House panel requests marketing documents from pharmaceutical companies regarding off-label drug promotion

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Mar 8 2007

The House Committee on Oversight and Government Reform has asked two stent manufacturers and three drug manufacturers to provide documents regarding the marketing of their products as part of the committee's investigation into the off-label use of drug-coated stents and prescription drugs, the Wall Street Journal reports.

Boston Scientific and Johnson & Johnson's Cordis unit are the only makers of drug-coated stents approved in the U.S., 60% of which are prescribed for off-label uses (Winstein, Wall Street Journal, 3/6).

In a letter to Boston Scientific CEO Jim Tobin, committee Chair Henry Waxman (D-Calif.) requested information about whether the company's marketing department funded any clinical studies on its Taxus stents, whether it withheld the results of any studies and whether it paid any of the studies' authors or doctors.

Waxman sent a similar letter to Cordis to inquire about marketing practices related to its products.

The letters asked for records of sales training presentations and "all internal or external presentations or reports relating to off-label use."

Records of any contributions the companies made to cardiology societies and events also were requested.

The letters cited the findings of a two-day FDA hearing in December 2006 at which a panel of experts cautioned about safety risks associated with off-label use of drug-coated stents (Heuser, Boston Globe, 3/6).

In a letter to Eli Lilly, Waxman requested information regarding its schizophrenia drug Zyprexa and cited allegations that the company "misled physicians and inappropriately promoted off-label uses" of the drug.

A letter to AstraZeneca requested information related to its schizophrenia drug Seroquel, and a letter to Cephalon asked for information about its narcotic painkillers Actiq and Fentora (Reuters/New York Times, 3/6).

A spokesperson for Waxman said the letters marked a preliminary examination of off-label use "given the allegations that have been out there" (Winstein, Wall Street Journal, 3/6).

This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.