Unapproved Animal Drugs Unapproved Animal Drugs

Unapproved Animal Drugs
FDA Request for Comment

What are unapproved drugs
• Any product labeled or intended for use in the
diagnosis, cure, mitigation, treatment, or prevention
of disease in animals or that affects the structure or
function of the body that is not the subject of a new
animal drug application.
• Any drug that is not a new drug because it is
generally recognized as safe and effective and
therefore does not need to be approved.
• FDA states in the notice that for all practical purposes
unapproved drugs are considered new animal drugs.

Unapproved Drugs
• Longstanding gproblem – many are not classical
pharmaceuticals—virtually all are over the counter with
some exceptions.
• Human drugs are primarily approved as prescription
products or when there is a switch from RX to OTC.
• Most OTC drugs are GRAS/GRAE under monographs
outlining acceptable claims and doses—cough and cold
remedies, topical skin care are some examples.
• CVM approves both OTC and RX new animal drugs‐ there
is no monograph system‐one of the options suggested in
the notice.

Why have these products not been
approved
• Too costly to try and get an approval based on
market return.
• Sponsors don’t consider them to be drugs. No
specific label claim for treating a disease‐ palliative or
supportive therapy.
• Low priority for CVM concern ‐ few if any consumer
complaints about safety or lack of efficacy.
• Can’t really prove they are effective through
controlled efficacy studies.

Types of Unapproved Products
• FDA notice:
– Injectable vitamins
– various topical solutions
– shampoos
– liniments
– electrolyte and glucose solutions
– Antidotes
– Anti‐infectives infectives (teat dips)
• No mention of pharmacy compounding but is major AHI
concern.

AHI Comments
• We agree with the goal of CVM to try and increase
the number of approved or legally marketed animal
drugs.
• Existing pathway under 21 CFR 514.1 for submission
and approval of a New Animal Drug Application.
• Legalizing the marketing of new animal drugs outside
of this regulation may not assure the safety, efficacy
and quality demanded d dfor approved animal drugs.

Need to preserve products needed by
veterinarians
• Some unapproved drugs are serving a therapeutic
need that is not met by an approved drug.
• Specific compounds that meet a defined
physiological need where there is a clear
deficiency.
• CVM needs to be careful in how they exercise their
authority over some of drugs which are important
to veterinary medicine.

CVM should prioritize drugs of highest
concern
• Drug products with valid scientific basis for
effectiveness
• Those drug products that may present animal or
food safety concern
• Drug products labeled for indications that are in
competition with FDA approved animal drugs
• Drug products containing active ingredients that
have been illegally compounded.

AHI Concerns
• AHI members do not see most types of unapproved
products identified by CVM as competing with
approved animal drugs.
• AHI is very disturbed d about tthe widespread
d
proliferation of compounding pharmacies promoting
and selling numerous unapproved new animal drugs in
clear violation of the FD&C Act.
• AHI strongly opposes any policy which would legalize
compounded medications outside of the strict
provisions of the Animal Medicinal Drug Use
Clarification Act (AMDUCA).

Summary
• In summary we have more questions than answers to
the notice.
• Difficult to determine the impact on livestock
industry until FDA identifies products of concern.
• Due to food safety hard to imagine many food animal
products escaping requirement for approval as a new
animal drug‐may be some exceptions for topical
products.
• Main impact would seem to be on equine and
companion animal drugs.

Summary
• We appreciate the desire by the agency to level
the playing field.
• The question is how creative CVM is willing to go
in legalizing these products short of a full blown
NADA approval
• Should not be a double standard for marketing
products except for clear and scientifically
justified exceptions.