Promotion of FDA-Regulated Medical Products 8
Accelerated approval is a regulatory mechanism by
which FDA may approve certain new drugs for serious
and life-threatening diseases or conditions.20 The associ-
ated regulations are found in 21 CFR Part 314, Subpart
H, and products approved under this mechanism often
are referred to as “Subpart H” drugs. Unlike a stan-
dard NDA approval, which requires demonstration of
substantial evidence of clinical benefit, an accelerated
approval can be based on an effect on a surrogate
endpoint. Since the product’s benefit will not have been
fully elucidated at the time of approval, FDA requires
Subpart H drug manufacturers to conduct additional
studies postapproval.
The dissemination of promotional materials for
accelerated approval products is restricted in certain
ways.21 First, all promotional materials intended for
use in the first 120 days following NDA approval must
be submitted for OPDP review during the preap-
proval period. In addition, after this initial four-month
postapproval period, all promotional materials must
be submitted to FDA at least 30 days prior to first use.
After a certain period, FDA may determine that these
submission requirements are no longer necessary and
will notify the manufacturer in writing.22
Manufacturers of Subpart H drugs should follow
the draft guidance, Providing Regulatory Submissions
in Electronic and Non-Electronic Format—Promotional
Labeling and Advertising Materials for Human
Prescription Drugs, when submitting proposed promo-
tional materials.23
Public Complaints and the Bad Ad Program
OPDP also regularly receives complaints from the pub-
lic and from manufacturers about their competitors.
OPDP has requested in public meetings that individ-
uals submit complaints identifying the drug, the issue
and the promotional piece in as much detail as possible,
including an index if multiple pieces are referenced.24
FDA’s website also includes extensive educational
information on prescription drug advertising, and asks
consumers who encounter inaccurate or misleading
advertisements to contact OPDP.25
While OPDP always accepted complaints from
healthcare professionals and, in some cases, issued
Untitled or Warning Letters based on those complaints,
in May 2010, it introduced a new program to educate
prescribers on how to identify and report misleading
prescription drug promotion. The Truthful Prescription
Drug Advertising and Promotion Program (also known
as the “Bad Ad” program) was launched via presen-
tations to prescribers and distribution of educational
brochures on misleading promotion at 15 medical
conferences in 2010, as well as an informational video
Sidebar 1-3. Enforcement Example: YAZ 10/2008
On 3 October 2008, OPDP sent a Warning Letter to
Bayer Pharmaceuticals for two television advertise-
ments for the oral contraceptive, YAZ (drospirenone
and ethinyl estradiol).a At the time, YAZ was approved
not only as an oral contraceptive, but also for the
treatment of premenstrual dysphoric disorder (PMDD)
and moderate acne in patients who were seeking birth
control.
The Warning Letter stated the ads:
• misleadingly broadened the indication for the
product by suggesting the drug was approved
to treat PMS (as opposed to the more seri-
ous and less common condition, PMDD) and
suggesting the drug was approved to treat
all forms of acne (as opposed to acne of
moderate severity only)
• overstated efficacy by suggesting, through
visuals, that the drug will result in a com-
plete resolution of PMDD symptoms and
acne (when the drug had not been demon-
strated to do so)
• minimized the risks associated with the drug
by presenting distracting visuals and music
in the section of the ad dedicated to risk
information
Moreover, the Warning Letter requested that Bayer
submit a plan for corrective action:
“Because the violations described above are
serious, we request, further, that your [response
to this letter] include a comprehensive plan of
action to disseminate truthful, non-misleading,
and complete corrective messages about the
issues discussed in this letter to the audience(s)
that received the violative promotional materials.”
The result of this request was a new, six-month
corrective TV campaign, aimed at the same audience
that had seen the original ads. During the corrective TV
ad, a young woman similar to those appearing in the
original ad and in a similar location speaks directly into
the camera:
“You may have seen some YAZ commercials
recently that were not clear. The FDA wants us to
correct a few points in those ads. YAZ is approved
for pregnancy prevention. If you choose the pill for
contraception, you should know that YAZ is for the
treatment of premenstrual dysphoric disorder (or
PMDD) and moderate acne, not for the treatment
of PMS or mild acne. Unlike PMS, symptoms of
PMDD are severe enough to interfere with your
life. YAZ has helped many women reduce their
PMDD symptoms and moderate acne you should
know that it may not work for everyone...”
a See also “A Birth Control Pill That Promised
Too Much,” The New York Times, 10 February
2009. The New York Times website. www.nytimes.
com/2009/02/11/business/11pill.html. Accessed 3
September 2018.
Accelerated approval is a regulatory mechanism by
which FDA may approve certain new drugs for serious
and life-threatening diseases or conditions.20 The associ-
ated regulations are found in 21 CFR Part 314, Subpart
H, and products approved under this mechanism often
are referred to as “Subpart H” drugs. Unlike a stan-
dard NDA approval, which requires demonstration of
substantial evidence of clinical benefit, an accelerated
approval can be based on an effect on a surrogate
endpoint. Since the product’s benefit will not have been
fully elucidated at the time of approval, FDA requires
Subpart H drug manufacturers to conduct additional
studies postapproval.
The dissemination of promotional materials for
accelerated approval products is restricted in certain
ways.21 First, all promotional materials intended for
use in the first 120 days following NDA approval must
be submitted for OPDP review during the preap-
proval period. In addition, after this initial four-month
postapproval period, all promotional materials must
be submitted to FDA at least 30 days prior to first use.
After a certain period, FDA may determine that these
submission requirements are no longer necessary and
will notify the manufacturer in writing.22
Manufacturers of Subpart H drugs should follow
the draft guidance, Providing Regulatory Submissions
in Electronic and Non-Electronic Format—Promotional
Labeling and Advertising Materials for Human
Prescription Drugs, when submitting proposed promo-
tional materials.23
Public Complaints and the Bad Ad Program
OPDP also regularly receives complaints from the pub-
lic and from manufacturers about their competitors.
OPDP has requested in public meetings that individ-
uals submit complaints identifying the drug, the issue
and the promotional piece in as much detail as possible,
including an index if multiple pieces are referenced.24
FDA’s website also includes extensive educational
information on prescription drug advertising, and asks
consumers who encounter inaccurate or misleading
advertisements to contact OPDP.25
While OPDP always accepted complaints from
healthcare professionals and, in some cases, issued
Untitled or Warning Letters based on those complaints,
in May 2010, it introduced a new program to educate
prescribers on how to identify and report misleading
prescription drug promotion. The Truthful Prescription
Drug Advertising and Promotion Program (also known
as the “Bad Ad” program) was launched via presen-
tations to prescribers and distribution of educational
brochures on misleading promotion at 15 medical
conferences in 2010, as well as an informational video
Sidebar 1-3. Enforcement Example: YAZ 10/2008
On 3 October 2008, OPDP sent a Warning Letter to
Bayer Pharmaceuticals for two television advertise-
ments for the oral contraceptive, YAZ (drospirenone
and ethinyl estradiol).a At the time, YAZ was approved
not only as an oral contraceptive, but also for the
treatment of premenstrual dysphoric disorder (PMDD)
and moderate acne in patients who were seeking birth
control.
The Warning Letter stated the ads:
• misleadingly broadened the indication for the
product by suggesting the drug was approved
to treat PMS (as opposed to the more seri-
ous and less common condition, PMDD) and
suggesting the drug was approved to treat
all forms of acne (as opposed to acne of
moderate severity only)
• overstated efficacy by suggesting, through
visuals, that the drug will result in a com-
plete resolution of PMDD symptoms and
acne (when the drug had not been demon-
strated to do so)
• minimized the risks associated with the drug
by presenting distracting visuals and music
in the section of the ad dedicated to risk
information
Moreover, the Warning Letter requested that Bayer
submit a plan for corrective action:
“Because the violations described above are
serious, we request, further, that your [response
to this letter] include a comprehensive plan of
action to disseminate truthful, non-misleading,
and complete corrective messages about the
issues discussed in this letter to the audience(s)
that received the violative promotional materials.”
The result of this request was a new, six-month
corrective TV campaign, aimed at the same audience
that had seen the original ads. During the corrective TV
ad, a young woman similar to those appearing in the
original ad and in a similar location speaks directly into
the camera:
“You may have seen some YAZ commercials
recently that were not clear. The FDA wants us to
correct a few points in those ads. YAZ is approved
for pregnancy prevention. If you choose the pill for
contraception, you should know that YAZ is for the
treatment of premenstrual dysphoric disorder (or
PMDD) and moderate acne, not for the treatment
of PMS or mild acne. Unlike PMS, symptoms of
PMDD are severe enough to interfere with your
life. YAZ has helped many women reduce their
PMDD symptoms and moderate acne you should
know that it may not work for everyone...”
a See also “A Birth Control Pill That Promised
Too Much,” The New York Times, 10 February
2009. The New York Times website. www.nytimes.
com/2009/02/11/business/11pill.html. Accessed 3
September 2018.