Comments on: It Takes The FDA How Long To Approve Generics? http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/ News, Comment and Conversation Fri, 10 Feb 2012 22:41:40 +0000 http://wordpress.org/?v=2.6.2 By: Dan http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/#comment-360117 Dan Sat, 14 Jun 2008 02:24:36 +0000 http://www.pharmalot.com/?p=14115#comment-360117 My opnion, but there seems to be a correlation between the PDUFA and priority reviews doubling in only a period of a few years. Eight years ago, if a pharma company paid the FDA a solid million dollars aside from the PDUFA, they have bought a priority review. A little known fact. My opnion, but there seems to be a correlation between the PDUFA and priority reviews doubling in only a period of a few years. Eight years ago, if a pharma company paid the FDA a solid million dollars aside from the PDUFA, they have bought a priority review. A little known fact.

]]> By: CMC guy http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/#comment-360094 CMC guy Sat, 14 Jun 2008 00:14:04 +0000 http://www.pharmalot.com/?p=14115#comment-360094 While poor performance indeed a limited resources verses burden seems to be largely responsible as "ANDA submissions have increased at more than double the rate of review resources in the last 5 years". There were 989 submissions in 2006 so is a huge amount of information to deal with. I don't know how many Chemistry Reviewers FDA has in total much less ones dedicated to OGD (to those who do not know Chemistry includes Chemistry, Manufacturing and Controls, CMC, and is typically bulk of an ANDA unlike NDAs which are largely Clinical. CMC Sections are highly technical and diverse in content). Looking at time factor alone may be a bad metric as impression is iterative since appears other areas don't really engage until Chemistry passes. The fact that only 4% get approve/approvable (96% reject) is very curious. Although some generics submissions come from inexperienced manufacturers there are many that should know how to it right. While poor performance indeed a limited resources verses burden seems to be largely responsible as “ANDA submissions have increased at more than double the rate of review resources in the last 5 years”. There were 989 submissions in 2006 so is a huge amount of information to deal with. I don’t know how many Chemistry Reviewers FDA has in total much less ones dedicated to OGD (to those who do not know Chemistry includes Chemistry, Manufacturing and Controls, CMC, and is typically bulk of an ANDA unlike NDAs which are largely Clinical. CMC Sections are highly technical and diverse in content). Looking at time factor alone may be a bad metric as impression is iterative since appears other areas don’t really engage until Chemistry passes.

The fact that only 4% get approve/approvable (96% reject) is very curious. Although some generics submissions come from inexperienced manufacturers there are many that should know how to it right.

]]> By: Atlex http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/#comment-360084 Atlex Fri, 13 Jun 2008 23:35:25 +0000 http://www.pharmalot.com/?p=14115#comment-360084 Nathan, I think that the vast majority of these delays apply to generics that are the 5th, 6th, 10th, 12th to market, not the first 2 or 3. Atlex Nathan,

I think that the vast majority of these delays apply to generics that are the 5th, 6th, 10th, 12th to market, not the first 2 or 3.

Atlex

]]> By: Dan http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/#comment-360077 Dan Fri, 13 Jun 2008 22:44:38 +0000 http://www.pharmalot.com/?p=14115#comment-360077 It's somewhat Pavlovian. Let's virtually eliminate the requirements of approval mandated to the branded companies, so we can increase the volume of generics. Then the closure time seems to be longer than the development process. Remember the FDA's mission statement: "To promote and protect public health" Enron had a mission statement, too. It’s somewhat Pavlovian. Let’s virtually eliminate the requirements of approval mandated to the branded companies, so we can increase the volume of generics. Then the closure time seems to be longer than the development process.

Remember the FDA’s mission statement:

“To promote and protect public health”

Enron had a mission statement, too.

]]> By: Nathan http://www.pharmalot.com/2008/06/it-takes-the-fda-how-long-to-approve-generics/#comment-360069 Nathan Fri, 13 Jun 2008 22:00:18 +0000 http://www.pharmalot.com/?p=14115#comment-360069 Big deal -- the FDA is taking forever to review NDA's too. It wouldn't be exactly fair if they were late reviewing NDA's but then were on-time reviewing ANDA's. They need to be consistant with both in order to give a "fair" lifetime for brand-name drugs. Big deal — the FDA is taking forever to review NDA’s too. It wouldn’t be exactly fair if they were late reviewing NDA’s but then were on-time reviewing ANDA’s. They need to be consistant with both in order to give a “fair” lifetime for brand-name drugs.

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