We know that much
of the Synvisc being sourced for this purpose is coming from the
Middle East and Europe. We have become aware of several instances
where this product has been tampered with and re-packaged with
photocopied US product information. We have always been concerned
about the quality of product that is purchased outside of our
established distribution channels, since we cannot ensure that
proper storage and shipping conditions have been maintained. These
concerns are substantially magnified in cases where the product has
been opened or otherwise tampered with.
We appreciate your
use of Synvisc and the confidence in our product that this use
demonstrates. There are established direct and wholesale channels for
the purchase of FDA approved Synvisc that provide a safe and effective
product. We encourage you to use these established channels to ensure
the safety and integrity of the product you are using.
Should you have any
questions as follow-up to this communication, please don’t hesitate to
contact your local Synvisc sales representative or call Synvisc customer
service at 1-888-3-SYNVISC.
Sincerely,
C. Ann Merrifield
President,
Genzyme Biosurgery
www.genzyme.com
Tel 617-494-8484
Is the product being
sold by the cross-border distributors U.S. labeled Synvisc?
No.
Genzyme only distributes Synvisc in the U.S. direct to physicians or
medical practice customers or through our established wholesale
vendors. If Synvisc is being sold via the internet or by distributors
that are not approved Genzyme wholesale partners it is not Synvisc that
complies with U.S. labeling requirements. To the extent that the
product being sold by these cross-border distributors contains FDA
approved product and patient labeling; it has been purchased outside of
the U.S. tampered with and illegally repackaged.
Where is the product
coming from?
Our
evidence indicates that much of the product that has most recently been
sold by these cross-border distributors has been sourced from the Middle
East, Turkey, and Germany.
If the product is not
U.S. labeled Synvisc how can it contain the FDA approved product and
patient labeling?
We believe
that many of the cross-border distributors are purchasing Synvisc in
other parts of the world, re-packaging it and replacing the non-U.S.
labeling with a photocopy of the FDA approved package insert. This
practice causes us (Genzyme) great concern because to ensure a safe and
effective product, the product must not be tampered with. This also
poses a potential safety hazard to the patient, as there is no way for
us to ensure that this product was handled appropriately.
Why does Genzyme care
if I buy Synvisc labeled for non-U.S. use?
Once our
product has been sold to our approved vendors outside of the U.S. we
lose control of our ability to track the product and assure that it has
been handled properly to ensure safety. We have no way of ensuring that
any of the product that is being provided by these cross-border
distributors has been handled using Genzyme’s approved distribution
methods. Therefore the product being offered by these cross-border
distributors may be unsafe or ineffective. These concerns are magnified
due to recent situation were the packaging has been opened and tampered
with.
What is Genzyme doing
to stop this dangerous activity?
Genzyme is
currently working with its global distributors to stop this activity and
ensure that Synvisc is only being distributed through approved
distributors.
