McDermott Will & Emery partners with leaders around the world to fuel missions, knock down barriers and shape markets. With more than 1,100 lawyers across several office locations worldwide, our team works seamlessly across practices, industries and geographies to deliver highly effective solutions that propel success.
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(FDA) released a draft guidance entitled "Distributing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."
United StatesFood, Drugs, Healthcare, Life Sciences
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(FDA) released a draft guidance entitled "Distributing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 The draft guidance, which sets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high-level overview of the new draft guidance.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questions regarding the extent to which the 2009 draft guidance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issues, on February 28, 2014, FDA issued a revised draft guidance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In the draft guidance, FDA sets forth "recommended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(e.g., length, scope of topics addressed), the draft
guidance sets forth separate principles for each publication type.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.