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
relapses in patients with Relapsing-
Remitting Multiple Sclerosis
(RRMS), including patients who
have experienced a first clinical
episode and have PRI features
consistent with multiple sclerosis.
Boxed
Warning
Form of
Communication
Webpages
Summary of Alleged Violations
efficacy, but the PI only includes data for up to three years in duration.
The exhibit panels refer to open-label extension studies that do not account
for self-selection among patients who chose to participate in the studies,
and it is unclear why certain patients dropped out or were lost to follow-up.
o Claim suggests that Copaxone is superior to other RRMS therapies when
FDA is unaware of support for the claim.
Overstatement of Efficacy/Broadening of Claims:
o Webpage claims imply that Copaxone reverses patients’ disability and
enables them to lead active and regular lifestyles, which may accurately
reflect patients’ experiences, but Copaxone is not indicated for slowing,
preventing, or reversing physical disability associated with RRMS and
FDA is not aware of substantial evidence or experience supporting the
implication that treatment will result in the magnitude of effects described
in the testimonials. Highlights of other MS patients treated with Copaxone
and their subsequent athletic accomplishments are similarly misleading.
o Statement that individual results may vary does not mitigate the misleading
impressions and personal experiences of patients.
o The totality of the presentation implies that Copaxone is approved to treat
all types of MS when this is not the case.
o Webpages suggest ongoing treatment and imply that Copaxone is effective
for reducing the frequency of relapses or exacerbations for a period of time
beyond the three years that data in the PI covers.
o Panels suggest that 82% of patients on Copaxone were able to walk
independently, but the open-label study cited for the claim does not
constitute substantial evidence and the claim misleadingly suggests that
Copaxone prevents the progression of disability.
o A statement on the exhibit panel that Copaxone does not include an
indication for slowing progression of disability is not sufficient to mitigate
the misleading representations.
Omission of Risk Information:
o Webpages and patient testimonials include numerous claims regarding the
benefits of Copaxone, but fail to include any risk information associated
with the drug in the body of the webpages and testimonials.
o Links to “Important Safety Information” and the full PI does not mitigate
the omission of risk information from the webpages.
Omission and Minimization of Risk Information/Unsubstantiated
Superiority Presentation:
o Table on panel listing only three risks of Copaxone, numerous risks not
associated with Copaxone, and a claim that Copaxone has no warnings or
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