United States:
FDA Updates Guidance Addressing Distribution Of Scientific And Medical Publications On Unapproved New Uses
10 March 2014
McDermott Will & Emery
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On February 28, 2014, the U.S. Food and Drug Administration
(FDA) released a draft guidance entitled "Distributing
Scientific and Medical Publications on Unapproved New Uses –
Recommended Practices." The draft guidance, which sets
forth principles consistent with previous agency pronouncements
regarding the dissemination of off-label information, updates a
guidance released in January 2009 to add recommendations pertaining
to the dissemination of clinical practice guidelines that include
references to off-label use of a manufacturer's
product(s). This On the Subject provides a
high-level overview of the new draft guidance.
In January 2009, the U.S. Food and Drug Administration (FDA)
issued guidance that was intended to provide drug and medical
device manufacturers and their representatives with recommendations
regarding the dissemination of scientific or medical information on
unapproved uses to health care professionals and health care
entities, without such activities being considered evidence of the
manufacturer's intent to promote the product for an off-label
use. Since its publication, however, stakeholders raised
questions regarding the extent to which the 2009 draft guidance
applies to the distribution of clinical practice guidelines (CPGs)
that include (or may include) information regarding off-label use
of the manufacturer's product(s). To address these
issues, on February 28, 2014, FDA issued a revised draft guidance
entitled "
Distributing Scientific and Medical Publications on Unapproved New
Uses – Recommended Practices."
In the draft guidance, FDA sets forth "recommended
practices" specific to the dissemination of three types of
scientific or medical publications—journal articles,
reference texts and CPGs. In recognition of the different
characteristics of each of these types of publications
(e.g., length, scope of topics addressed), the draft
guidance sets forth separate principles for each publication type.
The draft guidance provides recommendations as to (1)
characteristics that a publication should have, (2)
characteristics that a publication must not have, (3)
characteristics that a publication should not have and (4)
the materials/disclosures that should accompany each type
of publication. The following table provides a high-level
overview of FDA's guidance.
|
Journal reprint |
Reference text |
Clinical practice guidelines |
Publication should: |
- Be peer reviewed
- Be an unabridged copy or reprint
- Describe/address adequate and well-controlled clinical
investigations
- Be disseminated with approved labeling
- Be disseminated with a comprehensive bibliography of
publications about the use of the product (if such information
exists)
- Be disseminated with a representative publication that reaches
contrary or different conclusions (if such information exists)
- Be delivered separately from promotional information
The following types of reprints are not considered
consistent with these recommended practices:
- Letters to the editor
- Abstracts
- Reports of healthy volunteer studies
- Publications consisting of statements and/or conclusions but
little or no substantive discussion of the investigation on which
they are based
|
If distributed in its entirety:
- Be based on a systematic review of existing evidence
- Be published by an independent publisher that publishes
educational content for health care professionals and students
- Be the most current version
- Be authored, edited and/or contributed to by experts with
demonstrated expertise in the subject area
- Be peer-reviewed by experts with relevant expertise
- Be sold through usual and customary independent distribution
channels
- Be delivered separately from promotional information
- Be distributed with approved labeling (if one or more
individual chapters devote primary substantive discussion to
manufacturer product(s))
If distributing individual chapters that include
information on off-label use:
- Come from a text that follows the draft guidance's
recommendations for complete reference texts (except chapters
should bear the prominently displayed and permanently affixed
statement described below for use on individual chapters)
- Be unaltered/unabridged and extracted directly from the
reference text in which it appears
- Be disseminated with other unaltered/unabridged chapters from
the text (when necessary to provide context)
- Be disseminated with approved labeling
|
All CPGs:
- Be based on a systematic review of existing evidence
- Be developed by a knowledgeable, multidisciplinary panel of
experts and representatives from key affected groups
- Consider important patient subgroups and patient
preferences
- Be based on an explicit and transparent (publicly accessible)
process by which the CPG is developed and funded that minimizes
distortions, biases and conflicts of interest
- Provide a clear explanation of the logical relationships
between alternative care options and health outcomes
- Provide clearly articulated recommendations in standardized
form
- Provide ratings of quality of evidence and strength of
recommendations
- Be reconsidered when important new evidence warrants
modification of recommendations
If distributing guidelines in their entirety:
- Be the most current version of the CPG
- Be delivered separately from promotional information
If distributing guidelines in their entirety, but one or
more sections contain primary substantive discussion of the
manufacturer's product(s):
- Be distributed with approved labeling
If distributing individual sections that include
information on off-label use:
- Come from a CPG that follows the draft guidance's
recommendations (except chapters should bear the prominently
displayed and permanently affixed statement described below for use
on individual sections)
- Be unaltered/unabridged and extracted directly from the CPG in
which it appears
- Be disseminated with other unaltered/unabridged sections from
the CPG (when necessary to provide context)
- Be disseminated with approved labeling
|
Publication must not: |
- Be false or misleading
- Contain information recommending or suggesting use that makes
the product dangerous to health when used in manner suggested
|
- Be false or misleading
- Contain information recommending or suggesting use that makes
the product dangerous to health when used in manner suggested
|
- Be false or misleading
- Contain information recommending or suggesting use that makes
the product dangerous to health when used in manner suggested
|
Publication should not: |
- Be a special supplement or publication funded (in whole
or in part) by the manufacturer
- Be marked, highlighted, summarized or characterized by the
manufacturer (in writing or orally) to emphasize or promote an
off-label use
- Be primarily distributed by the manufacturer
Be written, edited, excerpted or published specifically for (or at
the request of) the manufacturer
- Be edited or significantly influenced by a manufacturer or
individuals with a financial relationship with the
manufacturer
- Be attached to specific product information (other than
approved labeling)
|
- Be primarily distributed by the manufacturer
- Be edited or significantly influenced by a manufacturer or
individuals with a financial relationship with the
manufacturer
- Be marked, highlighted, summarized or characterized by the
manufacturer (in writing or orally) to emphasize or promote an
off-label use
- Be written or published specifically at the manufacturer's
request
- Be abridged or excerpted in any particular manner
- Be attached to specific product information (other than
approved labeling)
|
- Be primarily distributed by the manufacturer
- Be edited or significantly influenced by a manufacturer or
individuals with a financial relationship with the
manufacturer
- Be marked, highlighted, summarized or characterized by the
manufacturer (in writing or orally) to emphasize or promote an
off-label use
- Be written or published specifically at the manufacturer's
request
- Be abridged or excerpted in any particular manner
- Be attached to specific product information (other than
approved labeling)
|
Publication should be
accompanied by prominently displayed and permanently affixed
statement disclosing: |
- Products referenced in the reprint in which the manufacturer
has an interest
- That some or all uses of the manufacturer's product
described in the information are off-label
- Any author known to the manufacturer as having a financial
relationship with the manufacturer (and the nature of such
relationship)
- Any person known to the manufacturer who funded the study
- All significant risks or safety concerns associated with the
unapproved use that are known to the manufacturer but not discussed
in the article
|
If distributed in its entirety:
- The distributing manufacturer
- That some of the uses described in the text might not be
approved/cleared by FDA
- That the author(s) of some chapters may have a financial
relationship with the manufacturer or its products, unless the
manufacturer has verified that none of the authors has such
relationship
This statement should be placed by sticker, stamp or other
similar means on the front cover of the textbook.
If distributing individual chapters that include
information on off-label use:
- The distributing manufacturer
- The product(s) addressed in which the manufacturer has an
interest
- That some or all uses of the manufacturer's product
described in the information are off-label
- Any author known to the manufacturer as having a financial
relationship with the manufacturer (and the nature of such
relationship)
- All significant risks or safety concerns associated with the
unapproved use that are known to the manufacturer but not discussed
in the chapter(s)
This statement should be placed by sticker, stamp or other
similar means on the front page of each chapter.
|
If distributed in its entirety:
- The distributing manufacturer
- That some of the uses described in the text might not be
approved/cleared by FDA
- That the author(s) of some sections may have a financial
relationship with the manufacturer or its products, unless the
manufacturer has verified that none of the authors has such
relationship
This statement should be placed by sticker, stamp or other similar
means on the front cover of the CPG.
If distributing individual sections that include
information on off-label use:
- The distributing manufacturer
- The product(s) addressed in which the manufacturer has an
interest
- That some or all uses of the manufacturer's product(s)
described in the information are off-label
- Any author known to the manufacturer as having a financial
relationship with the manufacturer (and the nature of such
relationship)
- All significant risks or safety concerns associated with the
unapproved use that are known to the manufacturer but not discussed
in the section(s)
This statement should be placed by sticker, stamp or other similar
means on the front page of each section.
|
If manufacturers distribute scientific or medical publications
as recommended in the draft guidance, FDA does not intend to use
such distribution as evidence of the manufacturer's intent that
the product be used off-label.
FDA recommends that comments regarding the draft guidance be
submitted by May 2, 2014 (to ensure consideration before the agency
begins preparing the final guidance).
Implications
With the exception of a few relatively minor clarifications, the
principles set forth in the draft guidance are consistent with the
principles set forth in the January 2009 guidance.
Nevertheless, the draft guidance is important in that it (1)
reaffirms the fundamental position FDA took in 2009 relative to the
distribution of these types of materials; (2) adds guidance from
the agency regarding the dissemination of CPGs; and (3) sets forth
separate tailored recommendations for journal reprints, reference
texts and CPGs, respectively, based on the unique characteristics
of each type of publication. Importantly, the guidance
reaffirms the need for care in ensuring a separation between
promotional activities and the dissemination of these types of
materials. Manufacturers should take this opportunity to
review (and revise, as appropriate) their standard operating
procedures regarding the dissemination of off-label information to
ensure compliance with the draft guidance, assess the need to
refresh the training program for sales and marketing personnel, and
consider submitting comments to FDA.
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