Comments on: PHARMA: PDUFA Reauthorization: Has Success Spoiled User Fees? http://healthaffairs.org/blog/2007/04/18/pharma-pdufa-reauthorization-has-success-spoiled-user-fees/ The Policy Journal of the Health Sphere Fri, 20 Nov 2009 20:04:42 -0500 hourly 1 By: InsureBlog http://healthaffairs.org/blog/2007/04/18/pharma-pdufa-reauthorization-has-success-spoiled-user-fees/comment-page-1/#comment-2438 InsureBlog Thu, 03 May 2007 16:55:00 +0000 http://healthaffairs.org/blog/2007/04/18/pharma-pdufa-reauthorization-has-success-spoiled-user-fees/#comment-2438 <strong>HWR: The Derby Edition</strong> In honor of the 133rd Run for the Roses, we present the Thoroughbreds of Wonk. Thanks to the expert grooming of Joe and Julie, the Health Wonk Review is a blog carnival of a different color. Thanks, too, to all the bloggers who submitted almost 20 po... HWR: The Derby Edition

In honor of the 133rd Run for the Roses, we present the Thoroughbreds of Wonk. Thanks to the expert grooming of Joe and Julie, the Health Wonk Review is a blog carnival of a different color. Thanks, too, to all the bloggers who submitted almost 20 po…

]]> By: Brad Kirkman-Liff http://healthaffairs.org/blog/2007/04/18/pharma-pdufa-reauthorization-has-success-spoiled-user-fees/comment-page-1/#comment-2080 Brad Kirkman-Liff Fri, 20 Apr 2007 17:15:17 +0000 http://healthaffairs.org/blog/2007/04/18/pharma-pdufa-reauthorization-has-success-spoiled-user-fees/#comment-2080 "PDUFA funding for postmarket surveillance appears to be disproportionately small, whether the remedy sought is reallocation or additional support from the public fisc. The FDA’s proposed bill increases funds for postmarket surveillance, but only from 5 percent of user-fee revenues to 6.7 percent, according to Hennessy." That is disturbing news, if correct. My impression based on conversations and visits is that pharmacoviligence activities in the European Union are more structured and organized than they are in the USA. That was an issue raised in the Institute of Medicine report, "The Future of Drug Safety", which encouraged the adoption of methods used in the EU. On a somewhat related issue of pharmaceutical regulation that might be of interest to some on this blog, the UK Department for International Development is supporting the creation of a Medicines Transparency Alliance http://www.dfidhealthrc.org/MeTA/index.html Quoting from the web site, the intent is to "support national efforts to enhance transparency and build capacity in medicines policy, procurement and supply chain management.." The focus is on collecting and sharing data on quality, availability and price. I seem to recall that for economists that kind of information is like baseball, parenthood and apple pie. “PDUFA funding for postmarket surveillance appears to be disproportionately small, whether the remedy sought is reallocation or additional support from the public fisc. The FDA’s proposed bill increases funds for postmarket surveillance, but only from 5 percent of user-fee revenues to 6.7 percent, according to Hennessy.” That is disturbing news, if correct. My impression based on conversations and visits is that pharmacoviligence activities in the European Union are more structured and organized than they are in the USA. That was an issue raised in the Institute of Medicine report, “The Future of Drug Safety”, which encouraged the adoption of methods used in the EU.

On a somewhat related issue of pharmaceutical regulation that might be of interest to some on this blog, the UK Department for International Development is supporting the creation of a Medicines Transparency Alliance http://www.dfidhealthrc.org/MeTA/index.html

Quoting from the web site, the intent is to “support national efforts to enhance transparency and build capacity in medicines policy, procurement and supply chain management..” The focus is on collecting and sharing data on quality, availability and price. I seem to recall that for economists that kind of information is like baseball, parenthood and apple pie.

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