The National Research Center for Women & Families released a report that suggests a lot of FDA rubber-stamping of approval of new medical devices and drugs.
A news release on the group's website quotes Center president Dr. Diana Zuckerman:
"From our analyses of the FDA advisory committee voting patterns and committee discussions, our study shows advisory committee members usually recommending approval, even if they have strong concerns about the products' safety and effectiveness. And, on those rare occasions that the advisory committee opposes approval, the FDA frequently approves the product anyway. That is especially likely for medical devices." ... "Our study indicates that even one committee member with a financial conflict of interest could easily influence the votes of the entire committee, and thus the FDA decision to approve the product."
Posted by schwitz at September 5, 2006 10:13 AM | TrackBackThe trend right now is to drop the FDA gold standard for safety.
When senior management at FDA says that they want to promote innovation by putting medicine back into the hands of doctors and take it out of the hands of statistician working for big government authorities, it is naive to think that FDA approval will continue to mean safety.
Posted by: scott at September 8, 2006 08:07 PM