FDA Should Review Potentially Deceiving Television Advertisements For Johnson & Johnson Stent, NEJM Opinion Piece Says

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology;  Regulatory Affairs / Drug Approvals
Article Date: 16 May 2008 - 10:00 PDT

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Television advertisements for Johnson & Johnson's drug-coated Cypher stent might deceive consumers and should be reviewed by FDA, according to an opinion piece published Wednesday in the New England Journal of Medicine, the New York Times reports. According to the opinion piece -- written by William Boden, a cardiologist at State University of New York at Buffalo's medical center, and George Diamond of Cedars-Sinai Medical Center -- the 60-second ad, the first DTC ad for a stent, does not completely warn consumers about potential adverse events that can occur as a result of receiving a stent. The ad, which has been airing since Thanksgiving Day in 2007, mentions heart attack and stroke but does not warn of other serious complications that can occur, such as a ruptured coronary artery.

Boden and Diamond write that FDA should "perform a critical post-release review" of the ad campaign "to assess whether it meets the basic regulatory requirements for non-deceptive advertising." Boden and Diamond also question the benefit of DTC advertising for complicated medical devices.

The authors write, "The notion that television viewers inspired by such an ad would go to their physician and request not only a stent but a specific brand and model of stent is frightening, if not utterly absurd." Boden on Wednesday said, "This involves very sophisticated technology, totally in my view beyond what any sophisticated lay consumer could possibly learn from a 30- to 60-second television ad."

FDA spokesperson Karen Riley said the agency would not comment on Boden and Diamond's request for review of the ad.

Officials from Cordis, the J&J subsidiary that manufactures the stent, said in a statement that FDA had reviewed the ad before it aired. Christopher Allman, a J&J spokesperson, said the ad was no longer running nationally but was still being broadcast in Baltimore.

According to the Times, the opinion piece "comes as pressure mounts on the FDA to limit consumer medical advertising or at least to increase oversight of it." Medical device ads are "not as closely monitored as drug ads," but FDA "does regulate ads for so-called high-risk medical devices, including stents," according to the Times. FDA has been reviewing a set of guidelines proposed in 2004 for advertising medical devices, the Times reports. An FDA advisory panel on Friday is scheduled to discuss DTC advertising for drugs and whether television ads should encourage consumers to report adverse events to the agency, similar to a requirement for print ads (Saul, New York Times, 5/15).

The NEJM opinion piece is available online.

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