Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices; Availability, 11793-11796 [2014-04560]
Download as PDF
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
Dated: February 26, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–04613 Filed 2–28–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0053]
Revised Draft Guidance for Industry on
Distributing Scientific and Medical
Publications on Unapproved New
Uses—Recommended Practices;
Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Distributing
Scientific and Medical Publications on
Unapproved New Uses—Recommended
Practices.’’ This draft guidance revises
the final guidance titled ‘‘Good Reprint
Practices for the Distribution of Medical
Journal Articles and Medical or
Scientific Reference Publications on
Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical
Devices’’ published in January 2009.
The revised draft guidance provides
guidance on FDA’s current thinking on
recommended practices for drug or
medical device manufacturers and their
representatives to follow when
distributing to health care professionals
or health care entities scientific or
medical journal articles, scientific or
medical reference texts, or clinical
practice guidelines ((CPGs); all three
collectively referred to as ‘‘scientific and
medical publications’’) that discuss
unapproved new uses for approved
drugs or approved or cleared medical
devices marketed in the United States.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 2, 2014.
Submit either electronic or written
comments on the proposed collection of
information by May 2, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
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and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448; or to the Division of
Small Manufacturers, International and
Consumer Assistance, Office of
Communication, Education and
Radiation Programs, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist the
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Bryant
Godfrey, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 51, Rm. 3258, Silver Spring,
MD 20993–0002, 301–796–1200.
Regarding prescription biological
products: Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
Regarding medical devices: Deborah
Wolf, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring,
MD 20993–0002, 301–796–5732.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised draft guidance for industry
entitled ‘‘Distributing Scientific and
Medical Publications on Unapproved
New Uses—Recommended Practices.’’
This draft guidance describes
recommended practices for drug or
medical device manufacturers or their
representatives to follow when
distributing to health care professionals
or health care entities scientific and
medical publications that discuss
unapproved new uses of approved drugs
or approved or cleared medical devices.
In January 2009, FDA published a
final guidance titled ‘‘Good Reprint
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11793
Practices for the Distribution of Medical
Journal Articles and Medical or
Scientific Reference Publications on
Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical
Devices,’’ which set forth the Agency’s
thinking as of that time regarding the
dissemination by manufacturers of
medical journal articles and scientific or
medical reference publications that
discuss unapproved or uncleared uses
of medical products.1 FDA received
comments to the docket for the 2009
guidance, including submissions
requesting clarification of how the
principles set forth in the 2009 guidance
would apply to medical textbooks and
potential changes to those principles.
In July 2011 and September 2013,
FDA received citizen petitions, filed on
behalf of multiple prescription drug and
medical device manufacturers, that
include several requests related to
FDA’s approach to the distribution of
scientific and medical information
reflecting unapproved or uncleared
uses, specifically including CPGs.2 FDA
continues to consider the specific
requests made in the citizen petitions,
which include requests for issuance or
revision of regulations, and has not yet
reached a final determination on those
petitions.
At the same time, FDA continues
actively to review, analyze, and develop
approaches to a variety of topics of
interest to industry and others,
including issues raised in the petition.
As part of this process, FDA is soliciting
public comment on the draft guidance
made available here. Similarly, as part
of the Agency’s ongoing efforts to
address industry questions, FDA
continues to solicit public input and
consider approaches with respect to
several related issues, including the
following:
(1) Further explaining ‘‘scientific
exchange.’’ On December 28, 2011, FDA
issued a Federal Register notice (76 FR
81508) opening a docket and requesting
comments and information related to
‘‘scientific exchange.’’ Comments were
submitted to Docket No. FDA–2011–N–
0912. FDA is reviewing those comments
and considering how that information
may inform future Agency action related
to its policies on communications and
activities related to unapproved or
uncleared uses of marketed drugs and
devices, as well as communications and
activities related to use of products that
are not yet legally marketed for any use.
1 Please visit https://www.regulations.gov and
enter docket number FDA–2008–D–0053.
2 Please visit https://www.regulations.gov and
enter docket numbers FDA–2011–P–0512 and FDA–
2013–P–1079.
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11794
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
(2) Developing guidance on the issue
of manufacturer responses to
unsolicited requests for information
relating to unapproved or uncleared
uses. In December 2011, FDA issued a
draft guidance entitled ‘‘Responding to
Unsolicited Requests for Off-Label
Information About Prescription Drugs
and Medical Devices.’’ FDA is currently
considering comments on that draft
guidance to inform its further action on
this topic.
(3) Considering draft guidance on
industry interactions with formulary
committees, payors, and similar entities.
This includes clarifying the Agency’s
interpretation of several terms included
in section 114 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) and the
Agency’s recommendations for
evidentiary support for health care
economic information included in
promotional materials disseminated to
formulary committees and similar
entities.
Among the other issues under
evaluation, FDA is considering a range
of options for responding to questions
about industry participation in scientific
discussions and for addressing industry
dissemination of new scientific
information related to approved or
cleared uses of marketed drugs and
devices.
FDA is soliciting public comment on
the revised draft guidance made
available here, which presents
recommended practices for drug or
medical device manufacturers and their
representatives to follow if they choose
to distribute to health care professionals
or health care entities scientific or
medical journal articles, scientific or
medical reference texts, or CPGs that
discuss unapproved or uncleared uses
of legally marketed drugs and devices.
If the recommended practices are
followed, FDA does not intend to use
distribution of these publications as
evidence of the manufacturer’s intent
that the product be used for an
unapproved new use. FDA is issuing the
revised guidance in draft form to enable
the public to provide comments on the
proposed recommendations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115)
and, when finalized, will represent the
Agency’s current thinking on the topic.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
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II. The Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal Agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on the
following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Distributing Scientific and
Medical Publications on Unapproved
New Uses—Recommended Practices.
Description of Respondents:
Respondents to this collection of
information are manufacturers and
distributors (firms) of approved drug
products or approved/cleared medical
devices.
Burden Estimate: The draft guidance
pertains to the distribution of scientific
and medical publications by FDAregulated industry that discuss
unapproved new uses for approved or
cleared products. The draft guidance
explains that FDA’s current position is
that if a manufacturer follows the
recommendations as described in the
draft guidance, FDA does not intend to
use the distribution of the scientific and
medical publications as evidence of
intent that the product be used for an
unapproved new use. Because the draft
guidance recommends that scientific
and medical publications reflecting
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unapproved or uncleared uses that are
distributed have certain characteristics,
and that certain other information be
distributed with them, the guidance
recommends a ‘‘third-party disclosure’’
that constitutes a ‘‘collection of
information’’ under the PRA.
The draft guidance provides
recommendations regarding the
characteristics of scientific and medical
publications that companies may choose
to distribute. Elaborated in more detail
in the draft guidance, these
characteristics in general include that
these publications be from journals,
scientific or medical reference texts, and
CPGs that are produced by independent
sources and meet criteria for
professional/peer review; be based on
specified types of scientific evidence;
and be complete, unabridged, and
without highlighting or characterization
by the manufacturer. In addition, the
draft guidance provides
recommendations for additional
information to be supplied with the
publications.
Specifically, the draft guidance
recommends the following:
Scientific or medical journal articles
should:
• Be disseminated with the approved
labeling or, in the case of a medical
device reviewed under section 510(k) of
the FD&C Act (21 U.S.C. 360(k)),
labeling for the indications in the
product’s cleared indications for use
statement, for each of the
manufacturer’s products that is
included in the distributed article.
• Be disseminated with a
comprehensive bibliography, when such
information exists, of publications
discussing adequate and well-controlled
clinical studies published in scientific
journals, medical journals, or scientific
texts about the use of the drug or
medical device covered by the
information disseminated (unless the
information already includes such a
bibliography).
• Be disseminated with a
representative publication, when such
information exists, that reaches contrary
or different conclusions regarding the
unapproved use—especially when the
conclusions of articles to be
disseminated have been specifically
called into question by another
publication.
• Be accompanied by a prominently
displayed and permanently affixed
statement disclosing:
Æ The drug(s) or device(s) included in
the journal reprint in which the
manufacturer has an interest;
Æ That some or all uses of the
manufacturer’s drugs or devices
described in the information have not
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been approved or cleared by FDA, as
applicable to the described drug(s) or
device(s);
Æ Any author known to the
manufacturer as having a financial
interest in the manufacturer or in a
product of the manufacturer that is
included in the journal article, or who
is receiving compensation from the
manufacturer, along with the affiliation
of the author, to the extent known by
the manufacturer, and the nature and
amount of any such financial interest of
the author or compensation received by
the author from the manufacturer;
Æ Any person known to the
manufacturer who has provided funding
for the study;
Æ All significant risks or safety
concerns associated with the
unapproved use(s) of the manufacturer’s
product(s) discussed in the journal
article that are known to the
manufacturer but not discussed in the
journal article.
Scientific or medical reference texts
should:
• When distributed in their entirety
by a manufacturer:
Æ Contain a prominently displayed
and permanently affixed statement
identifying the distributing
manufacturer and disclosing that some
of the uses for drugs and/or devices
described in the reference text might not
be approved or cleared by FDA. The
statement should also disclose that the
author(s) of some chapters also might
have a financial interest in the
manufacturer or its products, unless the
manufacturer has verified that none of
the authors for the reference text has a
financial interest in the manufacturer or
a product being written about.3 This
statement should be placed by sticker,
stamp, or other similar means on the
front cover of the textbook;
Æ In situations where a reference text
is distributed in its entirety but one or
more individual chapters of that
reference text devote primary
substantive discussion to an individual
product or products of the manufacturer
distributing it, be disseminated with the
approved product labeling for each such
product or, in the case of a medical
device reviewed under section 510(k) of
the FD&C Act, labeling for the
3 If a reference text is distributed in its entirety
with this statement affixed, manufacturers are not
expected to have reviewed every element of the
reference text to identify discussions of off-label
uses of their products. However, even where an
entire reference text is being distributed,
manufacturers should determine whether one or
more individual chapters of that reference text
devote primary substantive discussion to an
individual product or products of the manufacturer
distributing it, in order to determine whether
dissemination of product labeling is recommended.
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indications in the product’s cleared
indications for use statement.
• If, in lieu of an entire scientific or
medical reference text, a manufacturer
distributes an individual chapter(s) that
includes information on unapproved/
uncleared uses of the manufacturer’s
product(s), the chapter(s) should:
Æ When necessary to provide context,
be disseminated with other unaltered/
unabridged chapters extracted directly
from the same scientific or medical
reference text, such as chapters which
provide related or supportive
information;
Æ Contain a prominently displayed
and permanently affixed statement
identifying the distributing
manufacturer and disclosing: (1) The
drug(s) or device(s) addressed in the
individual chapter(s) in which the
manufacturer has an interest; (2) that
some or all uses of the manufacturer’s
drugs and/or devices described in the
ensuing information have not been
approved or cleared by FDA, as
applicable to the described drug(s) or
medical device(s); (3) any author known
to the manufacturer as having a
financial interest in the manufacturer or
in a product of the manufacturer that is
included in the individual chapter(s), or
who is receiving compensation from the
manufacturer, along with the affiliation
of the author, to the extent known by
the manufacturer, and the nature and
amount of any such financial interest of
the author or compensation received by
the author from the manufacturer; and
(4) all significant risks or safety
concerns associated with the
unapproved use(s) of the manufacturer’s
products discussed in the individual
chapter(s) that are known to the
manufacturer but not discussed in the
chapter(s);
Æ Be disseminated with the approved
labeling, or, in the case of a medical
device reviewed under section 510(k) of
the FD&C Act, labeling for the
indications in the cleared indications
for use statement, for each of the
manufacturer’s products that are
included in the distributed chapter(s).
CPGs should:
• When distributed by a manufacturer
in their entirety:
Æ Contain a prominently displayed
and permanently affixed statement
identifying the distributing
manufacturer and disclosing that some
of the uses of drugs and/or devices
described in the CPG might not be
approved or cleared by FDA. The
statement should also disclose that the
author(s) of some sections might have a
financial interest in the manufacturer or
its products, unless the manufacturer
has verified that none of the authors for
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11795
the CPG has a financial interest in the
manufacturer or a product being written
about. This statement should be placed
by sticker, stamp, or other similar means
on the front page of the CPG.
Æ In situations where a CPG is
distributed in its entirety but one or
more individual sections of that CPG
devotes primary substantive discussion
to an individual product or products of
the manufacturer distributing it, be
disseminated with the approved
product labeling for each such product
or, in the case of a medical device
reviewed under section 510(k) of the
FD&C Act, labeling for the indications
in the product’s cleared indications for
use statement.
• If, in lieu of an entire CPG, a
manufacturer distributes an individual
section(s) that includes information on
unapproved/uncleared uses of the
manufacturer’s product(s), the section(s)
should:
Æ When necessary to provide context,
be disseminated with other unaltered/
unabridged sections extracted directly
from the same CPG, such as sections
which provide related or supportive
information;
Æ Contain a prominently displayed
and permanently affixed statement
identifying the distributing
manufacturer and disclosing: (1) The
drug(s) or device(s) addressed in the
individual section(s) in which the
manufacturer has an interest; (2) that
some or all uses of the manufacturer’s
drugs and/or devices described in the
attached information have not been
approved or cleared by FDA, as
applicable to the described drug(s) or
medical device(s); (3) any author known
to the manufacturer as having a
financial interest in the manufacturer or
in a product of the manufacturer that is
included in the individual section(s), or
who is receiving compensation from the
manufacturer, along with the affiliation
of the author, to the extent known by
the manufacturer, and the nature and
amount of any such financial interest of
the author or compensation received by
the author from the manufacturer; and
(4) all significant risks or safety
concerns associated with the
unapproved use(s) of the manufacturer’s
products discussed in the individual
section(s) that are known to the
manufacturer but not discussed in the
section(s).
Æ Be disseminated with the approved
labeling, or, in the case of a medical
device reviewed under section 510(k) of
the FD&C Act, labeling for the
indications in the cleared indications
for use statement, for each of the
manufacturer’s products that is
included in the distributed section(s).
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Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
FDA estimates that approximately 400
firms (‘‘number of respondents’’ in table
1) distribute scientific and medical
publications that discuss unapproved
new uses for FDA-approved or -cleared
products. FDA also estimates that each
firm would include some or all of the
additional information described
previously when distributing annually a
total of approximately 40,000 scientific
or medical journal articles, scientific or
medical reference texts, or CPGs (‘‘total
annual disclosures’’ in table 1) that
discuss unapproved new uses for FDA-
approved or -cleared products. FDA
estimates that it will take each firm
approximately 4 hours (‘‘hours per
disclosure’’ in table 1) to make the
disclosures recommended in this draft
guidance.
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Draft guidance on distributing scientific and medical
information on unapproved new uses
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Distribution of scientific and medical information on unapproved
new uses ..................................................................................
400
100
40,000
4
160,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: February 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04560 Filed 2–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2014–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public. The meeting of the Ophthalmic
Devices Panel Advisory Committee
scheduled for February 14, 2014, was
postponed due to unanticipated weather
conditions and rescheduled for March
14, 2014.
Name of Committee: Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on March 14, 2014, from 8 a.m. to
6 p.m. This meeting is being
rescheduled because of a postponed
meeting announced in the Federal
Register of December 24, 2013 (78 FR
77688), originally scheduled for
February 14, 2014.
Location: Hilton Washington, DC/
North, 620 Perry Pkwy., Gaithersburg,
MD 20877. The hotel’s phone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20933, 301–
796–5920, Natasha.Facey@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/Advisory
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
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learn about possible modifications
before coming to the meeting.
Agenda: On March 14, 2014, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application for the Visian
Toric Implantable Collamer Lens (TICL)
sponsored by STAAR Surgical
Company. ‘‘Visian TICL proposed
indications for use:
• For adults 21–45 years of age;
• For correction of myopic
astigmatism in adults with spherical
equivalent ranging from -3.0D to ≤15.0D with cylinder of 1.0D to 4.0D;
• For the reduction of myopic
astigmatism in adults with spherical
equivalent ranging from greater than
-15.0D to -20.0D with cylinder 1.0D to
4.0D;
• With an anterior chamber depth
(ACD) of 3.0 mm or greater, when
measured from the corneal endothelium
to the anterior surface of the crystalline
lens and a stable refractive history
(within 0.5 Diopter for 1 year prior to
implantation); and
• The Visian TICL is intended for
placement in the posterior chamber
(ciliary sulcus) of the phakic eye.’’
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
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Agencies
[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11793-11796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04560]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0053]
Revised Draft Guidance for Industry on Distributing Scientific
and Medical Publications on Unapproved New Uses--Recommended Practices;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Distributing Scientific and Medical Publications on Unapproved New
Uses--Recommended Practices.'' This draft guidance revises the final
guidance titled ``Good Reprint Practices for the Distribution of
Medical Journal Articles and Medical or Scientific Reference
Publications on Unapproved New Uses of Approved Drugs and Approved or
Cleared Medical Devices'' published in January 2009. The revised draft
guidance provides guidance on FDA's current thinking on recommended
practices for drug or medical device manufacturers and their
representatives to follow when distributing to health care
professionals or health care entities scientific or medical journal
articles, scientific or medical reference texts, or clinical practice
guidelines ((CPGs); all three collectively referred to as ``scientific
and medical publications'') that discuss unapproved new uses for
approved drugs or approved or cleared medical devices marketed in the
United States.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 2, 2014. Submit either electronic or written comments
on the proposed collection of information by May 2, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448; or to the
Division of Small Manufacturers, International and Consumer Assistance,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist the office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription drugs: Bryant Godfrey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 51, Rm. 3258, Silver Spring, MD 20993-0002, 301-
796-1200.
Regarding prescription biological products: Stephen Ripley, Center
for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, 301-827-6210.
Regarding medical devices: Deborah Wolf, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002, 301-796-5732.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Distributing Scientific and Medical Publications on
Unapproved New Uses--Recommended Practices.'' This draft guidance
describes recommended practices for drug or medical device
manufacturers or their representatives to follow when distributing to
health care professionals or health care entities scientific and
medical publications that discuss unapproved new uses of approved drugs
or approved or cleared medical devices.
In January 2009, FDA published a final guidance titled ``Good
Reprint Practices for the Distribution of Medical Journal Articles and
Medical or Scientific Reference Publications on Unapproved New Uses of
Approved Drugs and Approved or Cleared Medical Devices,'' which set
forth the Agency's thinking as of that time regarding the dissemination
by manufacturers of medical journal articles and scientific or medical
reference publications that discuss unapproved or uncleared uses of
medical products.\1\ FDA received comments to the docket for the 2009
guidance, including submissions requesting clarification of how the
principles set forth in the 2009 guidance would apply to medical
textbooks and potential changes to those principles.
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\1\ Please visit https://www.regulations.gov and enter docket
number FDA-2008-D-0053.
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In July 2011 and September 2013, FDA received citizen petitions,
filed on behalf of multiple prescription drug and medical device
manufacturers, that include several requests related to FDA's approach
to the distribution of scientific and medical information reflecting
unapproved or uncleared uses, specifically including CPGs.\2\ FDA
continues to consider the specific requests made in the citizen
petitions, which include requests for issuance or revision of
regulations, and has not yet reached a final determination on those
petitions.
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\2\ Please visit https://www.regulations.gov and enter docket
numbers FDA-2011-P-0512 and FDA-2013-P-1079.
---------------------------------------------------------------------------
At the same time, FDA continues actively to review, analyze, and
develop approaches to a variety of topics of interest to industry and
others, including issues raised in the petition. As part of this
process, FDA is soliciting public comment on the draft guidance made
available here. Similarly, as part of the Agency's ongoing efforts to
address industry questions, FDA continues to solicit public input and
consider approaches with respect to several related issues, including
the following:
(1) Further explaining ``scientific exchange.'' On December 28,
2011, FDA issued a Federal Register notice (76 FR 81508) opening a
docket and requesting comments and information related to ``scientific
exchange.'' Comments were submitted to Docket No. FDA-2011-N-0912. FDA
is reviewing those comments and considering how that information may
inform future Agency action related to its policies on communications
and activities related to unapproved or uncleared uses of marketed
drugs and devices, as well as communications and activities related to
use of products that are not yet legally marketed for any use.
[[Page 11794]]
(2) Developing guidance on the issue of manufacturer responses to
unsolicited requests for information relating to unapproved or
uncleared uses. In December 2011, FDA issued a draft guidance entitled
``Responding to Unsolicited Requests for Off-Label Information About
Prescription Drugs and Medical Devices.'' FDA is currently considering
comments on that draft guidance to inform its further action on this
topic.
(3) Considering draft guidance on industry interactions with
formulary committees, payors, and similar entities. This includes
clarifying the Agency's interpretation of several terms included in
section 114 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) and the Agency's recommendations for evidentiary
support for health care economic information included in promotional
materials disseminated to formulary committees and similar entities.
Among the other issues under evaluation, FDA is considering a range
of options for responding to questions about industry participation in
scientific discussions and for addressing industry dissemination of new
scientific information related to approved or cleared uses of marketed
drugs and devices.
FDA is soliciting public comment on the revised draft guidance made
available here, which presents recommended practices for drug or
medical device manufacturers and their representatives to follow if
they choose to distribute to health care professionals or health care
entities scientific or medical journal articles, scientific or medical
reference texts, or CPGs that discuss unapproved or uncleared uses of
legally marketed drugs and devices. If the recommended practices are
followed, FDA does not intend to use distribution of these publications
as evidence of the manufacturer's intent that the product be used for
an unapproved new use. FDA is issuing the revised guidance in draft
form to enable the public to provide comments on the proposed
recommendations.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115) and, when finalized, will
represent the Agency's current thinking on the topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.
II. The Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Distributing Scientific and Medical Publications on
Unapproved New Uses--Recommended Practices.
Description of Respondents: Respondents to this collection of
information are manufacturers and distributors (firms) of approved drug
products or approved/cleared medical devices.
Burden Estimate: The draft guidance pertains to the distribution of
scientific and medical publications by FDA-regulated industry that
discuss unapproved new uses for approved or cleared products. The draft
guidance explains that FDA's current position is that if a manufacturer
follows the recommendations as described in the draft guidance, FDA
does not intend to use the distribution of the scientific and medical
publications as evidence of intent that the product be used for an
unapproved new use. Because the draft guidance recommends that
scientific and medical publications reflecting unapproved or uncleared
uses that are distributed have certain characteristics, and that
certain other information be distributed with them, the guidance
recommends a ``third-party disclosure'' that constitutes a ``collection
of information'' under the PRA.
The draft guidance provides recommendations regarding the
characteristics of scientific and medical publications that companies
may choose to distribute. Elaborated in more detail in the draft
guidance, these characteristics in general include that these
publications be from journals, scientific or medical reference texts,
and CPGs that are produced by independent sources and meet criteria for
professional/peer review; be based on specified types of scientific
evidence; and be complete, unabridged, and without highlighting or
characterization by the manufacturer. In addition, the draft guidance
provides recommendations for additional information to be supplied with
the publications.
Specifically, the draft guidance recommends the following:
Scientific or medical journal articles should:
Be disseminated with the approved labeling or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act (21
U.S.C. 360(k)), labeling for the indications in the product's cleared
indications for use statement, for each of the manufacturer's products
that is included in the distributed article.
Be disseminated with a comprehensive bibliography, when
such information exists, of publications discussing adequate and well-
controlled clinical studies published in scientific journals, medical
journals, or scientific texts about the use of the drug or medical
device covered by the information disseminated (unless the information
already includes such a bibliography).
Be disseminated with a representative publication, when
such information exists, that reaches contrary or different conclusions
regarding the unapproved use--especially when the conclusions of
articles to be disseminated have been specifically called into question
by another publication.
Be accompanied by a prominently displayed and permanently
affixed statement disclosing:
[cir] The drug(s) or device(s) included in the journal reprint in
which the manufacturer has an interest;
[cir] That some or all uses of the manufacturer's drugs or devices
described in the information have not
[[Page 11795]]
been approved or cleared by FDA, as applicable to the described drug(s)
or device(s);
[cir] Any author known to the manufacturer as having a financial
interest in the manufacturer or in a product of the manufacturer that
is included in the journal article, or who is receiving compensation
from the manufacturer, along with the affiliation of the author, to the
extent known by the manufacturer, and the nature and amount of any such
financial interest of the author or compensation received by the author
from the manufacturer;
[cir] Any person known to the manufacturer who has provided funding
for the study;
[cir] All significant risks or safety concerns associated with the
unapproved use(s) of the manufacturer's product(s) discussed in the
journal article that are known to the manufacturer but not discussed in
the journal article.
Scientific or medical reference texts should:
When distributed in their entirety by a manufacturer:
[cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing that
some of the uses for drugs and/or devices described in the reference
text might not be approved or cleared by FDA. The statement should also
disclose that the author(s) of some chapters also might have a
financial interest in the manufacturer or its products, unless the
manufacturer has verified that none of the authors for the reference
text has a financial interest in the manufacturer or a product being
written about.\3\ This statement should be placed by sticker, stamp, or
other similar means on the front cover of the textbook;
---------------------------------------------------------------------------
\3\ If a reference text is distributed in its entirety with this
statement affixed, manufacturers are not expected to have reviewed
every element of the reference text to identify discussions of off-
label uses of their products. However, even where an entire
reference text is being distributed, manufacturers should determine
whether one or more individual chapters of that reference text
devote primary substantive discussion to an individual product or
products of the manufacturer distributing it, in order to determine
whether dissemination of product labeling is recommended.
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[cir] In situations where a reference text is distributed in its
entirety but one or more individual chapters of that reference text
devote primary substantive discussion to an individual product or
products of the manufacturer distributing it, be disseminated with the
approved product labeling for each such product or, in the case of a
medical device reviewed under section 510(k) of the FD&C Act, labeling
for the indications in the product's cleared indications for use
statement.
If, in lieu of an entire scientific or medical reference
text, a manufacturer distributes an individual chapter(s) that includes
information on unapproved/uncleared uses of the manufacturer's
product(s), the chapter(s) should:
[cir] When necessary to provide context, be disseminated with other
unaltered/unabridged chapters extracted directly from the same
scientific or medical reference text, such as chapters which provide
related or supportive information;
[cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing: (1)
The drug(s) or device(s) addressed in the individual chapter(s) in
which the manufacturer has an interest; (2) that some or all uses of
the manufacturer's drugs and/or devices described in the ensuing
information have not been approved or cleared by FDA, as applicable to
the described drug(s) or medical device(s); (3) any author known to the
manufacturer as having a financial interest in the manufacturer or in a
product of the manufacturer that is included in the individual
chapter(s), or who is receiving compensation from the manufacturer,
along with the affiliation of the author, to the extent known by the
manufacturer, and the nature and amount of any such financial interest
of the author or compensation received by the author from the
manufacturer; and (4) all significant risks or safety concerns
associated with the unapproved use(s) of the manufacturer's products
discussed in the individual chapter(s) that are known to the
manufacturer but not discussed in the chapter(s);
[cir] Be disseminated with the approved labeling, or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act,
labeling for the indications in the cleared indications for use
statement, for each of the manufacturer's products that are included in
the distributed chapter(s).
CPGs should:
When distributed by a manufacturer in their entirety:
[cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing that
some of the uses of drugs and/or devices described in the CPG might not
be approved or cleared by FDA. The statement should also disclose that
the author(s) of some sections might have a financial interest in the
manufacturer or its products, unless the manufacturer has verified that
none of the authors for the CPG has a financial interest in the
manufacturer or a product being written about. This statement should be
placed by sticker, stamp, or other similar means on the front page of
the CPG.
[cir] In situations where a CPG is distributed in its entirety but
one or more individual sections of that CPG devotes primary substantive
discussion to an individual product or products of the manufacturer
distributing it, be disseminated with the approved product labeling for
each such product or, in the case of a medical device reviewed under
section 510(k) of the FD&C Act, labeling for the indications in the
product's cleared indications for use statement.
If, in lieu of an entire CPG, a manufacturer distributes
an individual section(s) that includes information on unapproved/
uncleared uses of the manufacturer's product(s), the section(s) should:
[cir] When necessary to provide context, be disseminated with other
unaltered/unabridged sections extracted directly from the same CPG,
such as sections which provide related or supportive information;
[cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing: (1)
The drug(s) or device(s) addressed in the individual section(s) in
which the manufacturer has an interest; (2) that some or all uses of
the manufacturer's drugs and/or devices described in the attached
information have not been approved or cleared by FDA, as applicable to
the described drug(s) or medical device(s); (3) any author known to the
manufacturer as having a financial interest in the manufacturer or in a
product of the manufacturer that is included in the individual
section(s), or who is receiving compensation from the manufacturer,
along with the affiliation of the author, to the extent known by the
manufacturer, and the nature and amount of any such financial interest
of the author or compensation received by the author from the
manufacturer; and (4) all significant risks or safety concerns
associated with the unapproved use(s) of the manufacturer's products
discussed in the individual section(s) that are known to the
manufacturer but not discussed in the section(s).
[cir] Be disseminated with the approved labeling, or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act,
labeling for the indications in the cleared indications for use
statement, for each of the manufacturer's products that is included in
the distributed section(s).
[[Page 11796]]
FDA estimates that approximately 400 firms (``number of
respondents'' in table 1) distribute scientific and medical
publications that discuss unapproved new uses for FDA-approved or -
cleared products. FDA also estimates that each firm would include some
or all of the additional information described previously when
distributing annually a total of approximately 40,000 scientific or
medical journal articles, scientific or medical reference texts, or
CPGs (``total annual disclosures'' in table 1) that discuss unapproved
new uses for FDA-approved or -cleared products. FDA estimates that it
will take each firm approximately 4 hours (``hours per disclosure'' in
table 1) to make the disclosures recommended in this draft guidance.
Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Draft guidance on distributing
scientific and medical Number of Number of Total annual Average
information on unapproved new respondents disclosures per disclosures burden per Total hours
uses respondent disclosure
----------------------------------------------------------------------------------------------------------------
Distribution of scientific and 400 100 40,000 4 160,000
medical information on
unapproved new uses............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.
Dated: February 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04560 Filed 2-28-14; 8:45 am]
BILLING CODE 4160-01-P