Promotion of FDA-Regulated Medical Products 6
of Medical Policy (OMP) in FDA’s Center for Drug
Evaluation and Research (CDER). OPDP is distinct
from the Office of New Drugs (OND), the FDA office
containing the divisions responsible for reviewing and
approving new prescription drugs and therapeutic
biologics, including drug labeling.
Before September 2011, OPDP was the Division
of Drug Marketing, Advertising, and Communications
(DDMAC). Despite the structural and name changes,
the office’s mission has remained the same:
To protect the public health by assuring prescrip-
tion drug information is truthful, balanced, and
accurately communicated. This is accomplished
through a comprehensive surveillance, enforce-
ment, and education program, and by fostering
better communication of labeling and promotional
information to both healthcare professionals and
consumers.6
OPDP’s mission of protecting public health is executed
via multiple actions beyond monitoring industry pro-
motional activities and issuing letters if violations are
observed. Since 2011, OPDP has prioritized its efforts
to promote “voluntary compliance” by encouraging
the submission of materials for advisory comment and
actively developing guidance documents for industry,
often based on the results of its own internal social
science research activities (see Sidebar 1-2).
OPDP’s Labeling Review Activities
A set of OPDP employees is primarily responsible for
reviewing promotional materials created by pharmaceu-
tical manufacturers. The majority of these promotional
materials are submitted to OPDP by manufacturers for
mandatory review “at the time of initial dissemination
of the labeling and at the time of initial publication of
the advertisement for a prescription drug product.”7 A
completed Form FDA 2253 must accompany all man-
datory submissions to OPDP. Manufacturers also may
voluntarily submit draft promotional materials8 during
the launch phase (the first 120 days an FDA-approved
drug or therapeutic biologic is marketed to the public),
except direct-to-consumer (DTC) television advertise-
ments, which may be submitted to OPDP for advisory
comments at any time.9
OPDP accepts and, in fact, encourages electronic
submission of materials over the internet through FDA’s
electronic Common Technical Document (eCTD)
format. Although OPDP currently accepts both hard
copy and electronic versions of promotional materials,
the draft guidance, Providing Regulatory Submissions
in Electronic and Non-Electronic Format—Promotional
Labeling and Advertising Materials for Human
Prescription Drugs, states that approximately two years
after the final version of the guidance is published,
eCTD will be the required format for promotional
labeling submissions.10 See the draft guidance for addi-
tional information on the submission process.
Launch Materials Advisory Comments
OPDP will review draft materials submitted on a volun-
tary basis if requested by a manufacturer, provided the
manufacturer has not previously used or published the
same or similar promotional claims. Due to OPDP time
and resource limitations, advisory comment requests are
used most often for materials with the greatest visibility:
core launch materials and television advertising.
FDA defines “launch materials” as draft promo-
tional materials associated with the approval of a new
drug, indication, delivery system, formulation or route
of administration.11 Launch materials are generally
a high OPDP priority based on a common-sense
principle that the first impression is the most lasting.
If a misleading message is conveyed when a drug is
first introduced into the market, it is hard to correct.
Accordingly, OPDP monitors launches closely and
encourages the submission of launch materials for com-
ment before dissemination.
FDA guidance provides the following advice about
submitting launch materials for advisor comments:12
• “Launch” refers to the first 120 days an FDA-
approved product is marketed to the public
(note: this is not the date of FDA approval).
Materials intended to be used after this period
are not considered launch materials.
• Only “core” launch materials should be sub-
mitted for advisory comments:
Sidebar 1-2. Best Practices for Interacting With
OPDP Reviewers
• Foster a flexible, collaborative and non-adver-
sarial relationship.
• Set a goal for each interaction.
• Be organized and prepared.
• Listen carefully to what FDA actually says.
• Take detailed notes (consider assigning a
single person to be the note taker).
• If the interaction is based on a prior commu-
nication (advisory comments or enforcement
action), know the issues and the company’s
position.
• Follow up any requests in a timely manner.
• The company should not miss or show up late
to a scheduled meeting.
of Medical Policy (OMP) in FDA’s Center for Drug
Evaluation and Research (CDER). OPDP is distinct
from the Office of New Drugs (OND), the FDA office
containing the divisions responsible for reviewing and
approving new prescription drugs and therapeutic
biologics, including drug labeling.
Before September 2011, OPDP was the Division
of Drug Marketing, Advertising, and Communications
(DDMAC). Despite the structural and name changes,
the office’s mission has remained the same:
To protect the public health by assuring prescrip-
tion drug information is truthful, balanced, and
accurately communicated. This is accomplished
through a comprehensive surveillance, enforce-
ment, and education program, and by fostering
better communication of labeling and promotional
information to both healthcare professionals and
consumers.6
OPDP’s mission of protecting public health is executed
via multiple actions beyond monitoring industry pro-
motional activities and issuing letters if violations are
observed. Since 2011, OPDP has prioritized its efforts
to promote “voluntary compliance” by encouraging
the submission of materials for advisory comment and
actively developing guidance documents for industry,
often based on the results of its own internal social
science research activities (see Sidebar 1-2).
OPDP’s Labeling Review Activities
A set of OPDP employees is primarily responsible for
reviewing promotional materials created by pharmaceu-
tical manufacturers. The majority of these promotional
materials are submitted to OPDP by manufacturers for
mandatory review “at the time of initial dissemination
of the labeling and at the time of initial publication of
the advertisement for a prescription drug product.”7 A
completed Form FDA 2253 must accompany all man-
datory submissions to OPDP. Manufacturers also may
voluntarily submit draft promotional materials8 during
the launch phase (the first 120 days an FDA-approved
drug or therapeutic biologic is marketed to the public),
except direct-to-consumer (DTC) television advertise-
ments, which may be submitted to OPDP for advisory
comments at any time.9
OPDP accepts and, in fact, encourages electronic
submission of materials over the internet through FDA’s
electronic Common Technical Document (eCTD)
format. Although OPDP currently accepts both hard
copy and electronic versions of promotional materials,
the draft guidance, Providing Regulatory Submissions
in Electronic and Non-Electronic Format—Promotional
Labeling and Advertising Materials for Human
Prescription Drugs, states that approximately two years
after the final version of the guidance is published,
eCTD will be the required format for promotional
labeling submissions.10 See the draft guidance for addi-
tional information on the submission process.
Launch Materials Advisory Comments
OPDP will review draft materials submitted on a volun-
tary basis if requested by a manufacturer, provided the
manufacturer has not previously used or published the
same or similar promotional claims. Due to OPDP time
and resource limitations, advisory comment requests are
used most often for materials with the greatest visibility:
core launch materials and television advertising.
FDA defines “launch materials” as draft promo-
tional materials associated with the approval of a new
drug, indication, delivery system, formulation or route
of administration.11 Launch materials are generally
a high OPDP priority based on a common-sense
principle that the first impression is the most lasting.
If a misleading message is conveyed when a drug is
first introduced into the market, it is hard to correct.
Accordingly, OPDP monitors launches closely and
encourages the submission of launch materials for com-
ment before dissemination.
FDA guidance provides the following advice about
submitting launch materials for advisor comments:12
• “Launch” refers to the first 120 days an FDA-
approved product is marketed to the public
(note: this is not the date of FDA approval).
Materials intended to be used after this period
are not considered launch materials.
• Only “core” launch materials should be sub-
mitted for advisory comments:
Sidebar 1-2. Best Practices for Interacting With
OPDP Reviewers
• Foster a flexible, collaborative and non-adver-
sarial relationship.
• Set a goal for each interaction.
• Be organized and prepared.
• Listen carefully to what FDA actually says.
• Take detailed notes (consider assigning a
single person to be the note taker).
• If the interaction is based on a prior commu-
nication (advisory comments or enforcement
action), know the issues and the company’s
position.
• Follow up any requests in a timely manner.
• The company should not miss or show up late
to a scheduled meeting.