Cancer drug shortages
January 12, 2012
THE decision by Ben Venue
Laboratories to extend the
voluntary suspension of
manufacturing at its Bedford Ohio
facility may create shortage of the
cancer medication Caelyx
(doxorubicin) until as late as the
fourth quarter this year.
Ben Venue Laboratories is the
manufacturing arm of Bedford
Laboratories, a Boehringer
Ingelheim company, is one of the
largest sterile injectable facilities in
the world.
The company is also the solesource
manufacturer of J&J’s
ovarian cancer and multiple
myeloma therapy Caelyx, as well as
several other medically necessary
drugs.
The suspension of operations
occurred on 19 November as a
result of a joint inspection by the
FDA and EMA which found several
contamination and quality
management issues, and that the
facility’s equipment was overdue
for maintenance and requalification.
The extension of the facility’s
shutdown, according to Ben
Venue, is now required to address
the manufacturing problems and
to undertake major reconstruction
works.
“Ben Venue is now in a position
where it can no longer continue to
manufacture and remediate
simultaneously and must direct its
focus on addressing manufacturingrelated
issues,” the company said
in a statement.
The company said that it is in the
process of working to restore some
manufacturing in the first quarter
of 2012, but that reconstruction
work may take up to nine months
to complete.
“As we address the facility and
equipment issues in each factory,
we will resume production, likely
one line at a time,” the company
said.
“We anticipate that no products
manufactured in the North facility
will be available to patients and
healthcare professionals before
the fourth quarter of 2012,” the
company added.
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