inside:
FDA’s External Memory: Committees Push REMS ■ page 16
vol. 5, no. 8 | September 2010 | elsevier business intelligence | www.therpmreport.com
A July to Remember July 2010 featured one hot topic after another—Avandia, Qnexa, opioids, REMS, Avastin, Brilinta, Lovenox. We offer 10 themes to think about heading into the fall. n
page 6
Weighing the Regulatory Climate:
The Qnexa Review
c o l u m n s
Free Speech ...............................2 Common Sense ........................ 32 FDA Beat .................................. 34 CMS Beat ................................. 46 Pointed View ............................ 49
If you want to know how much the regulatory climate has improved at FDA since 2007, the agency’s approach to Vivus’ weight loss drug Qnexa is all you need to know. But if you want to know how fundamentally the regulatory model has changed, listen to what an advisory committee said in rejecting the application. n
page 34
Opioid REMS Takes Shape An FDA advisory committee rejected the agency’s carefully crafted class-wide opioid REMS proposal. But sponsors in the class should embrace it anyway. n
page 18
Brilinta: Imported Efficacy AstraZeneca won two strong votes in favor of approval of its clot busting drug Brilinta from an FDA advisory committee, despite a failure to show efficacy in North America. n
“The road to regulatory hell is paved with surrogate endpoints.”
page 26
–Avandia Advisory Committee member Gerald van Belle, PhD
d a s h board The Cost of Doing Business with FDA Pharma companies can only wish that their revenues were growing as fast as the cost of new drug application fees over the past decade. 1,600,000 1,400,000
Fee
1,200,000 1,000,000 800,000 600,000
Don’t Wait For The Next Issue! Now you can get RPM’s analytical coverage more rapidly on the web – www.TheRPMreport.com
400,000 200,000 0
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
SOURCE: FDA, The RPM Report