Lawmakers Probe FDA Over Handling Of Cordis Warning Letter

From the August 20, 2007, issue of "The Gray Sheet"

The House Energy and Commerce Committee sent letters to FDA and Johnson & Johnson Aug. 13 requesting documents as part of an inquiry into FDA's Office of Regulatory Affairs.

The letters, sent by committee Chairman John Dingell, D-Mich., and Subcommittee on Oversight and Investigations Chairman Bart Stupak, D-Mich., refer to an April 2004 warning letter citing "numerous" manufacturing quality systems violations at six facilities producing Cordis Cypher drug-eluting stents and other vascular devices. The warning letter resulted from FDA inspections conducted in 2003.

"Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents," the congressmen write.

A committee staffer told "The Gray Sheet" that the information request is not part of a broader investigation of stent makers. Instead the lawmakers are looking at this inspection and the fallout to answer "questions" about the operations of the Office of Regulatory Affairs, which oversees the agency's field activities.

The staffer said House investigators will look at whether ORA appropriately followed up on the inspection and warning letter in this case.

FDA-Cordis Correspondence Requested

In their letter to FDA Commissioner Andrew von Eschenbach, Dingell and Stupak request that FDA submit all FDA Form 483 reports that have been issued to Cypher production sites; all establishment inspection reports corresponding to the Form 483s; all Cordis responses to these reports; and all communications, including e-mails and meeting notes, from FDA staff involved in the inspections and warning letters.

Further, the committee says it will interview staff at CDRH headquarters and FDA staffers in district offices that participated in the 2003 inspections.

In a separate letter addressed to J&J CEO William Weldon, Dingell and Stupak request all internal J&J communications and correspondence with FDA relating to the inspections and the warning letter.

The congressmen give FDA and J&J two weeks to hand over the information. A Cordis spokesperson said the company "will cooperate with the committee in regard to its request for information." FDA did not return a request for comment on the letters.

Cordis Resolved Warning Letter Issues In June

Most of the violations documented in the 2004 warning letter were related to ineffective procedures for handling complaints and out-of-specification quality-control test results. FDA has characterized it as a "corporate" warning letter, a rare label that signifies the agency's interest in getting executives' attention and highlighting company-wide violations.

The warning letter held up the approvals of several J&J products, including the Precise carotid stent; but in June, the company announced that it had finally resolved with FDA all issues cited in the warning letter.

FDA warning letters documenting quality system violations typically do not result in companies having to take their devices off the market unless the agency is not satisfied with the manufacturer's efforts to address the problems.

Although drug-eluting stents are not the primary focus of the Energy and Commerce investigation, this development contributes to the negative publicity surrounding the products over the last year.

Sales of Cypher and Boston Scientific's Taxus have sharply declined in the wake of growing concerns over the risk of late stent thrombosis, particularly for off-label indications, and data questioning the value of adding stenting to drug therapy in certain heart disease populations.

In March, Henry Waxman, D-Calif. chairman of the House Committee on Oversight and Government Reform, initiated an investigation into the stent sector, requesting information from J&J and Boston Scientific relating to the off-label marketing and use of drug-eluting stents.

- David Filmore

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