Boston Scientific Announces
Two Communications From FDA
NATICK, Mass., Jan. 26-- Boston Scientific
Corporation (NYSE: BSX) today announced it had received two communications
from the U.S. Food and Drug Administration (FDA). The first communication was
a corporate warning letter related to procedures, processes and timeliness of
the Company's corporate quality management system. The second communication
advised the Company that an FDA inspection reviewing the manufacture of the
Company's TAXUS® paclitaxel-eluting coronary stent system, Liberte™ coronary
stent system and Carotid Wallstent® system at the Company's
Galway,
Ireland manufacturing facility concluded with no observations reported.
In general, the corporate warning letter notifies the Company that recent
inspections revealed serious regulatory problems at three facilities and
advises top management that its corporate-wide corrective action plan relating
to three prior warning letters issued to the Company in May and August of 2005
was inadequate. The letter expresses concerns about the Company's quality
systems at six facilities as well as recent recalls, rather than any specific
product performance issues. The FDA corporate warning letter does not prevent
the continued distribution of products referenced in the letter, including the
TAXUS system. It focuses on issues related to the review, analysis and
reporting of product complaints. The FDA does not plan to advise hospitals to
discontinue using the products referenced in the letter, including the TAXUS
system.
The Company recently established a new global complaint information system
designed to help address the types of issues raised in the warning letter. It
has also launched a global, cross-functional initiative to further improve and
harmonize its overall quality systems.
The Company and the FDA plan to meet next week to discuss the issues
raised in the letter.
"Although we are pleased with the result of the inspection of our largest
plant, we have clearly not done enough to resolve the issues raised by the FDA
last year," said Jim Tobin, President and Chief Executive Officer of Boston
Scientific. "We are confident we have addressed many of these issues, but
others have not yet been fully resolved. We will work closely with the FDA to
resolve these outstanding issues, and we believe we are on track to do so
promptly."
"Product quality and performance have always been a top priority at Boston
Scientific," added Tobin. "We are bringing the same urgency to our overall
quality and reporting management. We believe we have made a lot of progress,
but we still have a ways to go. We are looking forward to our meeting with
the FDA and to resolving these issues."
A copy of the warning letter will be available on the FDA's web site at:
http://www.fda.gov.
Boston Scientific is a worldwide developer, manufacturer and marketer of
medical devices whose products are used in a broad range of interventional
medical specialties. For more information, please visit:
http://www.bostonscientific.com.
This press release contains forward-looking statements. The Company
wishes to caution the reader that actual results may differ from those
discussed in the forward-looking statements and may be adversely affected by,
among other things, risks associated with the regulatory process, competitive
product offerings and other factors described in the Company's filings with
the Securities and Exchange Commission.
Source: Boston Scientific Corporation |
