Replies to post #2464 on Nutra Pharma Corp (NPHC)

[righty]

prove they won't seek fda approval ...ever....prove that

you cannot....you know why?

because it is a ridiculous suggestion

[downsideup]

Its pretty simple...

1. They already have it. The FDA signed off on allowing it to be sold under the rule set they are using.

2. They don't need what they already have. See 1 above.

Cobroxin is an officially approved drug within the meaning of the FDCA.

Otherwise, you are saying what they ARE doing in selling the product under the rules they are violates the requirements ?

What requirements are being violated ?

It is silly season here, apparently... with the argument being that they have some non-existent need to jump through bureaucratic hoops at FDA they don't need to and have no requirement to jump through... because a couple of posters on IHub think they should, even though the government doesn't ?

The FDA recognizes the approval shown in the HPUS as good enough for them.

"Officially recognized in the FDCA, the HPUS was published by the American Institute of Homeopathy, a physicians’ organization, until 1980, when HPCUS was formed as a separate legal entity.9 HPCUS is a standard-setting organization that focuses on the regulatory approval of official homeopathic drug products and the development and publication of general pharmacy practices and standards. At present, 1286 official homeopathic drug products are recognized in the HPUS, a publication in excess of 1600 pages.

Approval standards of HPCUS

The criteria for eligibility for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective...

The clinical benefits of the new drug must be established in one of the following ways: through clinical verification acceptable to HPCUS, after which there is a period of clinical verification; through published documentation that the substance was in use prior to 1962; through use established by at least two adequately controlled double-blind clinical studies using the drug as the single intervention; or through use established by data gathered from clinical experience encompassing the symptom picture before and after treatment, including subjective and any available objective symptoms.10

The criterion of clinical use prior to 1962 was used to grandfather many drugs during the 1970s and 1980s into acceptance. This criterion is now rarely, if ever, used, and HPCUS is rereviewing many monographs accepted under this approach.

HPCUS reports that the criterion of clinical experience has never been used. Consequently, only the criteria of homeopathic drug “proving” and establishment by two adequate clinical studies are currently in actual use (Baker C, personal communication, 2004 Nov).

HPCUS approval process

The process by which judgments are made concerning monographs begins with the submission of a monograph to the HPCUS monograph editor. After review for completeness and formatting, the monograph file is forwarded to the monograph review committee (MRC) for a first review. The MRC is composed primarily of scientists and pharmacists and focuses on the technical aspects of monographs, including substance characterization, quality analysis and controls, assay techniques, and reference reagents, as well as the technical aspects of drug production...

After publication for comment, the monograph and comments are presented to the pharmacopeia revision committee (PRC) for a second review. The PRC consists primarily of clinicians and concerns itself with the proving or clinical trials data and with a second review of technical information. Both the MRC and the PRC review related toxicology and safety data and make recommendations for the dosages at which the drug may be marketed on a nonprescription or prescription-only basis. About 5% of homeopathic drugs sold in the United States are available by prescription only. Like the MRC, the PRC may request more data on a drug, reject it, or accept it. If a monograph is accepted and differences exist between the MRC’s and PRC’s opinions, a joint MRC–PRC meeting may be called to resolve them. After preliminary approval by the MRC and the PRC, the monograph, along with recommendations, is forwarded to the HPCUS board of directors, which makes final decisions. If the board accepts the monograph, the sponsor is so advised and clinical outcomes data are requested. HPCUS collaborates with the monograph sponsor to determine the sample size for these data based on standard criteria of effect size, clinical indications for use, and potential toxicity or adverse effects. Once these data are collected and forwarded to HPCUS, the combined MRC and PRC committees review the clinical outcomes data. If acceptable, the monograph is granted final approval for inclusion in HPUS, and the drug becomes an official approved drug within the meaning of the FDCA."

http://www.hylands.com/news/regulation.php

[cngreen]

Thats why you dont understand the product your bashing. You have no idea whats in it.

[seabreezing]

Could it have anything to do with time and money to go through the process? or the FDA saying they didn't need go further. Does the upcoming focus on MD pain or the planned purchase of a company or 2 yearly mean anything as to the reason? Its kind of rhetorical in nature.I know a running dialogue is not in my interest at all. I took you off ignore because I am a assistant now and just feel its part of being an assistant to view ALL posts when available or worthwhile. seabreezing. Lets all make some money in the market today. That what we are here for right?