Securing Drugs Unavailable in the U.S.
1. Introduction
2. Locating a Supplier
3. Unlicensed Drugs
4. Importing Drugs into the U.S.
5. Securing FDA Permission
1. Introduction
Drugs that you may wish to give your cat can be unavailable to you for several reasons:
● Because your vet cannot locate a supplier of the drug.
● Because the drug is unlicensed for use in animals.
● Because the drug has not been FDA approved and so is not marketed in the U.S.
Here is how, in each case, you can take steps to deal with the problem:.
2. Locating a Supplier
This one is easy. Do the legwork yourself. It’s called the Internet. Feed the drug to search
engines. Feed the disease (e.g., FIV) or the disease and the drug together to search engines and
look for leads. Join forums devoted to feline diseases for which the drug has been or might be
used and post queries. (Search engines index many forum postings, as well.) Your vet could
probably track down a source if he had unlimited time and inclination, but he doesn’t. Most vets,
for instance, would be clueless about locating many HIV antiviral drugs. If you find potential
suppliers, you can pass the information on to your vet and have him make contact, but, frankly,
you are likely to do better by making first contact yourself, establishing that the drug is available
or finding out what is necessary to make it available. Who is likely to be more dogged, you or
your vet? Get the maximum amount of information available to a layperson, then pass it on to
your vet.
3. Unlicensed Drugs
“Unlicensed Drug” has a more desperate sound to it than reality bears out. Lots of drugs
commonly given by vets to cats are not licensed by the FDA for use in cats in the U.S. because
the procedure for securing approval is too expensive. The FDA permits veterinarians to use
unlicensed drugs if the they assume responsibility for the clinical judgment involved in selecting
the drug, have first-hand knowledge of the animal and the clinical situation which the drug is
addressing, and are available for debriefing in the event of an adverse reaction.
What this means is that your vet’s willingness to go out on a limb to accommodate your wishes
and your cat’s needs is by far the single most important factor in securing and using unlicensed
drugs. If you have reason to think that willingness may not be forthcoming, do your homework.
When I decided I wanted to give my cat a cocktail of human antiretroviral drugs unlicensed for
use in cats I did my homework, wrote up the research as a formal proposal, and presented it to
my vet, complete with supporting documentation. It was convincing, but if my vet hadn’t been
convinced, I would have gone elsewhere if I had reason to think that there was another vet who
might be more supportive.
4. Importing Drugs into the U.S.
Some drugs of potential benefit to FIV+ cats simply are not available in the U.S. Feline Omega
Interferon, for instance, is licensed for use as an FIV therapy in many countries; it is not licensed
for any purpose in the U.S. and is not available for clinical use. Ketotifen, an antiinflammatory
and weak immunomodulator of potential use in treating primary and secondary FIV-related
problems, is a commonly used human (not veterinary) drug in many countries, but is totally
unavailable in the U.S. If you live in the U.S. and decide you want to use such a drug, you will
have to import it. To do so you will have either to secure FDA approval to import it or find a
supplier willing to export it to the U.S. without FDA approval and, in some cases at least (for
instance omega interferon), a veterinarian willing to prescribe and receive it without FDA
approval. If the existence of such vets sounds improbable . . . think again. The FDA’s craven
stand on thalidomide, a drug of inestimable value to FIV+ cats suffering from refractory
stomatitis ( a cruel and painful disease), evidently did not discourage all vets from importing the
drug from abroad. Thalidomide is unavailable in the U.S. for veterinary use under any
circumstances and a bit of lawyer-think exactly suggests the reason why. The FDA pointedly
issued a directive forbidding import, the only explanation for which is that it was being done.
So one of the decisions a cat owner may need to make is whether to try, perhaps fruitlessly and
time-consumingly, to secure FDA approval for import if the drug is obtainable without that
approval. This is not a decision to be made lightly. There may be legitimate concerns about
safety and effectiveness behind a lack of FDA approval. (There may also be bureaucratic inertia
behind lack of approval. And it is important to realize that many makers of effective drugs and
supplement choose not to seek FDA approval, particularly if the market is limited, because of the
expense involved in satisfying FDA standards.) Importing without FDA approval could be
costly (if the drug is confiscated or is uninsurable in case of spoilage) or could leave a bogus
product in the unknowing hands of the person who ordered it. On the other hand, if one has
made the decision that this is a drug his cat needs to have, well . . . finish the sentence yourself.
Securing FDA approval can be a cumbersome and time-consuming process. If one wishes to do
so, however, here is the standard procedure.
5. Securing FDA Permission
Have your vet submit or fax a letter to:
Division of Compliance
Center for Veterinary Food and Drug Administration
Metro Park North
7500 Standish Place
Rockville, Maryland 20855
Phone: (301) 594-0796
Fax: (301) 827-1498
The letter should contain the following information:
1) The client’s name and address
2) Your (the veterinarian’s) name, the veterinary facility’s name, address, and phone number
3) The patient’s name and species
4) The name of the drug
5) The drug class or family
6) The name and address of the drug supplier
7) The legal status of the drug in the country from which it is being imported
8) The amount of the drug to be imported–must be a small, noncommercial quantity
9) The disease or condition to be treated
10) The reason why an approved human or animal drug will not treat this disease or condition.
11) A statement (a) that you (the veterinarian) will notify the animal owner the drug is not
approved; (b) that the drug will not be used in any food animal; (c) and that you agree to notify
the FDA if there are adverse reactions.
12) How you learned of the existence of the drug. (If there is any suggestion that the product has
been actively promoted in U.S. markets, it will be refused entry and an import alert will be
issued.)
Notes:
● Be sure that you have a known supplier before seeking approval. Do not try to seek
provisional approval contingent on later naming a supplier. It is pointless to seek
approval without one, and any attempt to change supplier will cause significant delays in
approval.
● When you get an approval letter, let your importer decide the best way of getting the
drugs to you and what to do with your letter of approval. People have been known to
follow the FDA’s procedure only to have perishable drugs flagged anyway at Customs
and held past their perishability date.
● Expect delays and aggravation. This is the U.S. government.
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