Originally published February 15 2006
FDA imposes further restrictions on Guidant
by Mike Adams, the Health Ranger, NaturalNews Editor
New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures.
WEDNESDAY, DECEMBER 28, 2005 NEW YORK The Food and Drug Administration has released a warning letter it sent to Guidant restricting the ability of the troubled heart device maker to win approval for some new products.
In the letter, sent a week ago, the agency said Guidant had not fully responded to its concerns about manufacturing procedures at the company's biggest plant.
Along with suspending some new product approvals, the agency said it would no longer issue new export permits for devices made at the company's plant in St. Paul, Minnesota.
After striking a deal late last year to be sold for $76 a share to Johnson & Johnson, the big health care products company based in New Brunswick, New Jersey, Guidant's stock has risen and fallen in rapid succession on optimism about its acquisition on the one hand, and mounting worries about recalls and investigations on the other.
Cordis, a Johnson & Johnson subsidiary, received a warning letter in April 2004, concerning its record-keeping, processing of complaints and production of its Cypher stents, which are drug-coated metal sleeves that prop open coronary arteries after blockages have been cleared.
On Friday, the company lowered its sales and profit forecast, saying that demand for its devices had declined after product recalls.
Also last week, documents filed in a Texas lawsuit showed that Guidant officials had projected that some patients might die because of short circuits in one of the company's implantable defibrillators.
After striking a deal late last year to be sold for $76 a share to Johnson & Johnson, the big health care products company based in New Brunswick, New Jersey, Guidant's stock has risen and fallen in rapid succession on optimism about its acquisition on the one hand, and mounting worries about recalls and investigations on the other.
A spokesman for Johnson & Johnson, Jeffrey Leebaw, declined to comment on the letter Tuesday.
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