August 29, 2012 presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Review Course, with a focus on: * new animal drug applications * generic new animal drugs applications * species and uses

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Veterinary Medicine
SDRAN RAC Exam Review Course
Wednesday, August 29, 2012
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice

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Standard Disclaimers
• Views expressed here are solely mine and do not
reflect those of my firm or any of its clients.
• This presentation supports an oral briefing and
should not be relied upon solely on its own to
support any conclusion of law or fact.
• These slides are intended to provide general
educational information and are not intended to
convey legal advice.
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Basics
• Center for Veterinary Medicine (CVM) – controls:
– New Animal Drug Application (NADA) process
 Investigational
 Full
 Abbreviated
– Medicated Feeds
– Pet Food
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Investigational New Animal Drug (INAD)
• Must be in place before shipping an investigational
new animal drug
• Reviewed by Office of New Animal Drug
Evaluation (ONADE)
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New Animal Drug Application (NADA)
• New animal drug – Section 201(v) of the Act:
… means any drug intended for use for animals other than man, including any drug
intended for use in animal feed but not including such animal feed,—
(1) the composition of which is such that such drug is not generally recognized, among
experts qualified by scientific training and experience to evaluate the safety and
effectiveness of animal drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling thereof; except that such a drug not so
recognized shall not be deemed to be a ―new animal drug‖ if at any time prior to June 25,
1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such
time its labeling contained the same representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such conditions, has become so
recognized but which has not, otherwise than in such investigations, been used to a
material extent or for a material time under such conditions
• Safety – in target animal and humans that might
consume same animal5

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NADA …
 Identification
 Table of Contents
 Labeling
 Components & Composition
 Manufacturing Methods,
Facilities & Controls
 Samples
 Analytical Methods for
Residues
 Safety & Effectiveness
Evidence
 Applicant’s commitment to
market consistent with NADA
 GMP Compliance
 GLP Compliance
 Environmental Assessment
(unless Categorical Exclusion
applies)
 FOI Summary – of studies
serving as basis for approval –
FDA will release to public
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● Governed by Section 512(b) of Act and 21 CFR 514
● Basic sections:

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NADA -- Requirements & Processes
• Patent information – holder of approved NADA
must ―list‖ with FDA if claims drug or a method of
use for drug
• FDA must publicize approvals monthly – ―Green
Book‖
• Phased submission/review – allowed by CVM –
leads to a ―technical section complete‖ letter
– Administrative NADA – CVM then has 180 days
• Expedited Review – ERS – advances in animal
health or reduction of human pathogens
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MUMS – Minor Use/Minor Species
• Major species – horse, cattle, dog, cat, pigs,
chickens, and turkeys
• Minor species – all others
• Minor use -- major species for indication that occurs
infrequently and in only a small number of animals
or in limited geographical areas and in only a small
number of animals annually.
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MUMS – Benefits and Procedures
• ―Conditional Approval‖ – can market after proving
safe if reasonable expectation of effectiveness
– have 5 years to collect effectiveness data via annual renewals
• ―Indexing‖ – 21 CFR 516 – legally marketed drugs
can be used for unapproved minor species
– reviewed by expert panels
• Designation – if received, can get 7 years market
exclusivity and other monetary benefits
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Generics – Abbreviated NADA (ANADA)
• 1988 – created by Generic Animal Drug and Patent
Term Restoration Act (GADPTRA) – very similar to
Waxman-Hatch Act for human drugs
– Bioequivalence – in at least one labeled species
• Market exclusivity available for full NADAs
– 5 years – New Chemical Entity
– 3 years – New studies –
 substantial evidence of the effectiveness of the drug involved, any studies of
animal safety, or, in the case of food producing animals, human food safety
studies (other than bioequivalence studies or residue depletion studies, except
residue depletion studies for minor uses or minor species) required for the
approval of the application and conducted or sponsored by the applicant
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Animal Drug User Fee Act (ADUFA)
• Initially put in place in 2003; thus, not on same
reauthorization schedule as other user fees
• Waivers or reductions – may be possible:
– application submitted under MUMS – Minor Use/Minor
Species solely for a MU or MS
– small business
– NADA solely to provide for AD’s use in a “free-choice
medicated feed”
• Technically, do not apply to Abbreviated New
Animal Drug Applications, but they have a separate
law -- AGDUFA11

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Animal Feeds
• Non-medicated – to meet animal’s nutritional needs
– includes pet food
– generally – no prior approval by CVM if made from approved
food additives or GRAS (generally recognized as safe) ingredients
• Medicated – to deliver drug to animal
• Dietary supplements marketed for animals – treated
as food and not under DSHEA
• Three types:
– Type A Medicated Articles
– Type B Medicated Feeds
– Type C Medicated Feeds
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Type A Medicated Articles
• Mixtures of one or more drug substance(s) with
appropriate vehicles
• Requires pre-approval of an NADA or ANADA
• Category I – require no withdrawal period at lowest
use level in each species in which approved
• Category II – require a withdrawal at lowest use
level in at least one species or regulated on a ―no
residue‖ basis or with a zero tolerance
• Intended solely to manufacture another Type A or a
Type B or Type C Medicated Feed
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Type B Medicated Feed
• Contains either a Type A Medicated Article or
another Type B Medicated Feed, plus substantial
quantity of nutrients (at least 25% of total weight)
• Used solely to manufacture another Type B
Medicated Feed or a Type C
• Before being fed to animal, must be substantially
diluted to produce a Type C Medicated Feed
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Type C Medicated Feed
• Contains an active drug component – intended:
– as complete animal feed; or
– to be fed top-dressed; or
– offered free choice in conjunction with other animal feed to
supplement the animal’s total daily ration
• Produced by substantially diluting a Type A
Medicated Feed, a Type B Medicated Feed, or
another Type C Medicated Feed
• Medicated Feed cGMPs – 21 CFR 225
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Off-Label Use
• Animal Medicinal Drug Use Clarification Act of 1994
(AMDUCA)
– Allows for veterinarians to use approved animal drugs for
unapproved uses
 can’t result in violative residues in food-producing animals
 consistent with regulations in 21 CFR 530
– Allows for use of approved human drugs for animal uses under
certain circumstances
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Veterinary Devices
• CVM has jurisdiction, but not significantly regulated
– Adequate directions for use in target species
– Subject to adulteration and misbranding provisions of Act
– QSR for human devices not applicable
– Must meet other requirements such as laser standards
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Veterinary Biologics
• Regulated by Center for Veterinary Biologics in
Animal & Plant Health Inspection Service (APHIS)
at USDA
• Under Virus-Serum Toxin Act (VSTA) of 1913
– Pure, safe, potent and effective biologics
– Veterinary Biologics Establishment License
– Veterinary Biologics Product License
– Allows for a phased review of license applications
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Questions?
• Call, e-mail or fax:
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, California 92101
direct: 619-744-2215
fax: 619-923-6248
maswit@duanemorris.com
• Follow me on:
– LinkedIn: http://www.linkedin.com/in/michaelswit
– Twitter: https://twitter.com/FDACounsel
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About Your Speaker
Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm,
Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by
highly-regulated pharmaceutical and medical device companies. Before joining Duane Morris in
March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a
preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes
product development, compliance and enforcement, recalls and crisis management, submissions
and related traditional FDA regulatory activities, labeling and advertising, and clinical research
efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and
therapeutic biotech products. Mr. Swit has been addressing vital FDA legal and regulatory issues
since 1984, both in private practice with McKenna & Cuneo and Heller Ehrman, and as vice
president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty
drug firm. He also was, from 1994 to 1998, CEO of FDANews.com, a premier publisher of
regulatory newsletters and other specialty information products for FDA-regulated firms. He has
taught and written on many topics relating to FDA regulation and associated commercial
activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his
A.B., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at
Emory University.
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