Jane Harman: “as a woman, mother of four, and corporate lawyer, my life experience intersects the issues involved in this amendment in…”

“as a woman, mother of four, and corporate lawyer, my life experience intersects the issues involved in this amendment in many ways. My decision to support it was a close one for me, and I thank my colleagues on both sides for giving me the time to explain my views. On the one hand, all of us are horrified by the stories of individuals, many of them women, injured by drugs and medical devices. However, on the other hand, there is a fundamental fairness argument, and real evidence that our present system chills research and development on new drugs and medical device breakthroughs which could be enormously helpful to various at-risk communities, especially women. This amendment is based on the view that if a drug manufacturer is in full compliance, and I stress, full compliance with Federal regulatory requirements, it should not be liable for damages designed to otherwise punish that behavior. I agree. To be sure, the FDA is not all-knowing when it comes to assuring product safety, but it is the best mechanism we have available in balancing the social values associated with drugs and medical devices and the unfortunate injuries which may result from known or unknown side effects. If there are ways to improve the FDA's performance, let us do it. There are risk living in a modern, technologically advanced society.”