63384 Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / Notices

1This 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-bycase basis.

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.

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draft guidance documents entitled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on the draft guidance documents to the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 IBernste@bangate.fda.gov.

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, online 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

Data1

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

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 FDAApproved 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,
Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / Notices 63385

2Although 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 caseby-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.

3Printed 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).

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 peerreviewed 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 Texts2

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.

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

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