Client Alert: 2012 OPDP Warning and Untitled Letters

2222012 OPDP Warning and Untitled Letters
Date with
Hyperlink
to Letter
Drug and Indications Referenced
in Letter
Boxed
Warning
Form of
Communication
Summary of Alleged Violations
o Disclaimers stating that case study results “are not necessarily
representative and may vary by patient” do not mitigate the misleading
impression of the claims and presentations.
Unsubstantiated Efficacy Claims:
o Claim is an accurate summary of a patient’s experience, but implies that
Gleevec is effective at treating melana without support by substantial
evidence.
02-28-2012 Saphris®
As a monotherapy, for the acute
treatment of manic or mixed
episodes associated with bipolar I
disorder; as an adjunctive therapy
with lithium or valproate, for the
acute treatment of manic or mixed
episodes associated with bipolar I
disorder.
Yes Oral Statements † Promotion of Unapproved Uses:
o Statement made during an oral presentation to a group of healthcare
professionals implies that Saphris is safe and effective for use as an
adjunctive treatment for major depressive disorder when Saphris is not
indicated for this use. The statements suggest a new intended use for
Saphris for which the Product Labeling (PI) lacks adequate directions for
use.
03-06-2012 Atralin
For topical treatment of acne
vulgaris.
No
Direct-to-
Consumer
Website,
Professional
Detail Aid
Unsubstantiated Superiority Claims/Unsubstantiated Claims:
o Claims and presentations in the aid suggest that Atralin’s formulation and
purported greater delivery to the dermis result in superior safety and
efficacy compared to other tretinoin products and that Atralin is more
tolerable than products of similar strength, but FDA is unaware of
substantial evidence for the claims.
o FDA is unaware of evidence demonstrating that Atralin gel has
pharmacological activity in the dermis, and there are no data to support the
notion that in vitro percutaneous absorption data predict or correlate with
comparative clinical efficacy because disease state might affect drug
penetration and bioavailability and the in vitro percutaneous absorption
method is not adequate for assessing comparative in vivo levels clinically
at the dermis for different formulations.
o A small footnote indicating that the clinical significance of in vitro data is
unknown and that differences were not statistically significant does not
correct the misleading impression.
o Claims in the website and aid suggest that Atralin is clinically superior to
other tretinoin formulations because individual ingredients in Atralin’s
vehicle are purported to provide specific clinical benefits such as
moisturizing skin, but this has not been demonstrated in adequate and wellcontrolled
head-to-head clinical trials comparing appropriate doses and
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