Congress to Investigate Drug-Eluting Stent MarketingCongress to Investigate Drug-Eluting Stent Marketing
The House Committee on Oversight and Government Reform has subpoenaed documents from Boston Scientific and Johnson & Johnson as part of an investigation into the marketing of drug-eluting stents, the Boston Globe reports.
March 6, 2007
The firms are being asked whether their marketing departments funded any clinical studies, whether they withheld any study results, and whether they paid any doctors or study authors. The committee also seeks information on sales training records, presentations to doctors, funding of cardiology societies and events, and any mention of off-label use in a presentation or report.Â The letter, from committee chairman Henry Waxman (D-CA), appears to have been prompted by revelations from December's FDA panel meeting on drug-eluting stent safety. That meeting concluded that the products are safe in the patient populations for which they were approved, but that about 60% of the time they are used off-label, on patients with more complex problems than those in the pivotal studies. Given that breakdown, Congress is concerned about whether J&J and Boston Scientific engaged in off-label promotion,Â certain forms of whichÂ are not legal. Both firms said they will comply with the request.
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