Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005
ANIMAL DRUGS AND FEEDS
|
FY 2003
Actual |
FY 2004
Enacted 1/ 2/ |
FY 2005
Estimate |
Increase
or Decrease |
Program Level |
$87,659,000 |
$88,897,000 |
$99,299,000 |
+ $10,402,000 |
Center |
$57,115,000 |
$59,705,000 |
$63,485,000 |
+ $3,780,000 |
FTE |
341 |
355 |
376 |
+ 21 |
Field |
$30,544,,000 |
$29,192,000 |
$35,814,000 |
+ $6,622,000 |
FTE |
255 |
276 |
296 |
+ 20 |
Budget Authority |
$87,659,000 |
$84,147,000 |
$91,905,000 |
+ $7,758,000 |
Cost of Living--Pay 3/ |
|
|
$1,134,000 |
+ $1,134,000 |
Bovine Spongiform
Encephalopathy |
$15,811,000 |
$15,624,000 |
$23,649,000 |
+ $8,025,000 |
Administrative Efficiencies |
|
|
- $1,401,000 |
- $1,401,000 |
FTE |
|
|
- 12 |
- 12 |
Budget Authority FTE |
596 |
591 |
614 |
+ 23 |
User Fees |
|
$4,750,000 |
$7,394,000 |
+ $2,644,000 |
ADUFA 4/ |
|
$4,750,000 |
$7,394,000 |
+ $2,644,000 |
FTE |
|
40 |
58 |
+ 18 |
User Fee FTE |
|
40 |
58 |
+ 18 |
1/Contains
a Budget Authority rescission of 0.59 percent for a total of $499,000
for Animal Drugs and Feeds.
2/ In FY 2004, a total of 104 Human Resources FTE were transferred
from the FDA to the Department as part of the Secretary's One HHS Initiative.
The Animal Drugs and Feeds Program's share of this transfer was 5.
3/ Pay increases shown on separate line, and not reflected
in individual initiative areas.
4/ For the purposes of the FY 2005 budget, FDA has assumed
ADUFA's appropriations have been enacted and is in its second year. |
Historical Funding and FTE Levels
Fiscal Year |
Program Level |
Budget Authority |
User Fees |
Program Level FTE |
2001 Actual |
$64,070,000 |
$64,070,000 |
$0 |
442 |
2002 Actual 5/ |
$85,643,000 |
$85,643,000 |
$0 |
570 |
2003 Actual |
$87,659,000 |
$87,659,000 |
$0 |
596 |
2004 Enacted |
$88,897,000 |
$84,147,000 |
$4,750,000 |
631 |
2005 Estimate |
$99,299,000 |
$91,905,000 |
$7,394,000 |
672 |
5/Includes
FDA's FY 2002 Appropriation and the Counterterrorism Supplemental. |
MISSION
The Animal Drugs and Feeds Program is responsible for ensuring that animal
drugs and medicated feeds are safe and effective for intended uses and that
food from treated animals is safe for human consumption. The aim of the program
is to:
- Foster public and animal health by approving safe and effective products
for animals and by enforcing applicable provisions of the Federal Food, Drug,
and Cosmetic Act, and other authorities;
- Process premarket applications as quickly as possible to increase the availability
and diversity of safe and effective veterinary products that relieve animal
pain and suffering while ensuring the resulting products are safe, wholesome,
and free of drug residue when they reach the consumer; and,
- Monitor marketed products for all animal drugs and feeds to minimize harm
to humans or animals that might arise from the use of these products. This
is accomplished through science-based review of drug experience reports, nationwide
monitoring systems, compliance programs conducted by FDA field offices through
inspections, sample collections and analysis, investigations, and appropriate
regulatory actions to control violative goods and firms.
BACKGROUND
The Animal Drugs and Feeds Program (Program) is administered by FDA's Center
for Veterinary Medicine (CVM) and supported by the Office of Regulatory Affairs'
(ORA) field force. The authority to regulate animal drugs and medicated feeds
is derived from the Food, Drug, and Cosmetic Act, which in 1968 was amended
to include sections specifically addressing animal drugs. These amendments were
designed to ensure that animal drugs are safe and effective for their intended
uses and that the drugs do not result in unsafe residues in foods.
The Animal Drugs and Feeds Program scope is far-reaching.
The program's customers include:
- 115 million dogs and cats
- 6.9 million horses
- 7.5 billion chickens
- 292 million turkeys
- 109 million cattle
- 92 million pigs
- 7 million sheep
- 280 million humans in the U.S.
|
The safety of the food supply is a paramount concern for the Program, as the
average American consumes nearly 200 pounds of meat and fish, 30 pounds of eggs,
and 600 pounds of dairy products each year. While most of these food products
are regulated by the Department of Agriculture, FDA plays an important role
in ensuring that animal drugs and feeds used in the care of these animals do
not result in unsafe residues in food products that are harvested or produced
(e.g., eggs) from these animals. The Program's other priorities are animal drug
review, antibiotic resistance, prevention of Bovine Spongiform Encephalopathy
(BSE) or "mad cow disease", and the safety of food derived from genetically
modified animals.
Of these priorities, the Program's BSE efforts have sought to limit the exposure
of BSE in the food and feed supply through a program of regulation and enforcement.
In 1997, FDA issued a regulation prohibiting the use of most animal proteins
in feeds for cattle and other ruminants. In its enforcement strategy, FDA initiated
a comprehensive inspectional program using the Field and its State partners
covering 100 percent of the affected industry. With its educational emphasis
and other outreach efforts, the result has been that more than 99 percent of
all renderers and feed mills in the U.S. are in compliance with the 1997 regulation.
The ORA field force supports the Program by conducting inspections of both
foreign and domestic establishments and bioresearch monitoring of clinical research;
and inspections of manufacturing facilities to determine if the factory is able
to manufacture the product to the specifications stated in the application.
The Field also conducts risk-based domestic and foreign postmarket inspections
of animal drug manufacturers to assess their compliance with Good Manufacturing
Practice and biennial inspection requirements, and monitoring and sampling imports
to ensure the safety of animal drugs and feed products. In addition to overseeing
regulated products on a surveillance or "for cause" basis when a problem
is encountered, ORA staff also responds to emergencies and investigates incidents
of product tampering and terrorist events or natural disasters that may impact
FDA-regulated goods. To complement the regular field force, the Office of Criminal
Investigations (OCI) investigates instances of criminal activity in FDA regulated
industries.
Animal Drugs and Feeds Program
Increases for FY 2005
By FDA Strategic Goal |
FDA Strategic Goal |
FY 2005 Increase |
What the Increase Buys |
Related Performance Goal(s) |
Strong FDA |
Cost of Living-Pay -- + $1,134,000 |
- Review and act on animal drug applications (new, investigational,
and generic) and reactivations; and,
- Monitor marketed animal drugs and medicated feeds to minimize harm
to humans or animals.
|
- Complete review and action on 90 percent of original NADAs and reactivations
received in FY 2005 within 270 days.
|
Efficient Risk Management: The Most Public Health Bang for our Regulatory
Buck |
Bovine Spongiform Encephalopathy (BSE) --
+ $8,025,000 |
- Conduct additional risk based BSE inspections and targeted sample
collections and analyses of animal feed or feed components;
- Improve data quality and data management practices to better monitor
industry compliance and improve the usefulness of state data; and,
- Conduct outreach to inform industry of the requirements to prevent
BSE from contaminating animal feed.
|
- Maintain biennial coverage by inspecting 50 percent of 1,440 registered
animal drugs and feed establishments; and,
- In conjunction with state inspections, conduct targeted BSE inspections
of 100 percent of all known renderers and feed mills processing products
containing prohibited material.
|
PROGRAM RESOURCES CHANGES
Budget Authority
Cost of Living- Pay: + $1,134,000
FDA's request for pay cost increases is essential to accomplishing its mission.
Without a specially trained national cadre of scientific staff, FDA's ability
to adequately carry out the mission of protecting public health and providing
consumer safety will be compromised. FDA must maintain staffing levels and scientific
capabilities that meet the demands of an increasing workload and new challenges.
Payroll costs, which account for over 60 percent of our total budget, significantly
impact all FDA activities.
The total Agency request for pay increases is $14,352,000. The Animal Drugs
and Feeds portion of this increase is $1,134,000. Without this, the FDA's ability
to fulfill its mission to protect the public health by helping safe and effective
products reach the market in a timely way, and monitoring products for continued
safety after they are in use will be significantly reduced.
Bovine Spongiform Encephalopathy (BSE): + $8,025,000 and + 35 FTE
In responding to the discovery of a cow infected with BSE in Washington State,
the USDA implemented additional safeguards to protect the nation's food supply
from further outbreaks. In supporting these USDA safeguards, FDA announced that
it would increase its efforts to meet its expanded responsibilities for protecting
the safety of the food and feed supply. With the increase funding in FY 2005,
FDA will fund the following activities:
- Educate industry on requirements of new/updated regulations and the impact
to their practices;
- Increase funding of state BSE inspections, on-farm BSE inspections, and
BSE monitoring and control infrastructure grants so that the states can perform
an additional 2,500 inspections, improve state and federal information on
the inventory of animal feed firms and firms handling prohibited materials,
and strengthen state infrastructure to monitor, and respond to potential feed
contamination with prohibited materials;
- Increase funding for field BSE inspections, sample collections and analyses
so that FDA can perform an additional 920 risk-based BSE inspections and an
additional 600 targeted sample collections and analyses of animal feed or
feed components;
- Increase the funding of field investigator training, state coordination,
and industry outreach to expand investigational efforts to industry sectors
vulnerable to cross contamination, such as truckers, on-farm mixers and distressed
or salvaged food; improve data quality and data management practices so that
FDA can better monitor industry compliance and improve the usefulness of state
data; and conduct industry outreach to better inform industry of responsibilities
and opportunities to prevent BSE from contaminating animal feed;
- Improve inventory of firms by keeping it updated based on information in
mandatory feed registration system;
- Analyze and audit BSE reported inspectional information which will determine
where additional inspection and education is needed;
- Enhance the ability to respond efficiently to for-cause follow-up actions;
and,
- Evaluate the effectiveness of commercial tests to detect ruminant proteins
in animal feeds, and initiation migration of current polymerase chain reaction
methods into new technologies to allow for more rapid analyses of samples.
Administrative Efficiencies: - $1,401,000 and - 12 FTE
To fully embrace the President's Management Agenda, FDA is delayering its
organizational structure, performing competitive sourcing reviews, modernizing
its financial management system, and consolidating its information technology
infrastructure. The Animal Drugs and Feeds program portion of these management
improvements consists of - $1,401,000 and - 12 FTE.
User Fee
Animal Drug User Fee Act (ADUFA): + $2,644,000 and + 18 FTE
The Animal Drug User Fee Act, enacted into law on November 18, 2003 (P.L. 108-130),
will ensure the availability of safe and effective animal drugs benefiting both
food producing and companion, service animals. These safe and effective animal
drugs will allow food animal producers to maintain healthy animals with the
assurance that resulting food products will be safe, wholesome, and free of
harmful drug residue. Ingestion of animal drug residues in food products could
potentially cause unsafe conditions for humans, ranging from drug allergies
to cancer. The availability of safe and effective drugs also ensures companion,
service animals that assist the disabled, and other animals such as zoo animals
will live healthier and longer lives. The Animal Drug User Fee Program which
requires new animal drug applicants, sponsors, and manufacturers to incur a
fee to expedite their respective applications, will help provide a cost-efficient,
high quality animal drug review process that is predictable and performance
driven. This fee has strong industry support and provides a complementary set
of incentives to all interested parties -- industry, consumers, Congress, and
FDA. This fee is modeled after the Prescription Drug User Fee Act, a successful
partnership between the Federal government and stakeholders to improve and expedite
the review of applications. The net increase of $2,644,000 will cover inflationary
costs, as well as overhead and rent costs, for additional staff associated with
the implementation of ADUFA.
PROGRAM ASSESSMENT RATING TOOL (PART)
In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human
Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological
Health) and was rated as "results not demonstrated" due to a lack
of long-term outcome goals. To address this concern, long-term outcome goals
were developed.
For FY 2005, the Office of Management and Budget conducted a second program
review that treated FDA as a single agency program. In this review, FDA received
a rating of "moderately effective" and score of 77 percent, up from
59 in FY 2004. This was due to considerable improvements in developing long-term
agency-wide outcome goals that will demonstrate its effectiveness and impact
on the public health. FDA also reduced the number of performance goals, and
made various management improvements that further streamline its infrastructure
while supporting core, mission-critical public health activities.
The Animal Drugs and Feeds Program shares in an agency-wide outcome goal of
reducing administrative overhead through the reduction of the number of administrative
staff. All of the Agency's outcome goals support the Department's priorities
and Administration's initiatives with the intent to improve the health and well-being
of the American public.
JUSTIFICATION OF BASE
EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY
BUCK
Base resources will be used to conduct science-based risk management in all
agency regulatory activities; so that the Agency's limited resources can provide
the most health promotion and protection at the least cost for the public. These
activities include compliance activities related to the BSE regulation; premarket
review; and, imports and inspections.
Bovine Spongiform Encephalopathy (BSE)
BSE or "Mad Cow Disease" is a deadly chronic, degenerative disorder
affecting the central nervous system. Feed containing remnants of the slaughtering
process, such as the brain and spinal cord, may harbor the agent that causes
BSE. To ensure such substances are not contained in animal feed, and to prevent
the establishment and amplification of BSE through animal feed, the FDA finalized
a regulation on August 4, 1997 entitled "Animal Proteins Prohibited from
use in Animal Feed". FDA will:
- Reinspect any firm found to be in violation of the regulation and inspect
other potentially affected firms to determine compliance with the regulation;
- Enforce the feed rule by conducting targeted BSE inspections of all known
renderers and feed mills processing products containing prohibited material,
such as meat and bone meal, on a yearly basis;
- Provide Federal and state inspectors with up-to-date information on BSE
feed regulations; European Union regulatory issues; Department of Homeland
Security and Department of Agriculture's Animal Plant and Health Inspection
Service authority; and best sampling practices;
- Ensure the BSE Feed Regulations are current to prevent the establishment
and amplification of BSE through animal feed;
- Maintain relationships with industry using telecommunication and conferences
to provide information on regulatory compliance and share inspection data;
- Maintain the new database and data entry procedures for BSE inspections,
and new BSE inspection checklist to target firms for re-inspections and to
collect better data from FDA and state inspectors;
- Leverage with state agencies by funding contract inspections of feed mills
and renderers, and conduct compliance, follow-up, and audit inspections to
state contracts;
- Collect and analyze domestic and import feed and feed component samples
for BSE related contaminants to ensure proper labeling of animal feeds and
feed components;
- Minimize and detect inadvertent problems associated with animal feed through
a risk-based control system in order to avoid adverse health consequences
in animals or humans;
- Develop and validate detection methods to for prohibited mammalian protein
in ruminant feed; and,
- Provide intensive line entry and label review of Animal Drug and Feed product
import line entries for use in domestic commerce.
Premarket Review
The availability of safe and effective animal drugs allows food animal producers
to maintain healthy animals with assurance that products will be safe, wholesome,
and free of harmful drug residues when they reach the consumer. Over time, animal
drug use has moved from therapeutic treatment to save animals intended for human
consumption, to the routine use of production drugs, which helps the producers
maintain a profit margin while keeping safe and wholesome animal products available
at a reasonable cost to the American consumer. FDA needs to improve product
review by keeping pace with the increased volume and complexity of review workload.
Keeping pace with technological advances will also improve the efficiency of
agency reviews, and decrease review time. FDA will:
- Increase the availability of safe and effective animal products, by reviewing
animal drug applications in a timely manner for safety and effectiveness,
and continue to work with regulated industry to minimize drug development
time;
- Reduce the backlog of pending submissions by developing new more meaningful
metrics to measure performance and distribute workload, and the design of
a "Back to Basics" strategy, including the development of a five-year
business plan and a project management tracking system;
- Continue pre-submission conferences, meetings, and workshops with industry,
and support electronic submission of applications;
- Improve the quality and timeliness of product reviews by monitoring pre-approval
inspections and expanding inspectional expertise in emerging technologies;
- Review previously approved new animal antimicrobial drug submissions with
respect to antimicrobial resistance and human food safety; and,
- Participate in the development of policy and practical guidance to industry.
- Conduct inspections of registered animal drug and feed establishments;
- Maintain biennial inspection coverage of animal drug and feed establishments;
- Develop additional laboratory analytical methods to permit analyses of products
for chemical and microbiological hazards, and perform laboratory validation
of analytical methods submitted to support pre-market product applications;
- Provide emergency operation, investigation and response for incidents involving
regulated domestic products;
- Conduct criminal investigations of reported product tampering, counterfeit
products and other fraudulent criminal activities involving regulated products;
and,
- Conduct bioresearch-monitoring inspections, which assure that product sponsors
are in compliance with regulations and good laboratory practices.
EMPOWERING CONSUMERS: IMPROVING HEALTH THROUGH BETTER INFORMATION
Base resources will be used to better enable consumers to make informed decisions
weighing benefits and risks of FDA-regulated products. These activities include:
- Deliver the food safety message to livestock producers, veterinarians, industry
and consumers via trade shows, videotapes, and pamphlets to educate them on
the risk of antimicrobial resistance of bacteria following the use of antibiotics
in food animals; and,
- Enhance the transparency of the National Antimicrobial Warning System (NARMS)
program to stakeholders, the public and other interested parties by increased
reporting and communications of NARMS results and program information by:
publishing Annual Reports of NARMS animal, human and retail meat data; posting
NARMS publication references on the web site, and presenting NARMS susceptibility
testing results at scientific meetings via poster or oral presentations.
IMPROVING PATIENT AND CONSUMER SAFETY
Base resources will be used to promote improved patient and consumer safety
by reducing risks associated with FDA-regulated products.
Food Safety
Millions of people get sick each year from food they eat. Some foodborne
illness is due to harmful or illegal residues in animal products while other
illness is due to microbiological infection. Concerns over chemical residues
have grown considerably over the past few years because of change in consumer
eating habits, such as eating more meals away from home and demanding seasonal
foods year round making transportation and refrigeration of foods increasingly
important. In order to safely manage animal drug use at home and abroad, we
must have the knowledge to make proactive, sound science based decisions. The
Agency will:
- Identify emerging resistance in foodborne pathogens through the NARMS which
contains three arms: human, animal and retail meat;
- Continue to enhance the transparency of the NARMS program to stakeholders,
the public, and other interested parties by increased reporting and communicating
of NARMS results and program information;
- Continue to accomplish the following using NARMS data: assess the human
health impact of the use in food-producing animals of antimicrobials that
are also used in human medicine; trigger broader research projects of prudent
antimicrobial use in animals, and determine the role of the environment in
the emergence and spread of antimicrobial resistance;
- Conduct research to identify food animal species causing human drug resistance;
- Supply data to Pulse Net on bacterial isolates of animal origin;
- Leverage FDA's Tissue Residue Information Management System with the USDA's
Residue Violation Information System to maintain tissue residue and feed contaminants
compliance programs;
- Detect chemical and microbial contaminants in the animal feed supply with
the maintenance of the Feeds Contaminants Compliance Program;
- Maintain early warning systems by collecting information from Drug Experience
Reports and Adverse Event Reports;
- Use new technologies in the development of multi-residue methods for the
detection of drug residues in imported aquaculture products;
- Conduct method validation studies required before applications for new drugs
for food producing animals can be approved;
- Provide educational information on biotechnology products and assist developers
through the regulatory process to the public;
- Reduce the transfer of resistant animal pathogens to humans by conducting
a risk assessment to assess the link between the use of virginiamycin in animals
and Synercid resistance in humans; and,
- Continue to support the World Health Organization's Global Salmonella Surveillance.
PROTECTING AMERICA FROM TERRORISM
Base resources will be used to strengthen FDA's capability to identify, prepare
for, and respond to terrorist threats and incidents.
The goals of the Animal Drugs and Feeds Program are to protect the health and
safety of all food producing, companion, and other non-food animals; and assure
that food from animals is safe for human consumption.FDA must work to develop
profiles of possible or probable food threats and points of attack and must
have the capacity to quickly and accurately identify outbreaks that may be happening
or about to occur at any point in the food chain, and take prompt action to
mitigate their effects. Base funding will enable FDA to:
- Assist state diagnostic laboratories in acquiring the scientific and analytical
expertise and capability to handle a feed contamination incident;
- Educate state veterinary offices about FDA's technical role in identifying
and responding to an intentional or accidental contamination of animal feed;
- Work with feed trade associations to develop biosecurity awareness guidelines
for the feed manufacturing industry;
- Developing rapid analytical methods for screening imports at the border;
- Review, assess and take appropriate enforcement action as a result of violations
discovered in inspections conducted or samples collected. This includes follow-up
actions as a result of intentional contamination;
- Assure immediate assessment and identification of good manufacturing practices
compliant facilities to ensure continued availability of veterinary drug products
and increase supply of pivotal drug products to meet emergency needs;
- Maintain a comprehensive inventory of registered animal drug establishments
and listed animal drug products and use the database to assess the availability
or anticipated shortage of animal drug products that would be needed to deal
with terrorist attacks;
- Develop analytical methods to detect the presence of prohibited animal
substances that could be introduced into U.S. animal feed supplies by bioterrorists.
Once developed and optimized, these methods would be used by FDA diagnostic
laboratories to test prohibited substances in routine animal feed surveys;
- Intensify the review of products offered for import and collaborate with
the U.S. Custom Service on safety and security issues at ports of entry;
- Increase the number of import line entries reviewed for admissibility into
domestic commerce;
- Strengthen relationships with state partners and solicit interest in the
expansion of contracting efforts with state laboratories to provide surveillance
and surge capacity related to counter terrorism activities; and,
- Sample domestic animal feeds and those detained at U.S. ports of entry that
contain ingredients possibly derived from contaminated animals.
SELECTED FY 2003 ACCOMPLISHMENTS
EFFICIENT RISK MANAGEMENT: THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY
BUCK
Bovine Spongiform Encephalopathy (BSE)
- As of September 23, 2003, inspected over 25,000 renderers, feed mills, and
other firms, including on-farm mixers and ruminant feeders, to determine compliance
with the BSE feed regulations. Re-inspections of the facilities determined
to be out of compliance with the BSE regulation are on going;
- Published a new Compliance Program entitled "BSE/Ruminant Feed Inspections"
to assist investigators in determining compliance with the FDA regulation
(21 CFR Part 589.2000) prohibiting the use of most animal proteins in ruminant
feeds; conducted five training sessions for investigators on the new compliance
program to enhance uniformity and quality of domestic inspections, and provided
updates on the science of BSE and animal protein detection methods; and, issued
a new import alert that called for the detention without physical examination
of animal feed products from BSE-at-risk countries that were analyzed as containing
animal protein material;
- Issued 7 Warning Letters for animal proteins prohibited in ruminant feed,
and 14 class II recalls at 12 firms in response to violations of the BSE rule;
- Created a new BSE web report which provides inspectional information derived
from the ORA-FACTS database involving all active FDA-inspected firms. This
web report allows for both dynamic, multi-field search and for a spreadsheet
download of all firm inspections;
- Organized the Animal Feed Safety Team comprised of representatives from
various FDA offices, as well as with two State Departments of Agriculture.
Approved and completed a charter, project definition and concept documents;
and,
- Held a two day meeting in September 2003, with industry, government and
public consumers, to discuss the potential development of a comprehensive,
risk-based Animal Feed Safety System. In addition, information was obtained
how animal feeds (individual ingredients and mixed feeds) should be manufactured
and distributed, to minimize risks to animals consuming the feed and humans
consuming food products from animals.
Premarket Review
- Decreased the backlog of overdue submissions in order to move FDA back on
track towards meeting statutory and stakeholder requirements for new animal
drug application reviews. FDA reduced its backlog by 101, from 278 to 177,
between October 1, 2002 and September 30, 2003. This reflects a 36.3 percent
reduction.
CVM Significant Approvals |
Type of Approvals |
FY 01 |
FY 02 |
FY 03 |
Totals |
39 |
59 |
64 |
Originals |
22 |
30 |
44 |
Supplementals |
16 |
28 |
19 |
Food Additive Petitions |
1 |
0 |
1 |
Public Master File |
0 |
1 |
0 |
Sample of Significant
Approval Types (Non-Add): |
|
|
|
New Chemical Entity |
2 |
4 |
4 |
New Indication |
2 |
8 |
4 |
New Species / Class |
6 |
8 |
8 |
New Minor Species |
1 |
1 |
0 |
ADAA |
7 |
16 |
2 |
In FY 2003, the Program experienced 8 percent increase in the number of significant
approvals of new animal drugs.
The number of approvals is expected to increase in the next several years as
FDA implements the newly enacted Animal Drug User Fee Act of 2003 that is intended
to improve the efficiency of the review of animal drugs and shorten the time
for new or improved therapies.
- Approved two noteworthy medicines.
- Neutersol provides a non-surgical (or chemical) castration for
young male dogs, which is the first FDA-approved alternative to surgical
castration. This will permit better control of pet over-population and give
shelter managers a positive way to address that problem by allowing a veterinarian
to administer the product to dogs on-site to ensure that adopted dogs are
sterilized. Previously, shelters relied on owners to take the adopted dogs
to a veterinarian for surgery for sterilization.
- Optaflexx is used for increasing the weight gain for cattle fed
in confinement prior to slaughter. This medicine will also improve feed
efficiency.
Biotechnology
- The Animal Biotechnology Working Group made progress on developing the science
basis for the regulation of animal biotechnology products and issued its first
annual report which details its efforts in coordinating reviews within and
outside of CVM on the safety of transgenic biopharmaceutical producing animals.
Transgenic biopharmaceutical producing animals include those animals that
contain heritable genes constructs that allow them to produce products for
pharmaceutical or industrial uses;
- Issued a Draft Executive Summary of "Animal Cloning: A Risk Assessment",
discussed publicly at the November meeting of FDA's Veterinary Medicine Advisory
Committee. The draft risk assessment, which evaluates the risks to animals
involved in the cloning process, is built on the findings of the National
Academy of Sciences which indicated that food products derived from animal
clones and their offspring are likely to be as safe to eat as food from their
non-clone counterparts; and,
- Conducted several investigational inquiries to researchers who may not be
aware of the need to obtain pre-market approval for their genetically engineered
products. FDA issued a reminder letter to all land-grant universities involved
in research dealing with genetic engineering that animal species commonly
used for food in research require an investigational new animal drug exemption
or another type of regulatory approval.
Imports, Inspections, and Surveillance
- Performed an inter-laboratory evaluation of a commercial chloramphenicol
screening test favored by state regulatory agencies. This Ridascreen test
was found to be acceptable for regulatory use. Chloramphenicol is an effective,
but toxic, antibiotic that is banned for use in all food producing animals.
The presence of any detectable level of chloramphenicol in food is forbidden
and foods so adulterated may not be imported for sale in the U.S.;
- Developed and validated sensitive and specific analytical procedures to
definitively identify the presence and quantity of nitrofuran metabolites
in shrimp. Like chloramphenicol, detectable levels of nitrofurans or their
metabolites in food are not allowed;
- Conducted a training course on the Residue Violation Information System
(RVIS), and the Tissue Residue Information Management System (TRIMS) for personnel
monitoring illegal drug residues in meat and poultry. RVIS is an interagency
database developed to enable the timely sharing of information on residue
violations. TRIMS, an FDA database linked to RVIS which contains results from
the Department of Agriculture's Food Safety and Inspection Service reported
residue violations. The objectives were: enable FDA District Program Monitors
to access RVIS; identify patterns of egregious violations; add inspectional
information, and provide management with violator reports; and,
- Created an outreach program to educate producers, veterinarians and students
about preventing drug residues in dairy animals; investigated 447 tissue residue
violations; and issued 65 tissue residue-related warning letters; 6 injunctions,
and 1 criminal action.
Emerging Issue -- Monkey-Pox
- Involved in the coordination and enforcement of the FDA/CDC Joint Order
on Monkey-Pox, a zoonotic disease that spread from imported African rodents
to prairie dogs to humans. The Joint Order was done under the Public Health
Service Act; and,
- Developed an approach to assure affected parties were notified of the Joint
Order, and coordinated the follow-up to possible violations of the Order;
stationed staff at CDC in Atlanta to work cooperatively on developing guidance
for this issue and evaluated requests for permits to allow movement of animals
for reasons other than those identified in the Joint Order, and drafted with
CDC the Interim Final Rule for Monkey-Pox that went on display November 3,
2003.
Interim Rule to Prevent Transmission of Monkeypox
To prevent the transmission of monkeypox, a rare viral disease, today
the Food and Drug Administration (FDA) and the Centers for Disease Control
and Prevention (CDC) issued an interim final rule to establish new restrictions
and modify existing restrictions on the import, capture, transport, sale,
barter, exchange, distribution and release of African rodents, North American
prairie dogs and certain other animals in the United States.
"This interim measure further enhances HHS's efforts to protect
the public health by preventing the spread of communicable diseases,"
said FDA Commissioner, Mark B. McClellan, M.D., PhD. "Today's actions
will minimize the likelihood of additional problems related to monkeypox."
Earlier this year, an outbreak of monkeypox linked to exotic animals
caused 37 confirmed, 12 probable, and 22 suspect cases in the United States.
Monkeypox is a communicable viral disease that occurs primarily in rain
forest regions of central and west Africa. Discovered in 1958 in Africa,
monkeypox was first reported in prairie dogs and humans in the United
State sin May 2003. |
IMPROVING PATIENT AND CONSUMER SAFETY
Antimicrobial Resistance
- Finalized and published Guidance for Industry #152 on antimicrobial resistance.
This guidance was developed with public input and is significant because it
provides a scientific, risk-based approach to preventing antimicrobial resistance
that may result from the use of antimicrobial drugs in food-producing animals;
- Continued to review previously approved new animal antimicrobial drug submissions
with respect to antimicrobial resistance and human food safety; and,
- Completed the Abattoir (slaughterhouse) survey wherein bacterial samples
were obtained from abattoir workers handling live chickens and compared them
to bacterial samples from a human control group. The purpose of the study
was to examine the extent to which human antibiotic resistance may be transferred
to humans from the food and animal production environment. The abattoir study
results showed that the prevalence of Campylobacter was higher among abattoir
(slaughterhouse) poultry workers (48 percent positive) than among the general
population (14 percent positive) living in the same general geographical area.
The findings would suggest that poultry workers may be at higher risk for
exposure to foodborne pathogens, in this case from the poultry production
environment, than the general population.
Guidance on Evaluating the Safety of Antimicrobial
New Animal Drugs
The FDA issued a guidance document (Guidance for Industry #152 ("Evaluating
the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological
Effects on Bacteria of Human Health Concern") that for the first time
outlines a comprehensive evidence-based approach to preventing antimicrobial
resistance that may result from the use of antimicrobial drugs in animals.
Antimicrobial drugs, such as antibiotics, are medicines often used to
treat bacterial infections in both humans and animals. Their use has been
one of the great advances in modern medicine -- helping to prevent many
of the leading causes of death for most of human history.
When bacteria develop resistance, human and animal health is at risk
because the medicines that we depend on to treat infections become ineffective.
There are several important sources of this problem, including inappropriate
use of antibiotics in people, but the new FDA guidance addresses the issue
of the use of antimicrobials in food producing animals as a contributing
factor to the development of antimicrobial resistance.
The guidance provides a scientific process for assessing the likelihood
that an antimicrobial drug used to treat an animal may cause an antimicrobial
resistance problem in humans consuming meat or other byproducts from that
animal. This process can help prevent antimicrobial drugs with a high
risk of causing such problems from being improperly used in food producing
animals, and thereby potentially leading to antimicrobial resistance in
humans. The guidance is directed at animal drug sponsors who seek FDA
approval of an antimicrobial for use in food-producing animals. More information
is available online at ww.fda.gov/oc/antimicrobial/questions.html. |
National Antimicrobial Resistance Monitoring System (NARMS)
- Completed a study as a part of the NARMS to collect data on the prevalence
and antimicrobial drug susceptibility of foodborne bacteria in retail meat.
The research findings were:
- Campylobacter was recovered from chicken more often than the
other three meat types;
- Salmonella was recovered from turkey more often than the other
three meat types;
- Enterococci were recovered from all meats at similar contamination
rates (all above 96 percent);
- No Salmonella were isolated from any pork and no Campylobacter
were isolated from ground beef; and,
- The results of this ongoing study demonstrate that Campylobacter
and Salmonella are present in a significant percentage of retail
poultry, including antibiotic resistant variant.
- Provided an intensive training course on methods to ensure that the FoodNet
sites located in nine states follow standardized protocols to ensure the success
of the NARMS retail food program. Nine states currently participate in monthly
grocery store sampling of various types of meat to culture for the presence
of Salmonella and Campylobacter. In addition, four sites (Georgia,
Maryland, Oregon, and Tennessee) culture the rinse for E. coli and
enterococci;
- Added the retail food component of NARMS which provides a more representative
picture of the contribution of the food supply to antimicrobial resistance
among enteric bacteria of animal origin, and continued sharing information
with the other agencies since the three arms of NARMS (human, animal and retail
meat) are integral components of the monitoring system. FDA is able to track
the changes in susceptibility among isolates from all three sources;
- Supplied data to PulseNet, a national computer network of DNA fingerprinting
database for foodborne pathogens, and worked in conjunction with the NARMS/FoodNet
retail food surveillance, in determining the genetic relatedness of all Salmonella
and Campylobacter isolated from the FoodNet sites; and,
- Completed the second year of a three-year cooperative agreement with Mexico
to determine the prevalence of Salmonella, Campylobacter, and quinolone-resistance
generic E. coli in humans, chicken, cattle, and pigs on farms, and
the identification and comparison of the susceptibility profiles of the Salmonella,
Campylobacter, and E. coli isolates. The agreement has also:
- Fostered collaboration among Mexican and U.S. microbiologists and epidemiologists.
As a result, the Mexican national capacity in the surveillance of foodborne
disease and resistant pathogens has been strengthened; and,
- Recognized FDA's efforts by being awarded the HHS Secretary's Award
for Distinguished Service.
FDA Conducts Retail Meat Pilot Study
Retail foods such as raw meat may be contaminated with resistant organisms.
FDA conducted a pilot study as a part of the NARMS to collect data on
the prevalence and antimicrobial drug susceptibility of foodborne bacteria
in retail meat; develop laboratory methods for the testing of retail meat
products; and, determine the feasibility of conducting on-going surveillance
of retail meats. A random sample of 300 of approximately 500 retail groceries
located in Iowa was selected with a total of 981 samples from 263 groceries
were collected as part of the Iowa Pilot Study and more than 2,000 bacterial
isolates were tested at FDA. The results from this study will generate
prevalence and antimicrobial drug susceptibility data on foodborne organisms
such as Salmonella, Campylobacter, and Enterococcus spp. The study will
also help quantify the role contaminated food plays in spreading antibiotic
resistant bacteria. |
PROTECTING AMERICA FROM TERRORISM
Counterterrorism
- Participated in the May Top Officials 2 (TOPOFF) exercise and assisted the
Agency in identifying information and coordinating responses relating to animal
drug and feed issues with participants from other government agencies and
industries. During the TOPOFF 2 exercise, CVM coordinated an "outside
of the box" component leading to the prevention of continued zoonotic
spread of the plague involving owners and their pets;
- Worked with the Department of Energy and Iowa State University on a database
to describe test method capabilities of veterinary diagnostic laboratories;
- Intensified the review of products offered for import, and collaborated
with the Department of Homeland Security's Customs and Border Protection at
ports on safety and security issues. FDA also played an active role in providing
information about how to take, preserve, and ship an appropriate feed or animal
sample to laboratory for analysis; and,
- Drafted preliminary assessment of vulnerabilities in the feed industry,
and is working to update its Counterterrorism Plan on emergency preparedness
and response, including scenarios where animal feeds may be a vector. Additionally,
interagency mock exercises on response to BSE introduction to the U.S. are
taking place.
STRONG FDA
Under this strategic goal, the Animal Drugs and Feeds Program supports the
Agency efforts to strengthen its infrastructure, enhance employee performance,
and take other steps to build a high functioning organization. Some of the accomplishments
achieved in CVM include:
- Improved financial management -- CVM continues the implementation of activity-based
costing (ABC) practices that directly support the FDA Strategic Plan and CVM's
"Back to Basics" approach. The ABC process clearly communicates
the Program's priorities to the front line staff and emphasizes what is important
for staff to spend time on. Included in the "Back to Basics" strategy
are the development of a five year business plan and a project management
tracking system;
- Strategic management of human capital -- CVM developed and implemented strategy
to integrate its staff college competency model with the recruiting and interviewing
process to ensure selection of best candidates by using the Lominger Recruitment
Architect, a tool for identifying the best qualified candidates, by providing
targeted interview questions that screen for technical skills, leadership,
management and team skills, and learning agility. CVM's Staff College was
recognized as having the best practice government-wide for its Competency
Model and Learning Management System;
- Competitive sourcing --CVM conducted meetings for all staff to explain the
competitive sourcing process and administrative consolidation efforts; and,
- Integration of Budget and Performance -- CVM developed a Center Strategic
Plan that supports and nests within the FDA Strategic Plan. The major theme
of the CVM plan is "Getting Back to Basics" that involves re-engineering
many of program's business processes and developing new ways to measure and
improve program performance on the Program's core mission and functions. Over
140 individual project plans have been developed, approved and are being monitored
for progress by the Center's Strategic Plan working group.
Animal Drugs and Feeds Program Activity Data
Program Workload and Output 1 |
FY 2003
Actuals |
FY 2004
Estimate |
FY 2005
Estimate |
New Animal Drug Applications (NADAs):2 |
|
|
|
Received |
28 |
25 |
25 |
Completed |
29 |
25 |
25 |
Approved |
18 |
19 |
19 |
Pending 3 |
11 |
11 |
11 |
NADAs
- review & act on 90% w/in 1 |
|
295 days |
270 days |
New Animal Drug Application Supplements:2 4 |
|
|
|
Received |
568 |
596 |
626 |
Completed |
570 |
598 |
628 |
Approved |
439 |
457 |
475 |
Pending 3 |
225 |
223 |
221 |
Safety & Efficacy -- review & act on 90% w/in
1 |
|
320 days |
285 days |
Manufacturing -- review &
act on 90% w/in 1 |
|
225 days |
190 days |
Abbreviated New Animal Drug Applications: 2 |
|
|
|
Received |
49 |
49 |
49 |
Completed |
54 |
54 |
54 |
Approved |
26 |
26 |
26 |
Pending 3 |
41 |
36 |
31 |
Abbreviated New Animal Drug Application Supplements::2 4
|
|
|
|
Received |
143 |
150 |
158 |
Completed |
128 |
135 |
142 |
Approved |
87 |
92 |
97 |
Pending 3 |
61 |
76 |
92 |
Investigational New Animal Drug (INAD) Files:5 |
|
|
|
Received |
2,175 |
2,200 |
2,200 |
Completed |
2,521 |
2,200 |
2,200 |
Pending 3 |
293 |
293 |
293 |
Protocols
-- review & act on 90% w/in 1 |
|
125 days |
100 days |
1 CVM
is transitioning to user fee goals (reference CVM budget justification
and performance plan). A sample of the enhanced performance under the
ADUFA program is reflected by the improved timeliness (number of days).
At this time, it is not possible to anticipate a large increase in submissions
from industry. Also, FY 2003-2005 figures do not include invited labeling
change supplemental applications because it is not possible to accurately
project sponsor or CVM requests for this type of application.
2 Includes originals and reactivations. If the application
is not approvable, the sponsor may submit additional information until
the Agency is able to approve the application.
3 Reflects submissions (received during the fiscal year) which
still require review.
4 A supplemental application is a sponsor request to change
the conditions of the existing approval. They can be significant (a new
species or indication), or routine (product manufacturing changes).
5 An INAD or JINAD file is established at the request of the
sponsor to archive all sponsor submissions for a phased drug review including:
request for interstate shipment of an unapproved drug for study, protocols,
technical sections, data sets, meeting requests, memos of conference and
other information.
|
Animal Drugs and Feeds Program Activity Data
Program Workload and Output |
FY 2003
Actuals |
FY 2004
Estimate |
FY 2005
Estimate |
Investigational New Animal Drug (INAD) Files: (contd) |
|
|
|
Data --review & act on 90% w/in 1 |
|
320 days |
285 days |
Generic Investigational New Animal Drug (JINAD) Files: |
|
|
|
Received |
132 |
100 |
100 |
Completed |
235 |
108 |
108 |
Pending |
26 |
18 |
10 |
Investigational Food Additive Petitions |
42 |
40 |
40 |
Food (Animal) Additive Petitions 6 2 |
28 |
30 |
30 |
Production & Manufacturing Defect Reports - Received
- Reviewed
|
2,075
1,775 |
2,000
1,900 |
2,000
1,900 |
Adverse Experience Reports (AERs) - Received
- Reviewed |
23,079
19,483 |
25,000
23,600 |
25,000
23,600 |
Animal/Medicated Feed Partnership Agreements |
25 |
30 |
30 |
NARMS Salmonella Isolates Tested - 03 data not available yet* |
* |
12,000 |
12,000 |
PROGRAM OUTPUTS-DOMESTIC INSPECTIONS7 |
|
|
|
Preapproval/Bioresearch Monitoring Programs Inspections |
102 |
190 |
190 |
Drug Process and New ADF Programs Inspections |
255 |
260 |
260 |
BSE Inspections |
2,598 |
2,800 |
3,720 |
Feed Contaminant Inspections |
57 |
100 |
100 |
Illegal Tissue Residue Program Inspections |
324 |
364 |
364 |
Feed Manufacturing Program Inspections |
457 |
300 |
300 |
State Contract Inspections: BSE |
3,119 |
3,100 |
5,600 |
State Contract Inspections: Feed Manufacturers |
412 |
360 |
360 |
State Contract Inspections: Illegal Tissue Residue |
407 |
670 |
670 |
State Partnership Inspections: BSE & Other |
700 |
700 |
700 |
Total FDA & State Contract Inspections |
8,431 |
8,844 |
12,264 |
State Contract Animal Drugs/Feeds Funding |
$1,650,000 |
$1,980,000 |
$5,000,000 |
Domestic Laboratory Samples Analyzed 8 |
1,374 |
2,400 |
2,400 |
PROGRAM OUTPUTS-IMPORT/FOREIGN INSPECTIONS |
|
|
|
Foreign Preapproval/Bio Monitoring Programs Inspections |
30 |
50 |
50 |
Foreign Drug Process and New ADF Program Inspections |
16 |
10 |
10 |
Total FDA Foreign Inspections |
46 |
60 |
60 |
6 Non-drug
substances added to animal feed are considered Food Additive Petitions
and require review and approval.
7 An Inspection is any visit to a firm during which all or
part of one or more phases of that establishment's operation is evaluated
against appropriate Agency requirements.
|
Animal Drugs and Feeds Program Activity Data
Program Workload and Output |
FY 2003
Actuals |
FY 2004
Estimate |
FY 2005
Estimate |
Import Field Exams/Tests9 |
3,261 |
500 |
500 |
Import Laboratory Samples Analyzed8 |
388 |
775 |
775 |
Import Physical Exam (Subtotal) |
3,649 |
1,275 |
1,275 |
Import Lines |
146,360 |
173,000 |
204,000 |
Percent --Physical Exams of Import Lines |
2.5% |
0.74% |
0.63% |
8 Laboratory
Samples Analyzed are product samples physically analyzed in the laboratory
to determine whether or not the product is in compliance with Agency requirements.
9 A Field Exam is the on-site examination of a product that
is sufficient in itself to determine whether the product is in compliance
with Agency requirements. |