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CIAO DATE: 6/5/2006
Striking a Balance: Drug Labeling and the FDA
John E. Calfee
February 2006
Abstract
Today's pharmaceutical warning labels contain little useful information for consumers; rather, they attempt to over-warn of every potential side effect so as to protect manufacturers from getting sued. A new Food and Drug Administration labeling rule could provide better information to consumers and prevent hyperactive litigation.
With the fourth Vioxx lawsuit currently under way, a fourth jury is in the thick of trying to determine whether Merck is indeed liable for any injuries that may or may not have arisen from the use of its blockbuster arthritis drug. The trials have highlighted bad tort bar science in all its dubious glory--from questionable pathology reports to seriously exaggerated claims about the dangers of Vioxx--but they also raise a deeper issue. Every drug presents patients and doctors with a trade-off between benefits and risks. But how can physicians and drug companies strike a balance in the age of a hyperactive litigation?