Tuesday, December 05, 2006

FDA waives rules for expert panel on stents

Back story here.

Six physicians with financial ties to Johnson & Johnson and other heart-device makers will be advising U.S. regulators whether to restrict the use of some products because of potentially lethal side effects.

The doctors will serve this week on a FDA panel of experts in Washington reviewing blood clots linked to stents. The panel members, listed on an FDA Web site Nov. 22, will include Robert Harrington, who runs a Duke University research institute funded by stent makers J&J and Boston Scientific Corp.

To allow the doctors to participate in the review, the FDA is waiving rules that bar panelists from serving in matters affecting companies in which the experts have stock ownership or consulting contracts.

Regulators say expert researchers often consult for makers of products under review. Agency critics, including Republican Sen. Charles Grassley of Iowa, say only advisers without financial conflicts should be chosen.

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