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May 10, 2007

Senate Bill Intended to Increase FDA Drug Regulation Power

The Senate approved a bill Wednesday that would give the FDA new power to monitor drug safety, order drug label changes, regulate advertising, and restrict the use and distribution of drugs that pose serious risks to consumers.  The bill, which passed the Senate by a 93-1 vote, was sponsored by Sen. Edward Kennedy (D., Mass) and Sen. Michael Enzi (R., Wyo.).  It calls for a fundamental change in the philosophy and operations of the FDA.  The bill requires the agency to focus on the entire life cycle of a drug and on the experience of persons using the drug, rather than focusing just on the years before approval.  The Senate made it clear that it wanted stronger agency action to protect public health.  The bill was in response to a widespread loss of confidence in the FDA's ability to protect consumers from dangers from drugs such as Vioxx.  By Robert Pear, New York Times

May 10, 2007 | Permalink | Comments (0) | TrackBack

May 7, 2007

California Smoker Gets Higher Damages on Re-trial

A California smoker whose $1.7 million compensatory damages verdict was overturned on appeal in 2004, won $2.5 million in compensatory damages in a second trial of the case.  At the conclusion of the first trial in 2000, the plaintiff also won $20 million in punitive damages against the two defendants, Philip Morris and R. J. Reynolds.  The entire first verdict was overturned when the California appellate court concluded that the defendants could not be held liable for certain conduct during a 10-year period closed by the California legislature beginning in 1988.  In the retrial, only R. J. Reynolds will face the prospect of punitive damages.  See Matthew Hirsch's story for The Recorder.


May 7, 2007 | Permalink | Comments (0) | TrackBack