Lawmakers Investigate FDA’s Handling of Cordis Warning Letter
Two high-ranking members of Congress sent letters last week to Cordis, a Johnson & Johnson (J&J) subsidiary, as well as the FDA, investigating the agency’s handling of a warning letter related to the company’s Cypher stents.
The letters, sent by Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.), request documents and communication relating to the 2004 warning letter. They also announce upcoming interviews of J&J and FDA employees involved with the letter, which cited Cordis for failing to investigate hundreds of adverse event reports concerning the Cypher drug-eluting stent. At the time, inspectors also cited violations of current good manufacturing practices at several facilities.
Dingell is the chair of the House Energy and Commerce Committee, whose staff will conduct the interviews, while Stupak is the chair of its Oversight and Investigations Subcommittee.
The FDA alleged Cordis failed to report several hundred complaints received in 2002 and 2003 through an internet-based tracking system. The system apparently malfunctioned and failed to email event reports to a facility for processing, which significantly lengthened the time frame in which complaints were received and investigated, the warning letter said.