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FDA Warns Boston Scientific of Problems

Posted on: Thursday, 26 January 2006, 21:00 CST

By MARK JEWELL

BOSTON - Federal regulators said Thursday that inspections at Boston Scientific Corp. plants found companywide problems in the medical device maker's quality control, a finding that could block new product approvals as the company tries to conclude its biggest acquisition ever.

"We are directing them to resolve these serious violations promptly, and to do it not as it relates to specific products ... but rather to do it on a corporate-wide basis," said Daniel G. Schultz, director of the Food and Drug Administration office that regulates medical devices.

FDA officials said it was only the third time in the agency's history it has issued such a broad companywide warning involving a medical device company's systems to identify potentially defective and unsafe products.

Natick-based Boston Scientific said it was cooperating with the FDA and hoped to fix the problems promptly.

The FDA found violations in detecting defects and responding to and reporting quality control complaints at three Boston Scientific plants the agency inspected late last summer. The FDA also said the company's efforts to fix problems at three other sites cited in previous FDA warnings were inadequate.

The problems involve plants that make Boston Scientific's top-selling product, the Taxus drug-coated heart stent, as well as Vaxcel implantable drug infusion ports, Leveen needle electrodes, and Enteryx, a device used in surgery to treat acid reflux.

The FDA said it would hold off on approving any Boston Scientific applications to market potentially high-risk devices if the agency determines those products could be affected by the problems it identified.

Until Boston Scientific can convince the FDA the problems have been fixed, the agency also will in some cases not process foreign countries' requests for the FDA to certify that a Boston Scientific export product meets manufacturing standards.

"We will look at each certification individually in relation to the warning letter," said Murray Lumpkin, deputy commissioner for an FDA office overseeing international matters.

FDA officials declined to say whether they might take other steps such as seizing product inventory if Boston Scientific fails to promptly fix the problems, and they didn't say whether the problems had led to patient injuries or deaths.

FDA officials are scheduled to meet with top Boston Scientific executives Feb. 3.

"For this meeting, you should come prepared to discuss your current corporate strategy to bring all your facilities into compliance," the FDA's letter said.

The FDA said it sent the letter to Boston Scientific on Wednesday, several hours after Guidant Corp. accepted a $27 billion buyout bid from Boston Scientific. Guidant's acceptance ended the Massachusetts company's nearly two-month bidding war for Guidant with Johnson & Johnson.

Boston Scientific and the FDA separately disclosed the warning letter Thursday, after Boston Scientific's shares closed down 39 cents, or 1.7 percent, at $23.15 on the New York Stock Exchange. In after-hours trading, its shares were off 46 cents, or 2 percent.

The problems the FDA identified in the late summer inspections involved the company's headquarters and facilities in Maple Grove, Minn., and Spencer, Ind.

The FDA also cited continuing problems at sites where it had previously found shortcomings. These are in Watertown, Mass.; Glens Falls, N.Y., and Quincy, Mass.

The FDA letter also expressed concern about recent Boston Scientific recalls, including one involving nearly 100,000 stents in the summer of 2004 blamed on a manufacturing defect the company has said is now fixed. In October 2004, the FDA said its review had confirmed the problem had been fixed.

Boston Scientific said it had received both the warning letter and another notification from the FDA that its inspectors had found no problems at a stent manufacturing plant in Galway, Ireland.

"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, Boston Scientific's president and chief executive. "We are confident we have addressed many of the issues, but others have not yet been fully resolved."

Meanwhile, Boston Scientific also is trying to secure shareholder and antitrust approval for its Guidant acquisition by the end of March.

FDA officials said they had no authority to act in a consulting role regarding public health questions to the Federal Trade Commission as it reviews antitrust issue raised by Boston Scientific's Guidant acquisition.

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On the Net:

Boston Scientific: http://www.bostonscientific.com

FDA warning letter to Boston Scientific: http://www.fda.gov/foi/warning-letters/g5691d.pdf

Source: Associated Press/AP Online

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