GDUFA II Negotiations and FDA Trends

We all know that the GDUFA II negotiations are in full swing.  Among topics being discussed are fee issues associated with small businesses and especially the subject of establishment fees and whether they should be collected only after ANDA approval.  This is also on the radar of Congress and will likely get some significant attention in the negotiation discussions.

Publically, the minutes of meetings also address areas like negotiations of GDUFA goal dates for application review, supplement review times, and amendment review times for responses from firms.  There are a lot of moving parts, and we will need to see where both parties (FDA and industry) ultimately rest.

Some interesting trends that we have seen during the negotiations relative to FDA review and approval activities are as follows:

Approvals on the rise – or are they?

We saw a few good months with approval up sharply after the beginning of the start of year four of GDUFA I.  However, January and February (so far this month up to the 18th only 24 ANDAs are listed as approved on the FDA monthly approvals list) have been somewhat a step back from the numbers we have seen in the first few months of this FY.  With Dr. Uhl’s presence at the GPhA annual meeting on Wednesday, we will have to see if some ANDAs get pushed through.  FDA has noted that approvals should be up this year, a fact that I don’t believe will be disputed, but how much.

IRs and ECDs Rise dramatically

The communication of information requests (IRs) and easily correctible deficiencies (ECDs) are clearly testing industry’s ability to respond.  With numbers of letters in the 700s flying out to industry, FDA is clearly approaching its goal of getting the ball rolling throughout the GDUFA review clock, so that firms and the Agency can improve their firstcycle approvals.  With one (I believe) first cycle approval under GDUFA year three on the books, it will be interesting to see how these IR and ECDs impact on first cycle approvals over the next year or two.

ANDA receipts popped up in December

With the number of original ANDA receipts hitting 180 in December 2015, I am certain that OGD was getting nervous.  Could this be another 1000 ANDA receipt year? Maybe not, but it will likely beat last FY’s total of 539.  The impact of receipts are a driving factor in regard to how much review time FDA can spend on the “old backlog” applications and years 1 and 2 GDUFA submissions that don’t have GDUFA goal dates, but instead, have Tentative Action Dates (TADS).

Supplements – what’s up with them?

We don’t see much change in PAS or CBE supplements over the first few months of FY 2016.  There are still about 40 PAS supplements a month and about 450 CBE-30 submissions a month (albeit October 2015 saw well over 600 CBE-30s and the following two months saw in about 370 per month).  We will need to watch the supplemental trends.  Didn’t FDA talk about reducing the requirements for reporting some changes via supplements?  Well, we have not seen much relief there, to date.

GDUFA post CR meeting requests

There have been, surprisingly, few post-completed response meeting requests, at least during the first three months of GDUFA year four with only 6 requests.  I guess firms are better understanding the questions they are getting in the CRs – maybe that is because they need to raise the issues during the IR and ECD phases of the ANDA review.


Much discussion is revolving around inspectional activity and ANDA approval.  The issue of risk-based inspection continues to be discussed (we were discussing this in 1984), but now it sits center stage.  With top FDA officials saying ANDA approval will not be held up because of inspections, the industry would like to see how that is going to play out in real life.

So, that is how I am seeing things so far this year.  If you have any other observations, please write me at  I look forward to hearing from you.