CBER Sees False, Misleading Info in Carticel Sales Materials
10/19/2009 CBER’s Office of Compliance and Biologics Quality says that a sales aid and patient
biopsy letters for Genzyme’s Carticel (autologous cultured chondrocytes) overstate its efficacy and make unsubstantiated
comparative claims. A 10/8 notice of violation says that Carticel is derived from autologous cultured chrondocytes harvested from the patient’s
normal, femoral cartilage. It is indicated for repairing symptomatic cartilage defects of the femoral condyle (medial, lateral,
or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic
or other surgical repair procedure.
The prescribing information says that Carticel should only be used in conjunction
with debridement, placement of periosteal flap, and rehabilitation. The independent contributions of the autologous cultured
chondrocytes and other therapy components to outcome are not known.
CBER says that the patient biopsy letters contain
terms such as “long-term” and “for years to come” that are misleading because they imply greater or
longer benefit for Carticel-treated patients than is suggested by the prescribing information or by substantial evidence or
clinical experience. And, it says, the letters fail to present important contextual information that not all patients may
benefit from Carticel implantation and that studies supporting Carticel efficacy cover only four years.
The untitled
letter also says that claims that Carticel “allows many patients to return to a full or higher level of activity”
are misleading because they overstate its efficacy without substantial evidence or clinical experience to demonstrate that
a majority of patients will experience complete resumption of a wide range of physical activities.
In addition,
the letter says, the sales aid contains a bar graph that misleadingly suggests that Carticel is more effective than non-autologous
chondrocyte implantation procedures, but that has not been demonstrated by substantial evidence or clinical experience.
Genzyme was told to immediately stop disseminating violative Carticel promotional materials and to respond with a
list of materials to be discontinued.
This report provided by FDA Webview (www.fdaweb.com) -- the Internet's leading online daily FDA regulatory and compliance news site.
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