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
patients with treatment-resistant schizophrenia, but the clinical trial used to
demonstrate efficacy of the drug does not support these claims and did not
evaluate the long-term effect of clozapine in patients with treatmentresistant
schizophrenia to determine if patients experienced improvement
with no relapses or tolerability issues that would cause discontinuation of
the drug, or that treatment had a sustained effect or response.
09-25-2012 Vantas®
For the palliative treatment of
advanced prostate cancer.
No
Caregiver
Brochure
Omission of Risk Information:
o Brochure fails to state that paralysis may result from the risk of spinal cord
compression and that patients are at an increased risk of developing
hyperglycemia, diabetes mellitus, myocardial infarction, sudden cardiac
death, and stroke.
10-03-2012 Tarceva®
For the maintenance treatment of
patients with locally advanced or
metastatic non-small cell lung
cancer whose disease has not
progressed after four cycles of
platinum-based first-line
chemotherapy; for the treatment of
patients with locally advanced or
metastatic non-small cell lung
cancer after failure of at least one
prior chemotherapy regimen.
No Visual Aids Misleading Efficacy Claims/Minimization of Risk:
o Presentation drastically overstates efficacy by suggesting that in patients
who develop grade 2+ rash, the addition of Tarceva to gemcitabine
provides an additional 3.7 month overall survival (OS) benefit and that
these patients may have a median OS of 10.7 months when the PI states
that the addition of Tarceva increased survival by approximately 12 days.
o The development of rash and its correlation with OS were not pre-specified
endpoints in the pivotal study and were derived from a retrospective,
exploratory subgroup analysis.
o Presentation portrays the adverse reaction of “rash” as an efficacy predictor
and therefore, a potential benefit to patients, when the PI states that grade
3/4 rash was reported in 5% of patients and resulted in dose reductions and
study discontinuation for some patients.
o Statement that data do not support increasing dosage to cause rash does not
mitigate the misleading impression.
o Claims based on retrospective exploratory analyses of a subgroup of
patients with adenocarcinoma and squamous cell carcinoma do not support
claims about reduction in risk of death because although tumor histology
was collected along with other demographic characteristics during
enrollment, there was a lack of adequate prospective statistical design.
Overstatement of Efficacy:
o Presentation strongly suggests that time is standing still for the cancer
patient because of Tarceva therapy, which drastically overstates the OS
benefit for patients because studies do not support the implication that
Tarceva can slow disease progression and greatly improve survival.
o Claim about extending survival “for moments that matter” suggests a
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