Boston Scientific Corporation Warned By FDA On Plants

NATICK, Mass., Jan. 26 /PRNewswire-FirstCall/ -- Boston Scientific Corporation 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(R) paclitaxel-eluting coronary stent system, Liberte(TM) coronary stent system and Carotid Wallstent(R) 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.

CONTACT: Milan Kofol 508-650-8569 (Office) 617-834-8595 (Mobile) Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 (Office) 508-667-5165 (Mobile) Media Relations Boston Scientific Corporation Boston Scientific Corporation

CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569 (Office) or+1-617-834-8595 (Mobile), or Paul Donovan, Media Relations, +1-508-650-8541(Office) or +1-508-667-5165 (Mobile), both of Boston Scientific Corporation

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