firm is operating in compliance with good manufacturing
practice.
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Monitors animal feeds with regard to their safety to the
animals which receive them, to the public who consume the
food products derived from treated animals, and to the environment.
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Monitors approved veterinary drugs and food additives to
assure their continued safety and effectiveness.
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Monitors marketed unapproved veterinary drugs and veterinary
devices.
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Enforces industry compliance with the FFDCA by evaluating
and coordinating legal cases brought against violators by
the Agency.
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Reviews product labels and provides assessments of their
status.
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Withdraws drugs and food additives from the market when
conditions warrant removal, based on scientific fact concerning
a lack of safety and/or effectiveness
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Assures that good laboratory practices are maintained,
through the monitoring of laboratory investigators who conduct
studies as part of the NADA approval process. Monitors the
conduct of clinical investigators and sponsors of clinical
investigations.
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Continuously monitors and evaluates reports of adverse
drug experiences for animal safety and public health issues.
Withdrawal of an approved drug may be recommended if it
is determined to be unsafe or ineffective.
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Collaborates with USDA/FSIS on drugs and chemicals in meat
and poultry.
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Develops and implements policies that affect marketed products.
Updated July 5, 2000 at 8:23 PM ET
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