Lawmakers Investigate FDA's Handling of Cordis Warning Letter

Two high-ranking members of Congress have sent letters 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 announced 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 cGMPs 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. The malfunction was discovered in late August 2003, but the FDA cited the company for failing to fully investigate the events.

Cordis recently announced it received FDA notification that the issues in the 2004 warning letter were resolved and the letter was lifted.

Dingell and Stupak’s letters expressed concern that, despite these “numerous violations,” Cordis was allowed to continue marketing Cypher stents.

J&J said that the company will cooperate with the committee’s request for information. “Consistent with typical FDA practice for warning letters related to quality issues, Cordis continued to manufacture the Cypher stent while it addressed the good manufacturing practice deficiencies raised in the warning letter,” the company said.

The 2004 warning letter can be viewed at www.fda.gov/foi/warning_letters/archive/g4601d.pdf.