Client Alert: 2012 OPDP Warning and Untitled Letters

2222012 OPDP Warning and Untitled Letters
Date with
Hyperlink Drug and Indications Referenced
to Letter
in Letter
03-14-2012 Avonex®
For the treatment of patients with
relapsing forms of multiple
sclerosis to slow the accumulation
of physical disability and decrease
the frequency of clinical
exacerbations.
Boxed
Warning
No
Form of
Communication
Direct-to-
Consumer
Webpages
Summary of Alleged Violations
Overstatement of Efficacy:
o Webpage implies that Avonex will enable 80% of patients with relapsing
forms of multiple sclerosis to stay active and able for 10 years when
clinical studies in the PI only support efficacy for up to 3 years. The openlabel
follow-up study cited on the webpage is not substantial support.
o Statement that FDA-approved labeling includes up to 3 years of clinical
data does not mitigate the misleading impression.
o Presentation implies that Avonex is effective for each of the individual
functional areas of the Expanded Disability Status Scale (EDSS) listed on
the webpage, but the study in the PI evaluated impact on total EDSS score,
not each individual functional area.
Omission of Material Information/Unsubstantiated Superiority
Presentation:
o Webpage implies that Avonex is superior to other multiple sclerosis drugs
based on the selected attributes presented in the webpage that are
consistent with the products’ PIs, but the page fails to present information
about other attributes associated with the drugs, such as contraindications,
serious warnings and precautions, and laboratory test monitoring.
o Some safety information for Avonex is presented on the webpage, but
inclusion of the information in small font at the bottom of the page does
not mitigate the misleading impression.
03-30-2012 Firmagon®
For treatment of patients with
advanced prostate cancer.
No iPad Sales Aid Unapproved New Use:
o Aid suggests new intended uses for Firmagon as a neojuvant therapy
before local treatment and as treatment for patients with a rising prostate
specific antigen (PSA). Firmagon has a general indication for treatment of
advanced prostate cancer, but it has not been approved or evaluated by
FDA as a neojuvant therapy or as a treatment for rising PSA.
Overstatement of Efficacy:
o Claims suggest that the velocity of PSA reduction is clinically meaningful
for patients with advanced prostate cancer, which is not supported by
substantial evidence or experience.
o Statement that PSA results should be interpreted with caution and that
there is no evidence to show that rapidity of PSA decline is related to
clinical benefit does not mitigate the misleading impression.
o Claims suggest that the reduction in risk of PSA recurrence is clinically
meaningful or associated with improved disease control or survival when
this has not been demonstrated. Also, PSA levels were monitored as a
secondary endpoint in the pivotal study and the referenced study was an
6