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
o
o
o
o
o
Summary of Alleged Violations
nonrandomized, uncontrolled clinical trial performed in hemodialysis
patients, and it is unclear how the study defined endpoints or assessed
efficacy parameters.
Claims suggest the addition of sodium ferric gluconate to ESA therapy will
result in a significant cost savings compared to ESA therapy alone due to
the ability of sodium ferric gluconate to improve patients’ response to ESA
therapy over 12 weeks compared to ESA therapy alone, but the claims are
not supported by substantial evidence. One cited study was an open-label,
randomized, controlled trial that primarily assessed the change in Hb level
from baseline and cannot support the 12 week endpoint, and the other
study was a 6-week observational extension of the first study designed to
investigate the extended effects of intravenous ferric gluconate on ESA
dosage under usual clinical management, so adjustments to ESA and
intravenous iron therapy were unrestricted and left to the discretion of the
individual clinicians or study sites.
Statements imply that treatment plus ESAs will have a positive impact on
all aspects of treatment costs compared to treatment with ESAs alone, but
the cited reference does not support these global conclusions because the
studies were not designed to demonstrate the underlying clinical efficacy
premise necessary to support the claim, and the study describes an
economic model that only evaluated drug acquisition costs and costs
associated with hospitalizations.
Disclaimer that the economic model only included drugs and
hospitalizations due to serious adverse events does not correct the overall
misleading impression.
Ad suggests that cost savings is applicable to the general patient population
for which sodium ferric gluconate is indicated when the referenced
economic model was based on a specific subgroup of hemodialysis patients
with iron deficiency anemia undergoing chronic hemodialysis who receive
supplemental ESA therapy.
Footnote describing patients in the model is not adequate to mitigate the
overall misleading impression.
06-07-2012 Kepivance®
To decrease the incidence and
duration of severe oral mucositis in
patients with hematologic
malignancies receiving myelotoxic
therapy requiring hematopoietic
No Webpage Omission of Risk Information:
o Webpage contains claims regarding reduction in the direction of severe
oral mucositis, reduction in the incidence of severe grades of oral
mucositis, and positive impact on patient reported outcomes and associated
measures, but omits important risk information about the drug regarding
the potential for stimulation of tumor growth and drug interactions.
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