Promotion of FDA-Regulated Medical Products 9
on the FDA website.26 Although FDA staff anticipated
sales representatives’ activities would be the primary
target for Bad Ad complaints, the program has, in fact,
generated letters citing a wide variety of promotional
items (see Sidebar 1-3).
OPDP Research Activities and Development
of New Policies Based on Social Science
Findings
In addition to its reviewers, OPDP has dedicated staff
and resources to develop policy and social science
research. The studies undertaken as part of this initiative
influence FDA’s development of guidance documents
and ensures such guidance is relevant to modern meth-
ods of product promotion (including presentation of
product risk information) and to consumers’ perception
and understanding of promotional materials.
Some examples of OPDP social science research
projects include:27
• Do Prescription Drug Ads Tell Consumers
Enough About Benefits and Side Effects?
Results from the Health Information National
Trends Survey, Fourth Administration
(Completed in 2015)—Using data collected
by the National Cancer Institute, FDA deter-
mined that 52% of survey respondents believe
DTC advertisements do not include enough
information about risks, and 46% believe such
advertisements do not adequately describe
product benefits.
• Effect of Promotional Offers on Consumer
Perceptions of Product Risks and Benefits
(Completed in 2016)—OPDP investigated
whether the presence of a promotional offer in
DTC advertisements affects consumers’ recall
and perceptions of drug risks and benefits, and
concluded promotional offers had no signifi-
cant impact.
• Eye Tracking Study of DTC Prescription
Drug Advertisement Viewing (Completed
in 2016)—Using eye tracking technology,
OPDP analyzed viewer perception of DTC
ads and measured the impact of visual dis-
tractions. The study found that distracting
elements during the major statement of risks
decreased attention to superimposed text
describing risk information.
• Comparative Price Information in DTC and
Professional Prescription Drug Advertisements
(Completed in 2017)—This study found a
majority of physicians pay attention to claims
comparing the prices of competitor drugs,
but far fewer recognize contextual statements
comparing the safety and efficacy of the same
products. In the presence of price claims, the
contextual statements did not affect physician
perceptions on drug interchangeability, and
thus, physicians may believe the lower-priced
drug has lower risks.
• Animation in DTC Promotion (Ongoing)—
This is a study of the effect animation in DTC
ads has on consumer perception and recall of
drug risk and benefit information.
• Character-Space-Limited Online Prescription
Drug Communications (Ongoing)—OPDP
is evaluating whether substantive risk infor-
mation in sponsored link or microblog
communications is effective, or whether
providing a link to the full product risk infor-
mation is adequate.
• Quantitative Information in DTC Television
Advertisements (Ongoing)—This is a fol-
low-up study to evaluate consumer ability to
interpret and retain relatively complicated
quantitative information of risks and benefits
in DTC ads.
Advertising and Promotional Labeling Branch (APLB)
APLB is the branch of FDA’s Center for Biologics
Evaluation and Research (CBER) that enforces labeling
regulations for biological products, such as vaccines,
blood products and gene therapy products. Its responsi-
bilities are essentially identical to those OPDP performs
for drug products. Biologics manufacturers must
submit final versions of DTC advertisements (with
a completed Form FDA 2253) to APLB for review
and approval prior to release, and APLB evaluates
complaints that manufacturers violated promotional
labeling regulations. APLB also reviews proposed
proprietary names for biologic products and offers
consultative reviews of biologic product labeling, PI,
package inserts and medication guides. APLB may issue
Warning Letters and Untitled Letters.
Center for Devices and Radiological Health (CDRH)
Unlike CDER and OPDP, which are responsible for
regulating prescription drug promotion, CDRH neither
reviews medical device promotional materials prior
to commercialization (there is no Form 2253 equiva-
lent for devices) nor provides advisory comments on
product advertisements and promotional claims. While
CDRH is charged with ensuring device manufacturers
comply with labeling requirements (i.e., 21 CFR 801),
it will take enforcement action only after noncompliant
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6
on the FDA website.26 Although FDA staff anticipated
sales representatives’ activities would be the primary
target for Bad Ad complaints, the program has, in fact,
generated letters citing a wide variety of promotional
items (see Sidebar 1-3).
OPDP Research Activities and Development
of New Policies Based on Social Science
Findings
In addition to its reviewers, OPDP has dedicated staff
and resources to develop policy and social science
research. The studies undertaken as part of this initiative
influence FDA’s development of guidance documents
and ensures such guidance is relevant to modern meth-
ods of product promotion (including presentation of
product risk information) and to consumers’ perception
and understanding of promotional materials.
Some examples of OPDP social science research
projects include:27
• Do Prescription Drug Ads Tell Consumers
Enough About Benefits and Side Effects?
Results from the Health Information National
Trends Survey, Fourth Administration
(Completed in 2015)—Using data collected
by the National Cancer Institute, FDA deter-
mined that 52% of survey respondents believe
DTC advertisements do not include enough
information about risks, and 46% believe such
advertisements do not adequately describe
product benefits.
• Effect of Promotional Offers on Consumer
Perceptions of Product Risks and Benefits
(Completed in 2016)—OPDP investigated
whether the presence of a promotional offer in
DTC advertisements affects consumers’ recall
and perceptions of drug risks and benefits, and
concluded promotional offers had no signifi-
cant impact.
• Eye Tracking Study of DTC Prescription
Drug Advertisement Viewing (Completed
in 2016)—Using eye tracking technology,
OPDP analyzed viewer perception of DTC
ads and measured the impact of visual dis-
tractions. The study found that distracting
elements during the major statement of risks
decreased attention to superimposed text
describing risk information.
• Comparative Price Information in DTC and
Professional Prescription Drug Advertisements
(Completed in 2017)—This study found a
majority of physicians pay attention to claims
comparing the prices of competitor drugs,
but far fewer recognize contextual statements
comparing the safety and efficacy of the same
products. In the presence of price claims, the
contextual statements did not affect physician
perceptions on drug interchangeability, and
thus, physicians may believe the lower-priced
drug has lower risks.
• Animation in DTC Promotion (Ongoing)—
This is a study of the effect animation in DTC
ads has on consumer perception and recall of
drug risk and benefit information.
• Character-Space-Limited Online Prescription
Drug Communications (Ongoing)—OPDP
is evaluating whether substantive risk infor-
mation in sponsored link or microblog
communications is effective, or whether
providing a link to the full product risk infor-
mation is adequate.
• Quantitative Information in DTC Television
Advertisements (Ongoing)—This is a fol-
low-up study to evaluate consumer ability to
interpret and retain relatively complicated
quantitative information of risks and benefits
in DTC ads.
Advertising and Promotional Labeling Branch (APLB)
APLB is the branch of FDA’s Center for Biologics
Evaluation and Research (CBER) that enforces labeling
regulations for biological products, such as vaccines,
blood products and gene therapy products. Its responsi-
bilities are essentially identical to those OPDP performs
for drug products. Biologics manufacturers must
submit final versions of DTC advertisements (with
a completed Form FDA 2253) to APLB for review
and approval prior to release, and APLB evaluates
complaints that manufacturers violated promotional
labeling regulations. APLB also reviews proposed
proprietary names for biologic products and offers
consultative reviews of biologic product labeling, PI,
package inserts and medication guides. APLB may issue
Warning Letters and Untitled Letters.
Center for Devices and Radiological Health (CDRH)
Unlike CDER and OPDP, which are responsible for
regulating prescription drug promotion, CDRH neither
reviews medical device promotional materials prior
to commercialization (there is no Form 2253 equiva-
lent for devices) nor provides advisory comments on
product advertisements and promotional claims. While
CDRH is charged with ensuring device manufacturers
comply with labeling requirements (i.e., 21 CFR 801),
it will take enforcement action only after noncompliant
Part
I
Part
II
Part
III
Chapter
1
Chapter
4
Chapter
7
Chapter
2
Chapter
5
Chapter
3
Chapter
6