Comments on: New Law Gives FDA More Control http://beautyandthebreast.org/2007/11/20/new-law-gives-fda-more-control/141 Tue, 06 Jan 2009 08:23:58 +0000 http://wordpress.org/?v=2.3.3 By: Amy http://beautyandthebreast.org/2007/11/20/new-law-gives-fda-more-control/141#comment-424 Amy Wed, 21 Nov 2007 19:23:35 +0000 http://beautyandthebreast.org/2007/11/20/new-law-gives-fda-more-control/141#comment-424 This is great news on the drug front, but it is unfortunate that they did not make the same regulations for devices. Currently, the FDA does not have the authority to regulate the post approval studies that they required of the breast implant manufacturers. Congress did a great job with drug safety and enforcement, but now it is time for them to do something about the device division! This is great news on the drug front, but it is unfortunate that they did not make the same regulations for devices. Currently, the FDA does not have the authority to regulate the post approval studies that they required of the breast implant manufacturers. Congress did a great job with drug safety and enforcement, but now it is time for them to do something about the device division!

]]> By: Gloria http://beautyandthebreast.org/2007/11/20/new-law-gives-fda-more-control/141#comment-418 Gloria Wed, 21 Nov 2007 00:37:19 +0000 http://beautyandthebreast.org/2007/11/20/new-law-gives-fda-more-control/141#comment-418 Pam, this is very interesting news. Does this mean that the FDA now has the power to enforce the clinical-trial requirement that was a condition for allowing silicone breast implants back on the market? The manufacturers have always dragged their feet about doing the research to demonstrate once and for all the risks of implants over the long-term. They've either done a shoddy job or just not bothered to collect the information because they knew no one would or could do anything about it. As for the database, I think it’s definitely a good thing. Making such information public means that there are more eyes to scrutinize, and more cues as to what people should be keeping an eye out for. I bet that over time, there will be people (ex-FDA staffers, scientists) and organizations (Consumer's Union, the National Research Center for Women and Families) that will begin to routinely explain and interpret the latest info for the public and the mainstream media. Pam, this is very interesting news. Does this mean that the FDA now has the power to enforce the clinical-trial requirement that was a condition for allowing silicone breast implants back on the market? The manufacturers have always dragged their feet about doing the research to demonstrate once and for all the risks of implants over the long-term. They’ve either done a shoddy job or just not bothered to collect the information because they knew no one would or could do anything about it.

As for the database, I think it’s definitely a good thing. Making such information public means that there are more eyes to scrutinize, and more cues as to what people should be keeping an eye out for. I bet that over time, there will be people (ex-FDA staffers, scientists) and organizations (Consumer’s Union, the National Research Center for Women and Families) that will begin to routinely explain and interpret the latest info for the public and the mainstream media.

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