Tuesday, March 06, 2007

Congressional committee to look at off-label use issues

As reported today in the Wall Street Journal, a congressional committee will examine "the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration." Boston Scientific Corp. and Johnson & Johnson's Cordis unit, have been asked to provide clinical data and marketing materials on their drug-coated stent products to the House Committee on Oversight and Government Reform. In addition:

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
Click here to read the article (subscription required).

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