Rep. Henry Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee, recently sent letters to Boston Scientific and Johnson & Johnson (J&J) asking the firms for information on their drug-eluting stents.

Boston Scientific makes the Taxus paclitaxel-eluting stent and J&J's Cordis unit makes the Cypher sirolimus-eluting stent. Waxman's request is part of his committee's investigation into marketing practices and product safety.

Waxman's request comes after an FDA advisory panel in December 2006 examined the risk of blood clotting from drug-eluting stents.

In the letters, Waxman asked for:All documents relating to the development of the printed labels for the products, including all communications within the firms and between the firms and the FDA;A list of all trials, studies or reports initiated, supported or sponsored by the firms relating to their drug-eluting stents;All documents provided to the FDA panel in December 2006; and Documents relating to the development of the firms' respective stent products (from March 2003 to the present for Boston Scientific and from June 2002 to the present for Cordis). Such documents include training materials, presentations to physicians, sales data and adverse event documentation.

Both firms said they intend to provide Waxman with the requested materials and to cooperate with the committee's investigation.

( http://www.fdanews.com/ddl/34_11/ )