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Drug-Eluting Stent Makers Continue to be Dogged by Vexing Problems

First came the news that drug-eluting stents (DESs) were no more effective than their plain metal forebears in preventing myocardial infarction and death in patients with coronary artery disease. Further research also has suggested that the devices could raise the risk of blood clots after implantation and pose a higher risk of complications when they are used off-label. Now, a Congressional investigation into the manufacturing process of 1 DES maker is further impacting use of the devices. Congress is looking into how the Food and Drug Administration (FDA) handled issues related to the stent manufacturing practices of Johnson & Johnson (J&J), based in NewBrunswick, New Jersey, more than 4 years ago. The inquiry is driven by John Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of the Subcommittee onOversight and Investigations. They sent separate letters in August 2007 to FDA CommissionerAndrewvonEschenbach and to William Weldon, chief executive officer of J&J. According to the letter to von Eschenbach, agency inspectors found ‘‘numerous systemic violations’’ related to the manufacturing of the Cypher stent during visits to the facilities of Cordis Corp, a J&J company, in 2003. ‘‘Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,’’ wrote Dingell and Stupak. The FDA would not comment on the letters. After postapproval inspections of Cordis Corp’s plants, the FDA sent a warning letter to the company in April 2004. It cited a range of concerns. Among them were not establishing corrective and preventative actions and failure to validate processes adequately. The FDA lifted the warning letter in June 2007, noting that the problems named in the letter had been resolved. Although issues raised in the warning letter seem to be resolved, Dingell and Stupak are asking for all records related to the warning letter and inspection reports. They also want all communication, including e-mail and meeting notes, from FDA staff connected to the Cordis and Cypher inspections that occurred between July 2003 and April 2004. The letter sent to Weldon at J&J requests all internal J&J communication related to Cordis and Cypher inspections between September 2003 and June 2007.