[Federal Register Volume 60, Number 236 (Friday, December 8, 1995)]
[Notices]
[Pages 63384-63385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30169]




[[Page 63383]]

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Part V





Department of Health and Human Services





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Food and Drug Administration



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Advertising and Promotion; Draft Guidances; Republication; Notice

  Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / 
Notices   

[[Page 63384]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95D-0377]


Advertising and Promotion; Draft Guidances; Republication

    Note: This document was originally published at 60 FR 62471, 
Wednesday, December 6, 1995. Certain text in the guidances were 
inadvertently omitted. For the convenience of the reader, the 
document is being republished in its entirety.
AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing two draft 
guidance documents entitled ``Guidance to Industry on Dissemination of 
Reprints of Certain Published, Original Data'' and ``Guidance for 
Industry Funded Dissemination of Reference Texts.'' These draft 
guidances are related to the dissemination, by sponsors of human and 
animal drugs, medical devices, and biological products, of certain 
reprints of journal articles discussing FDA-approved products, and 
reference texts (medical textbooks and compendia). The draft guidances 
describe circumstances under which the agency would exercise its 
discretion to allow the dissemination of these reprints and reference 
texts to health care professionals.

DATES: Written comments by January 5, 1996.

ADDRESSES: Submit written comments on the draft guidance documents to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, or FAX at 301-594-
3215.

FOR FURTHER INFORMATION CONTACT: 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 
IB[email protected].

SUPPLEMENTARY INFORMATION: Health care professionals have always been 
able to obtain, from a number of different sources, journal articles 
and reference texts (i.e., medical textbooks and compendia), that 
discuss human and animal drugs, medical devices, and biological 
products. These journal articles and reference texts are commercially 
available and may be obtained from publishers, libraries, on-line data 
bases, colleagues, bookstores, companies upon request, or other 
sources. Sponsors of human and animal drugs, medical devices, and 
biological products frequently have expressed a desire to disseminate 
reprints of journal articles and reference texts to health care 
professionals.
    FDA traditionally has taken the position that sponsors who wish to 
distribute articles and reference texts containing information that is 
inconsistent with the FDA-approved labeling for a product may be in 
conflict with the Federal Food, Drug, and Cosmetic Act and implementing 
regulations. The agency's position is based on its mission to help 
ensure the safety and efficacy of human and animal drugs, medical 
devices, and biological products. Sponsors seeking approval or 
clearance to market these products must demonstrate to FDA that the 
products are safe and effective for their intended use(s). Permitting 
sponsors to freely disseminate information that is inconsistent with 
the FDA-approved or cleared use(s) would diminish the incentive for 
sponsors to perform the clinical studies which are necessary to verify 
that the product is safe and effective for the unapproved use. 
Furthermore, information disseminated by a biased source may have a 
greater potential to mislead the health care professional.
    FDA believes that journal articles and reference texts are often 
useful to health care professionals. Accordingly, the agency has 
reviewed its policies to determine if modifications can be made without 
jeopardizing the integrity of the statutorily mandated standard that 
marketed drugs be safe and effective and have adequate directions for 
their intended use(s). After careful review, the agency is proposing to 
modify two of its policies at this time.
    First, under one proposed draft guidance, the agency would allow 
sponsors to disseminate, under certain circumstances, journal articles 
that report the results of well-controlled studies, provided they 
represent the peer-reviewed, published version of original efficacy 
trials used to support approval, licensure, or clearance. Second, under 
the other proposed draft guidance, the agency would allow sponsors to 
disseminate, under certain circumstances, reference texts that discuss 
human or animal drugs, medical devices, or biological products. FDA has 
prepared two draft guidance documents describing the proposed 
circumstances under which the agency would exercise its discretion 
regarding the dissemination of these materials by sponsors.
    FDA is particularly interested in receiving comments on whether the 
reprints discussed in the ``Guidance to Industry on Dissemination of 
Reprints of Certain Published, Original Data'' should be from ``peer-
reviewed'' journals. If so, please comment on what constitutes a 
``peer-reviewed'' journal and what benefits would be afforded if these 
reprints are from ``peer-reviewed'' journals.
    Interested persons may, on or before January 5, 1996, submit to the 
Dockets Management Branch (address and FAX number above) written 
comments on the draft guidance documents. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance documents and 
received comments are available for public examination in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.
    The texts of the draft guidance documents follow:

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

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.

    \1\This guidance does not apply to reprints of articles that 
discuss the specific prohibited uses of animal drugs listed in the 
FDA, Center for Veterinary Medicine 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.
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    Nonetheless, the agency intends to allow the dissemination of 
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 reports 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, 

[[Page 63385]]
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 
utilizes experts to review and objectively 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\

I. Purpose of Guidance

    -Sponsors have also 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. FDA recognizes that 
such texts are often useful to clinicians in the practice of 
medicine.

    \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 Compliance Policy Guide 7125.06 or the Animal 
Medicinal Drug Use Clarification Act implementing regulations.
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    -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). FDA recognizes, however, that many textbooks do not 
necessarily highlight a particular drug or device manufacturers 
products. In such instances, industry's desire to disseminate these 
reference texts may 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).
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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 nor misleading. FDA, therefore, intends to 
allow the dissemination by sponsors of 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 Textbooks

    -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 (see discussion 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 (see discussion 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; 
and
    -5. Specific product information (other than the approved 
package insert) should not be physically appended to the reference 
text.
    The agency recognizes that there are some useful reference texts 
that are written, edited, or published by a sponsor or agent of the 
sponsor. In these instances, FDA intends to allow the distribution of a 
reference text under the circumstances described in paragraphs 3 
through 5 above, when the authorship, editing, and publishing of the 
reference text results in the presentation
of a balanced perspective of the subject matter. Typically, this would 
be evidenced by an authorship and editorial process that fosters input 
from a relatively wide spectrum of sources and that allows for 
information from all sources to be considered.

    Dated: December 6, 1995.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 95-30169 Filed 12-7-95; 10:42 am]
BILLING CODE 4160-01-F