Wednesday, January 25, 2006
FDA and drug labels
Drug labelling has long been a concern beyond the print being so small you can't read it. The FDA tried to clarify labelling problems to prevent lawsuit problems experienced by drug companies. For example, Vioxx is being sued 9,000 times for its troubles with the claim that they failed to warn of heart problems. One of the reasons for this is the FDA has required simpler labelling so only the most important information is put on labels. Then the state courts which entertain these lawsuits fail to acknowledge the federal requirement which prevents the company from listing all the possible side effects and even some which may be more than rare. Here is an example from real life. In Motus vs. Pfizer the wife of a suicide victim alleged that Pfizer had negligently failed to warn that the antidepressant might actually cause suicidal thoughts. The FDA had already considered requests to put this on the label and said no because it feared the risk of depressed patients skipping treatment with Zoloft to be greater than the known risk from the drugs themselves. When the FDA intervened to help Pfizer with what is called a "pre-emption" assertion, this infuriated some folks. Guess who? If you said the liberal democrats like Senator Kennedy who carries water for the trial lawyers you are right.