Transcript ppt - PharmedOut

Misleading Ads
& FDA Warnings
©PharmedOut 2013
Georgetown University Medical Center
Part of the Drug Ads Exercise Presentation Series
Disclaimer: Intellectual Property
In this presentation, you will notice that we use images of
many registered trademarks, many branded drug trade
names, and many copyrighted advertisements -- from many
different business concerns -- including drug companies,
marketing consultants and medical journals. All of the
intellectual property contained therein is, and remains, the
exclusive intellectual property of the respective owners.
Each image is used for the purpose of educational, and
critical, analysis. No endorsement of any position articulated
in this presentation should be inferred from the appearance
of any brand, trademark, trade name or ad copy herein. This
presentation has been designed with the intent to qualify
for the doctrine of "fair use" -- as to these pieces of
intellectual property -- under the law of the United States.
FDA Terms Used in Letters*
1. Unsubstantiated
Superiority/Overstatement of Efficacy
Claims
2. Omission of Risk Information
3. Minimization of Risk Information
4. Broadening of Indication
5. Use of Outdated Product Labeling
*The following explanations of FDA terms have been paraphrased.
Unsubstantiated Superiority/Overstatement
of Efficacy Claims
An implication is made that a drug is better or
more effective without supporting scientific
evidence
Boniva
Osteoporosis Treatment
Print Ad
Boniva: Overstatement of Efficacy
Claim: “Studies show, after a year on Boniva, 9 out of 10
women stopped and reversed their bone loss.”
FDA Comments About Print Ad:
• The clinical study that served for the basis of approval…
was designed to assess the percent change from
baseline in lumbar BMD [bone mineral density] at 1
year.
• This claim is based on a… per-protocol post-hoc analysis
of a secondary efficacy endpoint… at the lumbar spine,
total hip, trochanter, and femoral neck… that the
clinical study was not adequately designed to evaluate.
Omission of Risk Information
The exclusion of important risks and
consequences that may occur with approved
use of a drug
Exforge (amlodipine and valsartan)
Antihypertensive
Patient Brochure
Exforge: Omission of Risk Information
FDA Comments About Patient Brochure:
• The brochure fails to reveal Warnings and
Precautions regarding hepatic impairment
and interactions with potassium sparing
diuretics, potassium supplements, or salt
substitutes containing potassium.
Minimization of Risk Information
While risk information is presented, it is
difficult to find, see, or read in comparison to
information on effectiveness
Gelnique
(oxybutynin
chloride)
Overactive Bladder
Treatment
Efficacy Claims
Risk Info
Restroom Stall Poster at Conference
Gelnique:
Minimization of Risk Information
Claim: “Smart gel technology is her weapon…”
FDA Comments About Restroom Stall Poster:
•
The stall cling… presents efficacy claims and presentations in large, bold,
and colorful font and graphics… surrounded by a significant amount of
space.
•
In contrast, the risk information is relegated to the bottom… and written in
white text on a purple background in an extremely small font size and in
single-spaced paragraph format, making this information very difficult to
read.
•
This presentation… fails to convey this important risk information with a
prominence and readability… comparable to the claims of effectiveness. In
addition, the most common adverse events are presented before more
serious risks.
Broadening of Indication
The suggestion that a drug is more effective
and/or capable of treatment outcomes in
more conditions or patients than scientific
evidence supports.
AzaSite
(azithromycin)
Ocular Antibacterial
Journal Ad
AzaSite: Broadening of Indication
Claim: “AzaSite can restore a healthy ocular surface.”
FDA Comments About Journal Ad:
• AzaSite is indicated only for the treatment of bacterial
conjunctivitis.
• The… presentation… suggests that AzaSite is indicated to
treat any condition that causes ocular surface damage,
which could include viral conjunctivitis (pinkeye), chemical
injury, blepharitis, dry eye disease, and ocular rosacea, when
such has not been demonstrated by substantial evidence or
substantial clinical experience.
Use of Outdated Product Labeling
Distribution of outdated information about a
drug.
Uroxatral (alfuzosin)
Treatment for Symptoms of Benign Prostatic Hyperplasia
Voucher Tent Card
Package Insert (PI)
Uroxatral:
Use of Outdated Product Labeling
FDA Comments about Tent Card:
• The most current version of the FDAapproved PI as of February 24, 2009 was the
July 23, 2008 version, not the April 2007
version.
Other examples
Copaxone (glatiramer acetate)
Treatment to Reduce Frequency of Relapses in
Relapsing-Remitting Multiple Sclerosis
Professional Exhibit Panel at
American Academy of Neurology Conference
Copaxone: Overstatement of Efficacy
Claim: “20 years of proven safety.”
FDA Comments About Exhibit Panel:
• Long term… safety and efficacy… has not
been demonstrated by substantial evidence
or substantial clinical experience. The
CLINICAL STUDIES section of the PI only
includes data for up to three years in
duration.
Copaxone: Omission of Information
Claim: “Copaxone is NOT associated with
immunosuppression/serious infections, decrease in
pulmonary function, or anaphylaxis.”
FDA Comments About Exhibit Panel:
• The table suggests that Copaxone is not associated
with immunosuppression/infections, pulmonary
function, and anaphylaxis/hypersensitivity, when this is
not the case.
• The table fails to present the Warnings for chest pain,
skin necrosis and… effects… on immune response.
“Running, Swimming, and
Biking Against MS”
“Taking on MS, One
Step at a Time”
Copaxone: Broadening of Indication
FDA Comments About Exhibit Panel:
• Copaxone is indicated for reduction of the
frequency of relapses in patients with RRMS
[relapse-remitting multiple sclerosis].
• However… the webpages make claims that
misleadingly broaden the indication for Copaxone,
such as, “Running, Swimming and Biking Against
Multiple Sclerosis”… and “Taking on Multiple
Sclerosis, One Step at a Time."
Angiomax (bivalirudin)
Anticoagulant
Professional Booth Panel
Angiomax:
Omission of Risk Information
FDA Comments About Booth Panel:
• The booth panel fails to convey that the
most common adverse event associated
with Angiomax was bleeding, which was
experienced in 28% of patients.
References
Angiomax: Unsubstantiated
Superiority Claims in References
FDA Comments About Booth Panel:
• “The Rich, et al.2 study does not constitute
substantial evidence to support claims and
presentations implying that Angiomax is clinically
superior to heparin ‘throughout the risk spectrum.’”
• The Acuity PCI study failed to show non-inferiority of
Angiomax to enoxaparin or UFH when analyzed for
the endpoint of death or MI at 30 days.
FDA's "Bad Ad" Program
• Launched in 2010
• Designed to educate healthcare providers about the
role they can play in helping make sure that
prescription drug advertising is truthful
• Provides an easy way to report misleading
information to the agency:
• E-mail [email protected] or call 855-RX-BADAD.
• To learn more, go to Fda.gov/badad.
• Promotes rational prescribing.
• Provides Grand Rounds, seminars, and free, web-based CME.
• Offers teaching tools, videos, slideshows, patient factsheets, “No
Drug Reps” certificate, and many other resources.
• Internships available!
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