Lachman CONSULTANTS - Bob Pollock先生 2014-06-25
校译：识林-柯 2014-06-27
Thinking About the Broader Picture - Will GDUFA Have an Impact on PDUFA?
Written by Bob Pollock • June 25, 2014
I was asked by a reporter how the Office of Generic Drugs (OGD) and FDA were going to respond to the overwhelming number of abbreviated new drug applications (ANDAs) that have been submitted not only in June of this year (see previous post here), but to the record numbers of ANDA submissions in since 2012. At first I thought – well, there is no way they can reasonably be expected to meet their goals under the current GDUFA program. Then I though t- well, they really have no choice but to meet those goals once the kick in, or they will certainly face the wrath of Congress.
Then the stark reality of the situation struck me. There are metrics for the backlog applications (those that were pending prior to October 1, 2012) and OGD must review 90% of those applications by end of FY 2017. Then there are Cohort 1 and Cohort 2 year applications (submitted during FY 2013 and 2014) that have no GDUFA metrics associated with them. ANDAs with yearly review metrics under GDUFA start coming into the Agency on October 1, 2014, those are the year 3 Cohort. The only way OGD has a chance to meet the GDUFA metrics is to ignore Cohort Years 1 and 2 submissions or try to sneak some into the review queue if they have time. That would be a solution that would certainly not be popular with industry or for that matter with OGD. So, unless OGD gets more appropriate funds, or unless they have recruited Supermen reviewers who can jump tall mounds of ANDAs in a single bound and can train themselves faster than a speeding bullet, there is no way! Unless, OGD further taps the new drug review resource to help it deal with its workload.
This should be easier to accomplish under the Office of Product Quality (OPQ) structure because all of the chemists from new drugs and generic drugs are now under one Office. The new drug chemists were enlisted to help the OGD climb out of a large backlog that grew out of the generic drug scandal in the late 80’s early 90’s. New drug chemists are currently helping OGD chip away at the 5000 supplement backlog they faced in 2012. The new drug chemists are a ready, trained resource that can be called upon to aid OGD in this new time of need. But then, there is the question of how the use of the new drug chemists will impact PDUFA review times. This is something that CDER will certainly need to keep a close eye on as the NDA applicants pay considerably more money in user fees to assure timely review of their applications.
So perhaps the balancing act will be on as the tightrope of meeting the UFA goals has been something that the Agency really aims hard to hit. We don’t really know if this is a solution that CDER will pursue, but it seems to this ex-OGDer that they really don’t have any better choices at this point in time. The criticality of the situation may be exacerbated if the rate of ANDA submissions does not taper off significantly over the next few years. The negotiations for GDUFA 2 will certainly be lively should the level of submissions remain the same!
