Barb,
Now that the word is out about Dr. Stookey's actual comment on Enamelon's performance as a fluoride toothpaste, I thought I would also finally include the FDA monograph for your review.
frwebgate3.access.gpo.gov
It would be interesting to see if Enamelon is acting consistently with the monograph.
As for using peer-reviewed literature, the FDA has specific guidelines as described below:
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\3\ Printed materials, such as medical textbooks and compendia,
which supplement, explain, or are textually related to a regulated
product are considered labeling for that product when disseminated
by or on behalf of the manufacturer, packer, or distributor of the
product. See section 201(m) of the act (21 U.S.C. 321(m)) and Kordel
v. United States, 338 U.S. 345, 350 (1948).
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Nonetheless, FDA intends to permit the distribution of sound,
authoritative materials that are written, published, and
disseminated independent of the commercial interest of a sponsoring
company and are not false or misleading. FDA, therefore, intends to
allow sponsors to disseminate reference texts that discuss human or
animal drug, device, or biologic products, under the circumstances
described in section II., below.
II. Circumstances for Dissemination of Reference Texts
1. The reference text should not have been written, edited,
excerpted, or published specifically for, or at the request of, a
drug, device, or biologic firm, unless the text was prepared in a
manner that results in a balanced presentation of the subject matter
(see III. below);
2. The content of the reference text should not have been
reviewed, edited, or significantly influenced by a drug, device, or
biologic firm, or agent thereof, unless the text was prepared in a
manner that results in a balanced presentation of the subject matter
(see III. below);
3. The reference text should not be distributed only or
primarily through drug, device, or biologic firms (e.g., it should
be generally available for sale in bookstores or other distribution
channels where similar books are normally available);
4. The reference text should not focus primarily on any
particular drug(s), device(s), or biologic(s) of the disseminating
company, nor should it have a significant focus on unapproved uses
of the drug(s), device(s), or biologic(s) marketed or under
investigation by the firm supporting the dissemination of the text;
5. Specific product information (other than the approved package
insert) should not be physically appended to the reference text; and
6. A drug, device, or biological product company representative
should not refer to, or otherwise promote, in any manner or at any
time, information in the reference text that is not consistent with
the approved labeling for a product.
III. Exception
The agency recognizes that there are some useful reference texts
that are written, edited, or published by a sponsor or agent of a
sponsor. In those instances, where the authorship, editing, and
publishing of the reference text results in a balanced presentation
of the subject matter, FDA intends to allow the distribution of a
reference text under the circumstances described in paragraphs 3
through 6 above. Typically, evidence of a balanced presentation of
the subject matter would consist of an authorship and editorial
process that fosters input from a relatively wide spectrum of
sources and allows for consideration of information from all
sources. |
