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Dear all,
I am interested to gather some information about the U.S. FDA's
perspectives on developing and registering traditional medicines as
drugs. Such remedies often include extracts or parts from several
different plants and the pharmacological effect(s) may be due to the
interactions of several, often unknown, molecules. This cocktail
approach is generally not in line with the puristic view by the agency,
where a single molecule (or combinations of known molecules) are the
norm for registration. My specific interest are for local treatment with
little or no systemic exposure.
Any comment on this issue is appreciated!
Toufigh
--
Toufigh Gordi, PhD
www.tgordi.com
E-mail: tg.aaa.tgordi.com
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Toufigh:
To the best of my recollection, I can not remember a combination traditional medicine approved as a
drug by the FDA. But I am not sure the combination versus single agent is the biggest obstacle in
getting approval.
Most dietary supplement companies go for "supports health" type claims rather than disease
indications because it is so much cheaper. So the first decision is if that disease indication is
worth the cost. It is hard to patent traditional medications so once a company has achieved NDA
approval, any other company could probably market a VERY similar product as a dietary supplement
(there are ways to get around the NDA especially by making support instead of treatment claims) and
get a significant portion of the market (use patents are not great protections).
Secondly, traditional medicines are usually individualized based on a practitioner's evaluation of
the patient and the availability of the herbal components at that time. The third barrier is the
active ingredients and any potentially toxic components are not well known so a company will have to
spend considerable time and money on characterization. Certainly, if the proposed product consists
of a combination of herbs; then that characterization process would be longer and have include
evaluation of potential interactions of the combination.
Finally a company has to be very careful who they partner with for procurement. There are issues of
overharvesting, contamination with toxic herbs, fungus, bacteria and pesticides. I have seen
disasters happen along these lines, so I urge companies to proceed very carefully.
Sincerely,
Carol Collins
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Toufigh,
USP began working on dietary supplements several years ago and have encountered a lot of the issues
you mention. They are a distinct and nonaffiliated organization from the government in general and
the FDA in particular. They do interact though with FDA and I suspect they might have some insights
into the matter. http://www.usp.org/dietary-supplements/overview
Cory
--
Cory Langston, DVM, PhD
Diplomate, American College of Veterinary Clinical Pharmacology
Professor and Service Chief, Small Animal Intensive Care Unit
College of Vet Med
240 Wise Center Drive
Miss. State, MS 39762
langston.aaa.cvm.msstate.edu
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Hi Toufigh
The company ( Regen Therapeutics) where I was medical director until they ran out of investment
funds went along the path of "supports health", as Carol has rightly recommended, for their product
in Alzheimer's [called Colostrinin(R) or Cognisure(R) in the US]. They did a lot of research
showing that it worked in a wide range of lab models of the pathological process of Alzheimer's and
one successful clinical trial, but all that took so long and so much funding that they could not
raise the much bigger funds needed for a Phase 3 type trial. The problem was that it left them in
the limbo of having a diet supplement, or nutraceutical that "supports cognitive function", but
which did not have authorisation for the disease for which it should be indicated. If you've got
the funds for at least one Phase 3, then OK.
Good hunting
Andrew
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