Promotion of FDA-Regulated Medical Products 7
o one comprehensive professional labeling
piece (e.g., sales aid, visual aid or detail
aid or exhibit panel if there is a major
conference within the launch phase)
limited to 12 or fewer pages
o one professional advertisement (e.g.,
journal ad) limited to four or fewer pages,
not including the package insert (PI) or
brief summary
o one comprehensive DTC labeling piece
(e.g., patient brochure) limited to 12 or
fewer pages
o one DTC advertisement (e.g., magazine
advertisement) limited to four or fewer
pages, not including the PI or brief
summary
o professional and DTC product websites
(limited to 12 printed PDF pages each)
or electronic sales aids that are derivatives
of the comprehensive labeling piece, if
one was submitted
• Other promotional materials such as slide kits,
reprints and monographs are not considered
core launch materials. They are a lower prior-
ity for OPDP reviewers and are not subject to
the 45-day goal timeline.
• As with any request for advisory comments,
the manufacturer should not use the claims
in the promotional materials or similar claims
while the review is pending.
OPDP tries to provide comments within 45 busi-
ness days of submission, but additional time may be
necessary if complex issues arise based on the content.13
Importantly, OPDP’s goal timeline of 45 days does not
include any time spent consulting with the medical
reviewers in the Office of New Drugs (OND) who
are responsible for NDA and supplement reviews and
approvals. OPDP is most likely to require a medical
consult if claims in the promotional materials cannot be
directly referenced to the PI. Depending on their scope,
extra-label claims may significantly delay the receipt
of OPDP comments. Manufacturers, therefore, must
weigh the benefits of submitting these additional claims
in their launch materials versus the risk of an OPDP
review extending beyond 45 days.
OPDP provides metrics on the volume and
percentage of completed launch reviews on its FDA-
TRACK CDER Dashboard webpage on FDA’s
website.14 In fiscal years 2017 and 2018, OPDP gener-
ally reviewed between 50% and 100% of core launch
materials within the 45-day timeframe.15
The draft guidance, Providing Regulatory
Submissions in Electronic and Non-Electronic Format—
Promotional Labeling and Advertising Materials for
Human Prescription Drugs, also provides information on
how to submit advisory comment requests on television
advertisements and other non-launch materials.16 In
general, FDA asks that a request for advisory comments
on all promotional materials (including television
advertisements) be submitted via an eCTD with
annotated and clean versions of the proposed materials,
the current FDA-approved PI, as well as a complete set
of annotated references and annotated FDA-approved
patient labeling (if applicable). A separate cover letter
should not be submitted, but the body of the corre-
spondence should include the specific information
described in Section VI.E of the guidance, such as: a list
of all promotional materials included, whether submis-
sion is for “launch” or “non-launch,” whether materials
are “core” or “non-core” and whether the promotional
material is a television ad.17
Atypical Review Processes
In certain circumstances, OPDP may require
the submission of promotional materials prior to
dissemination.
With the passage of the Food and Drug
Administration Amendments Act of 2007 (FDAAA),
FDA was granted the authority to “require the submis-
sion of any television advertisement for a drug…not
later than 45 days before dissemination of the televi-
sion advertisement.” According to its draft guidance
issued in March 2012, OPDP plans to extend that
pre-dissemination requirement to a significant number
of television ads.18 This issue is discussed further in
Chapter 5.
FDA also has a longstanding but rarely exercised
authority to require the approval of promotional mate-
rials before dissemination in cases where significant new
safety information arises regarding “fatalities or serious
damage” associated with use of a marketed drug.19
OPDP uses a diverse array of tactics to survey drug
manufacturers’ promotional materials. One common
method is for OPDP reviewers to attend major medical
meetings and pharmaceutical conventions, visiting pro-
motional booths to observe exhibitors’ practices.
Accelerated Approval/Subpart H Products
A major drug category requiring submission of
materials prior to dissemination is drugs under the
“accelerated approval” provisions of the FD&C Act and
its implementing regulations.
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
o one comprehensive professional labeling
piece (e.g., sales aid, visual aid or detail
aid or exhibit panel if there is a major
conference within the launch phase)
limited to 12 or fewer pages
o one professional advertisement (e.g.,
journal ad) limited to four or fewer pages,
not including the package insert (PI) or
brief summary
o one comprehensive DTC labeling piece
(e.g., patient brochure) limited to 12 or
fewer pages
o one DTC advertisement (e.g., magazine
advertisement) limited to four or fewer
pages, not including the PI or brief
summary
o professional and DTC product websites
(limited to 12 printed PDF pages each)
or electronic sales aids that are derivatives
of the comprehensive labeling piece, if
one was submitted
• Other promotional materials such as slide kits,
reprints and monographs are not considered
core launch materials. They are a lower prior-
ity for OPDP reviewers and are not subject to
the 45-day goal timeline.
• As with any request for advisory comments,
the manufacturer should not use the claims
in the promotional materials or similar claims
while the review is pending.
OPDP tries to provide comments within 45 busi-
ness days of submission, but additional time may be
necessary if complex issues arise based on the content.13
Importantly, OPDP’s goal timeline of 45 days does not
include any time spent consulting with the medical
reviewers in the Office of New Drugs (OND) who
are responsible for NDA and supplement reviews and
approvals. OPDP is most likely to require a medical
consult if claims in the promotional materials cannot be
directly referenced to the PI. Depending on their scope,
extra-label claims may significantly delay the receipt
of OPDP comments. Manufacturers, therefore, must
weigh the benefits of submitting these additional claims
in their launch materials versus the risk of an OPDP
review extending beyond 45 days.
OPDP provides metrics on the volume and
percentage of completed launch reviews on its FDA-
TRACK CDER Dashboard webpage on FDA’s
website.14 In fiscal years 2017 and 2018, OPDP gener-
ally reviewed between 50% and 100% of core launch
materials within the 45-day timeframe.15
The draft guidance, Providing Regulatory
Submissions in Electronic and Non-Electronic Format—
Promotional Labeling and Advertising Materials for
Human Prescription Drugs, also provides information on
how to submit advisory comment requests on television
advertisements and other non-launch materials.16 In
general, FDA asks that a request for advisory comments
on all promotional materials (including television
advertisements) be submitted via an eCTD with
annotated and clean versions of the proposed materials,
the current FDA-approved PI, as well as a complete set
of annotated references and annotated FDA-approved
patient labeling (if applicable). A separate cover letter
should not be submitted, but the body of the corre-
spondence should include the specific information
described in Section VI.E of the guidance, such as: a list
of all promotional materials included, whether submis-
sion is for “launch” or “non-launch,” whether materials
are “core” or “non-core” and whether the promotional
material is a television ad.17
Atypical Review Processes
In certain circumstances, OPDP may require
the submission of promotional materials prior to
dissemination.
With the passage of the Food and Drug
Administration Amendments Act of 2007 (FDAAA),
FDA was granted the authority to “require the submis-
sion of any television advertisement for a drug…not
later than 45 days before dissemination of the televi-
sion advertisement.” According to its draft guidance
issued in March 2012, OPDP plans to extend that
pre-dissemination requirement to a significant number
of television ads.18 This issue is discussed further in
Chapter 5.
FDA also has a longstanding but rarely exercised
authority to require the approval of promotional mate-
rials before dissemination in cases where significant new
safety information arises regarding “fatalities or serious
damage” associated with use of a marketed drug.19
OPDP uses a diverse array of tactics to survey drug
manufacturers’ promotional materials. One common
method is for OPDP reviewers to attend major medical
meetings and pharmaceutical conventions, visiting pro-
motional booths to observe exhibitors’ practices.
Accelerated Approval/Subpart H Products
A major drug category requiring submission of
materials prior to dissemination is drugs under the
“accelerated approval” provisions of the FD&C Act and
its implementing regulations.
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6