Guidance for Industry on 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; Availability, 1694-1695 [E9-452]
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Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0053]
Guidance for Industry on 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; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘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.’’ The guidance
provides drug, biologics, and device
manufacturers with the agency’s views
on the distribution of medical journal
articles and scientific or medical
reference publications that discuss
unapproved new uses for FDA-approved
drugs or biologics or FDA-approved or
cleared medical devices to healthcare
professionals and healthcare entities.
DATES: Submit written or electronic
comments on agency guidances at any
time.
Submit written requests for
single copies of the guidance to the
Office of Policy, Office of the
Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4305, Silver Spring,
MD, 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm.1061, Rockville,
MD 20852. Submit electronic comments
to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Office
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, rm. 4305, Silver Spring,
MD, 20993–0002, 301–796–4830.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
The guidance provides drug,
biologics, and device manufacturers
VerDate Nov<24>2008
19:10 Jan 12, 2009
Jkt 217001
with the agency’s views on the
distribution of medical journal articles
and scientific or medical reference
publications that discuss unapproved
new uses for FDA-approved drugs
(including biologics) or FDA-approved
or cleared medical devices to healthcare
professionals and healthcare entities. In
the Federal Register of February 20,
2008 (73 FR 9342), FDA announced the
availability of a draft guidance for
industry entitled ‘‘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.’’ FDA received several
comments on the draft guidance and
those comments were considered as the
guidance was finalized.
On September 30, 2006, section 401 of
the Food and Drug Administration
Modernization Act (FDAMA) (section
551 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360aaa)) ceased
to be in effect. The provision described
certain conditions under which a drug
or medical device manufacturer could
disseminate medical and scientific
information discussing unapproved uses
of approved drugs and cleared or
approved medical devices to healthcare
professionals and certain entities
(including pharmacy benefits managers,
health insurance issuers, group health
plans, and Federal or State
governmental agencies). Section 401 of
FDAMA provided that, if the described
conditions were met, dissemination of
such journal articles or reference
publications would not be considered as
evidence of the manufacturer’s intent
that the product be used for an
unapproved new use. FDAimplementing regulations were codified
at 21 CFR part 99. In light of the sunset
of section 401 of FDAMA and in
recognition of the public health value to
healthcare professionals of receiving
scientific and medical information, FDA
determined that its current views and
recommendations concerning ‘‘Good
Reprint Practices’’ for the dissemination
of medical journal articles and medical
or scientific reference publications on
unapproved uses of drugs and medical
devices were important. The sunset of
the statutory provision eliminated the
authority of FDA to require submission
of articles for the agency’s review before
dissemination by the manufacturers in
instances where the manufacturer chose
to disseminate information under these
provisions. In the absence of that ability
to require such submissions and the fact
that the implementing regulations are
no longer applicable, the agency
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
determined that guidance to
manufacturers was appropriate because
the agency no longer reviews individual
articles.
With this guidance, FDA is providing
its current views on the dissemination
of medical journal articles and medical
or scientific reference publications on
unapproved uses of approved drugs and
approved or cleared medical devices to
healthcare professionals and healthcare
entities. FDA’s legal authority to
determine whether certain distributions
of medical or scientific information
constitutes promotion of an unapproved
‘‘new use,’’ or whether such activities
cause a product to be misbranded or
adulterated has not changed.
Some of the changes made to the
guidance based on comments received,
and on FDA’s own initiative, include a
specific reference encouraging
manufacturers to seek approvals and
clearance for new indications and
intended uses for medical products.
FDA recognizes the value of new
indications and uses for approved
products and wants these to be studied
so that patients and healthcare
professionals receive safe and effective
treatments. Many comments suggested
that FDA continue to require presubmission of the articles and suggested
other mandatory review practices.
However, given the sunset of section
401 of FDAMA these were not within
FDA’s authority and thus outside the
scope of this guidance. Section IV of the
guidance clarifies a number of bullet
points to address comments expressing
confusion as to some of the terms and
practices expressed. Additional
information was provided to distinguish
the dissemination of these types of
articles from other industry practices.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on the dissemination of
medical journal articles and medical or
scientific reference publications on
unapproved uses of approved drugs and
approved or cleared medical devices to
healthcare professionals and healthcare
entities. 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 applicable statutes and
regulations.
II. Comments
Interested persons may, at any time,
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the
guidance. Submit a single copy of
E:\FR\FM\13JAN1.SGM
13JAN1
Federal Register / Vol. 74, No. 8 / Tuesday, January 13, 2009 / Notices
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. A copy of the guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/oc/op/
goodreprint.html or https://
www.regulations.gov.
Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–452 Filed 1–12–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0674]
Participation of Certain Population
Subsets in Clinical Drug Trials;
Request for Comment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is seeking
information and comments on issues
related to the enrollment of certain
populations in clinical drug trials.
Particularly, we are requesting
information and comments from
medical product manufacturers,
institutional review boards (IRBs),
patient groups, universities, researchers,
community groups, and other interested
parties. This request is related to FDA’s
implementation of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) section 901, which
requires recommendations be included
in a report to Congress addressing best
practice approaches on increasing the
participation of elderly populations,
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19:10 Jan 12, 2009
Jkt 217001
children, racially and ethnically diverse
communities, and medically
underserved populations in clinical
drug trials. FDA requests that those with
information on possible approaches to
increase participation of these groups in
clinical drug trials submit comments.
DATES: Submit written or electronic
comments by February 27, 2009.
ADDRESSES: Submit electronic
comments 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:
Brenda Evelyn, Office of Special Health
Issues, Office of the Commissioner,
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–4460.
SUPPLEMENTARY INFORMATION:
I. Background
Section 901 of FDAAA requires that
FDA submit a report to Congress that
includes ‘‘recommendations regarding
impediments to the participation of
elderly populations, children, racially
and ethnically diverse communities and
medically underserved populations in
clinical drug trials’’ and
recommendations that address ‘‘best
practice approaches for increasing the
inclusion of such subsets of the general
population’’ in clinical drug trials
(FDAAA, section 901(d)(5)). In
developing this report, FDA seeks
comments that may help to develop
these recommendations.
Participation of all segments of the
population in medical research is
critical to public health. The ability to
develop drugs that are safe and effective
for diverse groups hinges on the
availability of clinical drug trial
participants from these same groups.
Some researchers and public health
experts argue that inconsistent
representation of certain communities
can potentially lead to health disparities
and insufficient data for risk
assessment. FDA has previously
identified the need for inclusion of
children, both sexes, the elderly,
racially and ethnically diverse
communities, and other populations in
clinical trials so that data are available
to evaluate the potential differences
among these subgroups (63 FR 6854,
February 11, 1998). According to the
Department of Health and Human
Services (HHS) Office of Minority
Health, in a recent prostate cancer
study, only 8 percent of the 18,000
participants were minorities
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Fmt 4703
Sfmt 4703
1695
(www.omhrc.gov/templates/
content.aspx?ID=5147). Increased
participation from all of these subgroups may help assure that data
relevant to the entire treatment
population are obtained.
In addition, statutory mandates and
incentives such as the Pediatric
Research Equity Act (PREA) (Public Law
No. 108–155 as amended by FDAAA)
and the Best Pharmaceuticals for
Children Act (BPCA) (Public Law No.
107–109 as amended by FDAAA)
require and encourage medical research
to consider implications for pediatric
populations.
For over 20 years, FDA has worked to
encourage broad participation of all
groups in clinical drug trials. Under
FDA regulations (21 CFR 312.33), all
investigational new drug (IND)
applications must include in annual
reports the number of patients tabulated
by age, gender, and race, and under 21
CFR 314.50(d)(5)(v) and (d)(5)(vi), new
drug applications (NDA) are required to
include analyses of efficacy and safety
by demographic subgroups. Biologics
license applications typically include
analyses of efficacy and safety by
demographic subgroups. The
International Conference on
Harmonization (ICH) guidance on the
common technical document also calls
for such analyses (see M4E: The CTD—
Efficacy (August 2001) available at
https://www.fda.gov/cber/gdlns/
m4ectd.pdf.).
FDA has issued labeling
recommendations for specific subpopulations (Guidance for Industry:
Content and Format of the Adverse
Reactions Section of Labeling for
Human Prescription Drugs and
Biological Products, January 2006,
available at https://www.fda.gov/cber/
gdlns/cfadvers.htm) and guidelines for
studying gender differences in clinical
drug studies (Guideline for the Study
and Evaluation of Gender, July 1993,
available at https://www.fda.gov/cder/
Guidance/old036fn.pdf). FDA has made
recommendations for minimum
standards for the collection and use of
race and ethnicity information to assist
in the reporting of the summary of
safety and effectiveness data by
demographic subgroups (age, gender,
race), as well as an analysis of whether
modifications of dose or dosage
intervals are needed for specific
subgroups. (Guidance for Industry:
Collection of Race and Ethnicity Data in
Clinical Trials, September 2005,
available at https://www.fda.gov/CBER/
gdlns/racethclin.htm; see, also ICH E–7
Guideline for Industry, Studies in
Support of Special Populations:
Geriatrics (August 1994) available at
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 74, Number 8 (Tuesday, January 13, 2009)]
[Notices]
[Pages 1694-1695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-452]
[[Page 1694]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0053]
Guidance for Industry on 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; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``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.'' The guidance provides
drug, biologics, and device manufacturers with the agency's views on
the distribution of medical journal articles and scientific or medical
reference publications that discuss unapproved new uses for FDA-
approved drugs or biologics or FDA-approved or cleared medical devices
to healthcare professionals and healthcare entities.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Policy, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4305, Silver
Spring, MD, 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm.1061,
Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy,
Office of the Commissioner, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4305, Silver Spring, MD, 20993-0002, 301-
796-4830.
SUPPLEMENTARY INFORMATION:
I. Background
The guidance provides drug, biologics, and device manufacturers
with the agency's views on the distribution of medical journal articles
and scientific or medical reference publications that discuss
unapproved new uses for FDA-approved drugs (including biologics) or
FDA-approved or cleared medical devices to healthcare professionals and
healthcare entities. In the Federal Register of February 20, 2008 (73
FR 9342), FDA announced the availability of a draft guidance for
industry entitled ``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.'' FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized.
On September 30, 2006, section 401 of the Food and Drug
Administration Modernization Act (FDAMA) (section 551 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa)) ceased to be in
effect. The provision described certain conditions under which a drug
or medical device manufacturer could disseminate medical and scientific
information discussing unapproved uses of approved drugs and cleared or
approved medical devices to healthcare professionals and certain
entities (including pharmacy benefits managers, health insurance
issuers, group health plans, and Federal or State governmental
agencies). Section 401 of FDAMA provided that, if the described
conditions were met, dissemination of such journal articles or
reference publications would not be considered as evidence of the
manufacturer's intent that the product be used for an unapproved new
use. FDA-implementing regulations were codified at 21 CFR part 99. In
light of the sunset of section 401 of FDAMA and in recognition of the
public health value to healthcare professionals of receiving scientific
and medical information, FDA determined that its current views and
recommendations concerning ``Good Reprint Practices'' for the
dissemination of medical journal articles and medical or scientific
reference publications on unapproved uses of drugs and medical devices
were important. The sunset of the statutory provision eliminated the
authority of FDA to require submission of articles for the agency's
review before dissemination by the manufacturers in instances where the
manufacturer chose to disseminate information under these provisions.
In the absence of that ability to require such submissions and the fact
that the implementing regulations are no longer applicable, the agency
determined that guidance to manufacturers was appropriate because the
agency no longer reviews individual articles.
With this guidance, FDA is providing its current views on the
dissemination of medical journal articles and medical or scientific
reference publications on unapproved uses of approved drugs and
approved or cleared medical devices to healthcare professionals and
healthcare entities. FDA's legal authority to determine whether certain
distributions of medical or scientific information constitutes
promotion of an unapproved ``new use,'' or whether such activities
cause a product to be misbranded or adulterated has not changed.
Some of the changes made to the guidance based on comments
received, and on FDA's own initiative, include a specific reference
encouraging manufacturers to seek approvals and clearance for new
indications and intended uses for medical products. FDA recognizes the
value of new indications and uses for approved products and wants these
to be studied so that patients and healthcare professionals receive
safe and effective treatments. Many comments suggested that FDA
continue to require pre-submission of the articles and suggested other
mandatory review practices. However, given the sunset of section 401 of
FDAMA these were not within FDA's authority and thus outside the scope
of this guidance. Section IV of the guidance clarifies a number of
bullet points to address comments expressing confusion as to some of
the terms and practices expressed. Additional information was provided
to distinguish the dissemination of these types of articles from other
industry practices.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on the dissemination of medical journal
articles and medical or scientific reference publications on unapproved
uses of approved drugs and approved or cleared medical devices to
healthcare professionals and healthcare entities. 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 applicable statutes and regulations.
II. Comments
Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. Submit a single copy of
[[Page 1695]]
electronic comments or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. A copy of the guidance and received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/oc/op/goodreprint.html or https://
www.regulations.gov.
Dated: January 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-452 Filed 1-12-09; 8:45 am]
BILLING CODE 4160-01-S
