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When Kim Witczak of Minneapolis talks about a new federal law that aims to make prescription drugs safer, you realize the issue is personal. "If only some of these changes were in place four years ago, I truly believe my husband would still be alive today," says Witczak, who joined Consumers Union's campaign for drugsafety reform. She believes antidepressants led to her husband's suicide.
In September, Congress passed and President Bush signed into law what is considered to be the most sweeping drugsafety legislation in nearly 45 years. The law, prompted in part by problems with the pain medication Vioxx and the antidepressant Paxil, will require results from clinical drug studies to be made public so that consumers and doctors will know the good and bad news about medications.
Within 18 months, drugmakers will have to post comprehensive summaries of the results of their drug trials on the Internet. The data will be vital to researchers and doctors. It will include information about how a drug performed when tested on humans, and later, information on the drug's side effects.
The Food and Drug Administration will have the power to require a drug company to change its warning labels if safety problems emerge, and to make the company run additional safety studies. Until now, the FDA could ask drugmakers to do follow-up studies but usually couldn't require them. As of last year, some 899 studies had yet to be ...