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About Michael Anisfeld
Expertise
Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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Past/Present Clients
UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries

You are here: Experts > Health/Fitness > Pharmacology > Pharmaceuticals > Off-label prescriptions

Pharmaceuticals - Off-label prescriptions

Expert: Michael Anisfeld - 10/27/2009

Question
QUESTION: I know that the FDA cannot regulate a physician's prescribing FDA approved drugs for off-label uses, i.e., "uses other than those stated in the product label". My question is: Shouldn't a specific contraindication or warning in the label AGAINST use in a certain class of patients preclude a physician or veterinarian from claiming impunity from prescribing that drug as "off-label"? Two kinds of uses are general "stated in the product label" -- uses that are specifically FDA approved and uses that are specifically contraindicated or warned against. A legitimate off-label use should, by definition, be something other that one of these two labeled categories and there should be no legal protection from malpractice suits for doctors who think they can "go off-label" to get around the contraindications and warnings. Your comments would be greatly appreciated.

ANSWER: Actually, contra-indications are already stated on the label to warn physicians of potential problems, and when not to prescribe the drug.

As such, I'm sorry but I do not understand what point you are trying to make.

---------- FOLLOW-UP ----------

QUESTION: I'm dealing with a veterinarian who firmly believes that there is no problem with his completely ignoring the warnings and contraindications that are on the product label because of his perceived right "to go off label" (i.e., to ignore the label) any time he wishes. I think that ignoring a contraindication clearly stated on the label does NOT meet the FDA's definition of "off-label", and that the vet is not acting according to good medical practice by doing so. (He also believes he has no duty to inform pet owners of the risks involved in his prescribing potentially fatal meds, or to provide the drug label information to pet owners before treatment. The drug, by the way is Metacam Oral Solution, an anti-inflamatory that can cause acute and often fatal renal failure in cats, which is why the label states in bold letters: "For oral use in dogs only. Do not give to cats.") Who's right, the vet or me? We're talking about over $1500 in costs so far for emergency treatment for renal poisoning due to this vet's giant ego and sloppy practices.

Answer
Claire:

You appear to be correct (but as I am not a lawyer, I cannot state that you legally "are correct"). Have you asked him to explain the rationale and logic of his actions?

And ..... if your cat suffers (or dies) due to his actions (which, of course, you have documented from the start of therapy including the conversations you have had with him), you have wonderful grounds for legal proceedings; not that, regrettably, this will assist your cat.

Question - why have you not gone to another vet (if not for therapy, at least for a 2nd opinion?)

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