Merck has agreed to a $58 million settlement with 29 states and the District of Columbia to settle allegations that it downplayed heart risks created by Vioxx in direct-to-consumer advertising. Under the terms of yesterday's agreement, Merck will submit all new TV ads for its drugs to the FDA for seven years, and follow all agency-suggested changes before airing the ads. Merck also agreed to end its practice of "medical ghostwriting," in which paid consultants or employees, rather than physicians listed as lead authors, wrote studies on Vioxx.
The agreement follows a $4.85 billion settlement, which is still pending, that ended most lawsuits resulting from findings that the drug doubled risks of heart attack and stroke. Merck withdrew Vioxx from the market in 2004.
To learn more about the new agreement:
- read this Kaiser Daily Health Policy Report item
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