Play. I want to thank allen and pew for hosting this meeting, for organizing the publishing of the special supplement and of course to mr. Gottlieb for his remarks at the beginning of the day. So the focus of this final panel today is the fact that in certain high profile cases manufacturers have released incorrect or incomplete information into the market that was directly counter to the information, the contemporaneous information the fda had. They noted that selective publication of Clinical Trial results has in the past created a misleading picture of the safety and efficacy of a product with negative implications for Public Health. And as a the practice now still stands, manufactures have wide latitude to publicly characterize data that were submitted to the fda without much risk that the fda will correct the record. I think were going to try to talk a little bit about in the next hour is, you know, in these cases does the fda have a Public Health or an ethical responsibility to c
[ is distinct conversations ]. And live here this morning on c spann span 3, a discussion about transparency and oversight at the food and Drug Administration. Well be hearing from dr. Scott gottlieb starting off the conference. Introductions under way. Efforts to pass and implement the food safety modernization act, focus on medical devices, especially the potential of using the unique device identifier to improve monitoring devices throughout the product lifecycle. We have successfully worked on products 10 to courage innovation particularly around antibiotics and 10 to sure appropriate use of them. We focused on drug safety and transparency in the supply chain and especially on the safety of compounded drugs. Among other things, pew submitted transparency to the task force back in 2010 if the. They touch on some of the topics well be discussing today. Reading the background papers for todays meet regular mind med of a meeting we convened in a room directly above of us here a few yea
Process to approve new drugs. This is 35 minutes. Thanks a lot. Thanks for the opportunity to be here today. We had a dialogue over many years, and i appreciate the relationship we had talking about policy issues. I wrote a subsequent article saying whats taking you so long, josh. So ive been waiting for him to return the favor, and i just got a copy of it. So i appreciate it very much. Thanks for the opportunity to be here today. Thanks john hopkins for hoestin this, and pew for providing space. Transparency can be a powerful tool for innovation. New platforms for visualizing large complex data sets present important new opportunities for the research and Development Community for regulators and for clinicians. It allows people to harness data to advance the safe and effective and Efficient Development for medical needs and to communicate information supporting regulatory Decision Making in ways that engender Greater Public confidence in those decisions. The fdas goal is to advance tr
I wrote a subsequent article saying whats taking you so long, josh. So ive been waiting for him to return the favor, and i just got a copy of it. So i appreciate it very much. Thanks for the opportunity to be here today. Thanks john hopkins for hoestin this, and pew for providing space. Transparency can be a powerful tool for innovation. New platforms for visualizing large complex data sets present important new opportunities for the research and Development Community for regulators and for clinicians. It allows people to harness data to advance the safe and effective and Efficient Development for medical needs and to communicate information supporting regulatory Decision Making in ways that engender Greater Public confidence in those decisions. The fdas goal is to advance transparency without reducing incentives to innovate. This can be accomplished by meeting our statutory responsibility for protecting confidential, commercial information, trade secrets and private data while dissemi
Thank you very much, josh, for that very nice introduction. I am aaron khere to introduce te final panel of the day that relates to another important set of Public Health functions, that Greater Transparency about information and regulatory decisions about the fda can play. I want to thank allen and pew for hosting this meeting, for organizing the publishing of the special supplement and of course to mr. Gottlieb for his remarks at the beginning of the day. So the focus of this final panel today is the fact that in certain high profile cases manufacturers have released incorrect or incomplete information into the market that was directly counter to the information, the contemporaneous information the fda had. They noted that selective publication of Clinical Trial results has in the past created a misleading picture of the safety and efficacy of a product with negative implications for Public Health. And as a the practice now still stands, manufactures have wide latitude to publicly ch