[Federal Register Volume 61, Number 196 (Tuesday, October 8, 1996)]
[Notices]
[Pages 52800-52801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25728]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95D-0377]


Advertising and Promotion; Guidances

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The agency is publishing two guidances entitled ``Guidance to 
Industry on Dissemination of Reprints of Certain Published, Original 
Data'' and ``Guidance for Industry Funded Dissemination of Reference 
Texts.'' These guidances relate to the dissemination, by sponsors of 
human and animal drugs, medical devices, and biological products of 
certain reprints of journal articles and reference texts (medical 
textbooks and compendia), which contain information concerning FDA-
approved products that may not be consistent with the approved labeling 
for the products. These guidances describe the circumstances under 
which the agency intends to allow the dissemination of these reprints 
and reference texts to health care professionals. These guidances are 
intended to assist the agency in fulfilling its mission to help ensure 
the safety and effectiveness of human and animal drugs, medical 
devices, and biological products. The full texts of these guidances are 
published in this document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding general questions: Ilisa B. G. Bernstein, Office of 
Policy (HF-23), Food and Drug Administration, 5600 Fishers Lane, rm. 
15-74, Rockville, MD 20857, 301-827-3380, or via Internet at 
[email protected];
    Regarding human drugs: Patrick O'Brien, Center for Drug Evaluation 
and Research (HFD-40), Food and Drug Administration, 5600 Fishers Lane, 
rm. 17B-17, Rockville, MD 20857, 301-827-3901, or via Internet at 
[email protected];
    Regarding animal drugs: Edward L. Spenser, Division of Surveillance 
(HFV-210), Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1722, 
or via Internet at [email protected];
    Regarding medical devices: Byron L. Tart, Center for Devices and 
Radiological Health (HFZ-302), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20879, 301-594-4639, or via Internet at 
[email protected];
    Regarding biological products: Toni M. Stifano, Center for 
Biologics Evaluation and Research (HFM-202), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via Internet at [email protected]
SUPPLEMENTARY INFORMATION: In the Federal Register of December 8, 1995 
(60 FR 63384), FDA published and sought public comment on two draft 
guidances entitled ``Guidance to Industry on Dissemination of Reprints 
of Certain Published, Original Data'' and ``Guidance for Industry 
Funded Dissemination of Reference Texts.'' These guidances relate to 
the dissemination, by sponsors of human and animal drugs, medical 
devices, and biological products, of certain reprints of journal 
articles and reference texts (medical textbooks and compendia), which 
contain information concerning FDA-approved products that may not be 
consistent with the approved labeling for the products.
    The agency received over 57 comments in response to the request for 
comments on the draft guidances. The comments came from drug and device 
manufacturers, professional health organizations, industry trade 
organizations, patient advocacy organizations, health communications 
specialists, attorneys, and health professionals. The agency has 
reviewed and considered these comments in its analysis of whether and 
what changes should be made in finalizing these guidances. As a result 
of this analysis, the agency has determined that no changes need to be 
made to the ``Guidance to Industry on Dissemination of Reprints of 
Certain Published, Original Data.'' The ``Guidance for Industry Funded 
Dissemination of Reference Texts'' remains essentially unchanged; 
except in the discussion of circumstances for dissemination of 
reference texts, FDA added an additional circumstance concerning 
product promotion, as noted below.
    The agency received several comments claiming that the guidance on 
dissemination of certain reprints does not go far enough, arguing that 
companies should be permitted to disseminate any article they choose, 
regardless of what information is discussed in the article or whether 
the information is consistent with the approved product labeling. The 
agency also received several comments that gave specific suggestions of 
the types of articles that should be permitted under a policy with a 
broader scope (e.g., all peer-reviewed articles, technical reports). 
FDA believes that the guidances that are the subject of this notice 
strike the proper balance between the need for an exchange of reliable 
scientific data and information within the health care community, and 
the statutory requirements that prohibit companies from promoting 
products for unapproved uses. However, the agency will continue to 
evaluate its policies related to the advertising and promotion of FDA-
regulated products, and these guidances are just one part of its policy 
in this area.
    The agency also received comments seeking clarification of certain 
aspects of the guidances. Although these comments were considered in 
determining the final version of these guidances, they are not 
individually addressed in this notice. The agency welcomes questions 
from interested parties regarding the practical application of these 
guidances. Specific questions should be directed to the appropriate 
persons within the agency who address advertising and promotion issues 
for the particular regulated product. (See contact persons above.)
    One comment suggested that sponsors should not be allowed to use 
reprints or reference texts as a tool to promote unapproved uses of 
their products. The agency does not intend for these materials to be 
used in this way. Upon consideration, the agency has determined that an 
additional ``circumstance'' should be added to the

[[Page 52801]]

guidance on reference texts making it clear that company 
representatives should not refer to, or otherwise promote, information 
in the reference text that is not consistent with the approved labeling 
for a product.
    The texts of the final guidance documents follow:

Guidance to Industry on Dissemination of Reprints of Certain Published, 
Original Data \1\
---------------------------------------------------------------------------

    \1\ This guidance does not apply to reprints of articles that 
discuss the specific prohibited uses of animal drugs listed in FDA's 
Center for Veterinary Medicine's Compliance Policy Guide 7125.06 or 
the Animal Medicinal Drug Use Clarification Act implementing 
regulations. Although this guidance does not create or confer any 
rights on any person and does not operate to bind FDA in any way, it 
does represent the agency's current thinking on the dissemination of 
reprints of certain published, original data. The agency will 
consider individual circumstances on a case-by-case basis.
---------------------------------------------------------------------------

I. Purpose of Guidance

    Sponsors frequently want to disseminate reprints of articles 
reporting the results of the effectiveness trials that have been 
relied on by FDA in its approval or clearance of a drug, device, or 
biologic product. However, such articles may contain effectiveness 
rates, data, analyses, uses, regimens, or other information that is 
different from the approved labeling, and might, if disseminated by 
the sponsor, be considered violative promotional activities.
    Nonetheless, the agency intends to allow sponsors to disseminate 
reprints of articles that represent the peer-reviewed, published 
version of original efficacy trials, under the circumstances 
described in section II., below.

II. Circumstances for Dissemination of Certain Journal Articles 
Discussing FDA-Approved Products

    1. The principal subject of the article should be the use(s) or 
indication(s) that has been approved by FDA. The article should be 
published in accordance with the regular peer-review procedure of 
the journal in which it is published, and the article should report 
the original study that was represented by the sponsor, submitted to 
FDA, and accepted by the agency as one of the adequate and well-
controlled studies providing evidence of effectiveness. In the case 
of a medical device, this guidance also applies to studies that were 
otherwise represented by the sponsor, submitted to the agency, and 
accepted by the agency as valid and material evidence of safety or 
effectiveness in lieu of adequate and well-controlled studies;
    2. The reprint should be from a bona fide peer-reviewed journal. 
A bona fide peer-reviewed journal is a journal that uses experts to 
objectively review and select, reject, or provide comments about 
proposed articles. Such experts should have demonstrated expertise 
in the subject of the article under review, and be independent from 
the journal;
    3. If the article contains effectiveness rates, data, analyses, 
uses, regimens, or other information that is different from approved 
labeling, the reprint should prominently state the difference(s), 
with specificity, on the face of the reprint. One acceptable means 
of achieving the appropriate prominence for this statement is to 
permanently affix to the reprint a sticker stating the differences; 
and
    4. The reprint should disclose all material facts and should not 
be false or misleading.

Guidance for Industry Funded Dissemination of Reference Texts \2\
---------------------------------------------------------------------------

    \2\ Although this guidance does not create or confer any rights, 
on any person, and does not operate to bind FDA in any way, it does 
represent the agency's current thinking on industry funded 
dissemination of reference texts. Although FDA believes that this 
guidance encompasses the vast majority of reference texts, the 
agency will consider, on a case-by-case basis, reference texts that 
do not fall within the parameters of this guidance document. This 
guidance does not apply to textbooks or compendia that discuss the 
specific prohibited uses or animal drugs listed in the Center for 
Veterinary Medicine's Compliance Policy Guide 7125.06 or the Animal 
Medicinal Drug Use Clarification Act implementing regulations.
---------------------------------------------------------------------------

I. Purpose of Guidance

    Sponsors have expressed a desire to disseminate reference texts, 
i.e., medical textbooks and compendia, to health care professionals. 
These texts typically discuss a wide range of medical diagnoses and 
treatments, including drug product utilization, surgical techniques, 
and other medical topics, and are often useful to clinicians in the 
practice of medicine.
    Reference texts often contain information about the use of 
drugs, devices, or biologic products in the treatment, diagnosis, or 
prevention of disease that may not be consistent with the FDA-
approved labeling for the products (e.g., discussion of unapproved 
uses). While many textbooks do not necessarily highlight a 
particular drug or device manufacturer's products, the dissemination 
of these reference texts by regulated industry may still be in 
conflict with the Federal Food, Drug, and Cosmetic Act (the act) and 
implementing regulations. \3\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.

    Dated: October 1, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-25728 Filed 10-7-96; 8:45 am]
BILLING CODE 4160-01-F