FDA Approved Drugs vs. Medical Devices, Compounded Drugs and Supplements/Nutraceuticals
There are many products marketed for treatment of equine degenerative joint disease.
The different products available include FDA approved pharmaceuticals, veterinary medical devices, compounded drugs, and supplements/nutraceuticals. So, how can you evaluate these options?
Here is some important information that should help you form your own opinion.
FACTS about FDA approved drugs
FDA Pioneer Drug:
FDA Approved Generic Drug:
A generic drug is bioequivalent to a brand-name drug in dosage form, efficacy, safety, strength, route of administration, quality
and intended use. True generic drugs are chemical copies of brand-name drugs that are no longer patent protected. Generic drug labels
display an ANADA number or ANDA number signifying FDA approval of the generic animal drug or human drug, respectively. Generic drugs and their
active ingredients also must be manufactured under GMP in federally inspected plants.1
FDA Approved Drugs Are Subject to the Following Standards:
- A drug that has been rigorously tested by undergoing blinded and controlled clinical studies to investigate its safety and efficacy and in
accordance with FDA mandated standards and regulations such as Good Clinical Practices (GCPs)
- The active ingredient and product were manufactured under FDA mandated Good Manufacturing Practices (GMPs) in regularly inspected plants
- Therapeutic consistency, product quality, accurate drug shelf life, and scientifically substantiated labeling are all FDA mandated for these products
- Stringent testing standards for drug potency and purity must be established and stability data generated in order to determine expiration dating
- Detailed records of each batch of drug produced must be maintained and representative samples of each batch of drug retained for future testing
- Continual monitoring for adverse events, safety, and efficacy is conducted by the manufacturer and must be regularly reported to the FDA
How can YOU tell if a product is FDA Approved?
Many veterinary products may appear to be similar to pharmaceuticals. However, ONLY FDA approved pharmaceuticals are given a 6 digit New
Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA for generics) number. Look on the products label or outer
box to ensure that the product is FDA approved. The location of the NADA number for BetaVet® is located toward the bottom of the outer box;
for Adequan® the NADA number is located on the bottom of the vial label.1
You can also visit www.fda.gov for more information on approved drugs.
- Drug Efficacy in at least two well-controlled trials one of which must be in clinical cases
- Drug Safety in one or more studies in the target species
- All active ingredients for drug manufacture must be obtained from an FDA registered and inspected source
- A manufacturing procedure that meets the rigorous standards of the Good Manufacturing Practices (GMP) overseen by FDA
- Stringent testing for drug potency and purity must be established
- Stability data generated in order to establish the expiration dating
- Detailed records of each batch of drug produced must be maintained
- FDA regularly inspects manufacturing facilities
- Continual monitoring for adverse events, safety and efficacy
Adequan® (polysulfated glycosaminoglycan) is the ONLY product in its class approved by the FDA for the intramuscular treatment
of non-infectious degenerative and/or traumatic joint dysfunction of the carpal and hock joints in horses.
BetaVet® (betamethasone sodium phosphate & betamethasone acetate) is the only dual ingredient injectable
corticosteroid approved by the FDA for use in horses.
FACTS about veterinary medical devices:
FACTS about compounded drugs:
A medical device as defined by the Food and Drug Administration in the Food Drug and Cosmetic Act, Section 210(h):
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part,
or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease,
in man or other animals, or intended to affect the structure or any function of the body of man or animals and which does not achieve any of its principal
intended purposes through chemical action within or on the body of man or other animals and is not dependent upon being metabolized for the achievement of
any of its principal intended purposes.”2
Needles, syringes, prosthetic devices, x-ray equipment, MRI unit, pacemakers, stents, surgical lasers, shock-wave unit, and barriers in the form of sheets or solutions, etc.
It should always be preferable to use FDA-approved products over options which are not required to demonstrate safety or efficacy, are not routinely monitored and are not regulated with the same level of scrutiny.
FACTS about supplements/nutraceuticals:
A Compounded Drug is any drug manipulated to produce a new dosage form drug.
Compounded products are:
Legal compounding requires a valid veterinarian-client-patient relationship (VCPR). Use of compounded drugs
should be limited to unique needs in specific animals and to those uses for which a response to therapy can be monitored,
or those for which no other method or route of drug delivery is practical or available. It is illegal to compound a
specific product when there is an approved drug form of that product except to make a different dosing form. However,
the approved product must be used to make the compounded new dose form. Bulk compounding and sales is illegal.
The prescribing veterinarian and owner should remember that compounded drugs are not subject to the FDA approval
process for testing for safety, efficacy, stability, potency and consistency of manufacturing. Consistency from
one batch to another, amount of the stated drug substance, and safety and efficacy for the intended use cannot be ensured.1
Compounded Drug Considerations:
- NOT FDA APPROVED
- NOT GENERIC DRUGS
- No regulations on raw material sources
- No quality standards batch to batch
- No requisite stability data
- Illegal to put expiration dating beyond 180 days
- Compounding pharmacies are not required to carry liability insurance
- No required monitoring for safety, efficacy, ADEs
- The prescribing veterinarian is responsible for safety and efficacy monitoring1
Available product comparison summary
Oral joint supplements are loosely classified as nutraceuticals. The term “nutraceutical” combines the word “nutrient”
(nourishing food or food component) with “pharmaceutical” (a medical drug) and describes a broad list of products sold under the premise
of being a dietary supplement (i.e., a food) but for the expressed intent of treatment or prevention of disease. The variety of claims to
aid in equine joint health are often unsupported. The potential difference between a feed and a nutraceutical is that a nutraceutical is
unlikely to have an established nutritive value. Feeds are required to have nutritive value and are accountable, by labeling, for
these values. Joint supplements fall in between food and drug and have marketing advantages over both because they are not required
to list ingredients or nutrient profiles as required by feeds, and in many cases are intended to treat or prevent disease without
first undergoing proper drug approval.3
- Supplements/nutraceuticals are not regulated by the FDA to the same extent
- No direct oversight regarding disease treatment or prevention claims
- No pre-market approval process
- No requirement for monitoring of safety or efficacy
As always, when you encounter different products in the marketplace, we encourage you to seek
the advice of your veterinarian and discuss the importance of FDA approved treatment options. It should always
be preferable to use FDA-approved products over other products available in the equine marketplace which are
not required to demonstrate safety or efficacy, are not routinely monitored, and are not regulated with
the same level of scrutiny.
*There have not been any published head to head comparisons with regard to superiority/efficacy.
Product Comparison Chart4, 5, 6