Jerry Avorn ran a statistical analysis in the NEJM showing that there were more black box warnings and discontinuations after PDUFA than before.
If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.
Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.
On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....
The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...
http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1
http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj
If he is trying to show that PDUFA means unsafe drugs he is making a logical leap not supported by his numbers crunching. Increased black box warnings are a result of greater vigilance and post-market review. And lumping discontinuations with black boxes is a slick statistical trick to mask the fact that product removals as a percent of all new molecular entities has remained fairly stable at 2-3 percent for decades and after PDUFA. Ask the FDA.
Meanwhile Janet Woodcock underscores what is really at the heart of the current slowdown in drug approvals and greater scrutiny: we know more and understand more. And often companies dump too much data on the FDA that is not informed by what we know but by what companies thinks the agency wants.
On the other hand, what explains the fact that some important medicines have received European approval even as they languish at the FDA? To be sure, Europe has often approved new drugs first and faster. However it is hard not to believe that having Grassley, Waxman, Stupak looking to turn new drug into a new scandal is slowing things down....
The Critical Path should lead to more science-based and population specific standards. But don't expect Avorn or any FDA commissioner wannabe to be satisfied...
http://www.ft.com/cms/s/0/7ae3646a-fad6-11dc-aa46-000077b07658.html?nclick_check=1
http://online.wsj.com/article/SB120648160360663519.html?mod=googlenews_wsj