The U.S. House Committee on Energy and Commerce is looking into whether the Food and Drug Administration may have been too lenient in its treatment of Cordis Corp. after the agency warned the company in 2004 about manufacturing violations relating to its Cypher sirolimus-eluting coronary stent.
In letters sent to FDA Commissioner Dr. Andrew von Eschenbach and to Johnson & Johnson CEO William Weldon in August, the congressional committee said it was seeking all documentation relating to FDA inspections of six Cordis facilities in 2003.
Following those inspections, the agency sent a warning letter to Cordis, a Johnson & Johnson subsidiary, in April 2004 citing violations in good manufacturing practice regulations. The FDA found “systemic violations in the quality management system employed to ensure the safety and effectiveness of your drug-eluting stents that recurred at several of your facilities,” wrote the agency in its warning letter.
“Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents,” wrote Committee Chairman Rep. John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Rep. Bart Stupak (D-Mich.).
Companies are legally entitled to continue manufacturing a drug or device after a issuance of warning letter. If there is a public health threat, the agency will seek a voluntary recall. Otherwise, until the violations cited in a warning letter are resolved, a manufacturer can't receive approval of other new or pending applications for drugs or devices. For Cordis, that hold lasted from April 2004 until June 2007.
In an interview, Ira Loss, an analyst who follows the medical device and pharmaceutical sectors for Washington Analysis Corp., noted that Cordis lost ground to competitors that had carotid stents approved while its carotid device was on hold. He said it was not clear why the Energy and Commerce panel would be pursuing an action against Cordis now.
The first half of 2007 has been a dismal one for drug-eluting stents. When compared with the second quarter of 2006, U.S. sales of Cypher dropped 41% in the second quarter of 2007, to $210 million, reported Johnson & Johnson. Sales outside the United States dropped 30%, to $240 million.