tag:blogger.com,1999:blog-9002218232182793493.post8616996001687703062..comments2024-03-28T01:14:05.420-07:00Comments on PharmaLittle: New Drug Development and AccessUnknownnoreply@blogger.comBlogger4125tag:blogger.com,1999:blog-9002218232182793493.post-25242926689492604542009-07-18T18:02:00.872-07:002009-07-18T18:02:00.872-07:00Hi Again Justice,
Two separate reviews that are s...Hi Again Justice,<br /><br />Two separate reviews that are selected on an ad hoc basis - and, I might add, are blinded to one another, should help to instill some integrity back in the process...The reviewers are less likely to be coereced by management or industry. The anonymitity should help the reviewers do their job with out fear of prejudices.<br /><br />I was at a recent "scientific" meeting where clinicians and scientist were intimidated if they asked questions that were not "in line" with the "marketing" message of the product under discussion. This is unacceptable.<br /><br />Science first, patients second and money Third....Former Marketinghttps://www.blogger.com/profile/00141174600868695378noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-35723093877342868132009-07-18T08:39:31.089-07:002009-07-18T08:39:31.089-07:00Re: "another NDA reviewing layer," is th...Re: "another NDA reviewing layer," is that because you feel the FDA in inherently "unfixable" to a reasonable degree or because two separate reviews is inherently better?<br /><br />(Or is the idea to bypass FDA altogether?)Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-42480219765973223822009-07-18T05:25:46.902-07:002009-07-18T05:25:46.902-07:00Hi Justice,
It is not so much what goes to Pharma...Hi Justice,<br /><br />It is not so much what goes to Pharma, it is the overall cost of health care that is important to consider. I think 18% is the more likely figure that goes to Pharma....<br /><br /><br />I am suggesting the creation of another NDA reviewing layer....Former Marketinghttps://www.blogger.com/profile/00141174600868695378noreply@blogger.comtag:blogger.com,1999:blog-9002218232182793493.post-19552779084049449672009-07-17T11:43:02.757-07:002009-07-17T11:43:02.757-07:00Hi Former,
I suspect you have provided so much to...Hi Former,<br /><br />I suspect you have provided so much to chew on that it is hard to begin the meal!<br /><br />So just a couple of notes.<br /><br />Re: healtcare spending, of course, just a fraction of it goes to drugs. PhRMA usually says 9%. Experts who have reviewed the figure to include Medicare spending and related bring it up to about 18%.<br /><br />In your second proposal, and part of the first, it sounds like you want to create a "back-up FDA," but perhaps I'm missing the point. If not, my own inclination would be more targeted and, in some arenas, radical reform of the FDA we have than to create another NDA reviewing layer.Henry (Hank) Greenspanhttps://www.blogger.com/profile/11367665602949729228noreply@blogger.com