tag:blogger.com,1999:blog-36762711.post4469347958933049102..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Caronia Web RoundupRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger1125tag:blogger.com,1999:blog-36762711.post-35493997864142445702012-12-14T20:16:35.416-05:002012-12-14T20:16:35.416-05:00I am still wondering how "truthful" prom...I am still wondering how "truthful" promotion means in practice.<br /><br />1. If there is one published study suggesting good safety/efficacy balance and 4 studies (unpublished) of which company is aware that show the contrary, is promotion of that indication "truthful"? <br /><br />2. Does it matter if FDA has the unpublished data?<br /><br />3. Do all five studies need to be mentioned to be "truthful"?<br /><br />4. Must one prove conscious intent to deceive--as opposed to, well, speculative reflection--in order for promotion to be "truthful"?<br /><br />5. If speculative reflection is presented as something more substantive than speculative reflection--like: "Yeah, we're working on that; very promising possibilities"--is it "truthful"?<br /><br />Anonymousnoreply@blogger.com