Making Progress Under GDUFA – Well, Not Quite Yet!

We have seen recent articles in which both FDA and Office of Generic Drugs (OGD) are touting their progress made under the Generic Drug User Fee Act of 2012 (GDUFA).  But we are almost 10 months into year one of the program and hiring is just really ramping up.  OGD’s Director Kathleen Uhl expects 150 FTEs (in FDA-speak, that means people) to be on board in OGD by the end of the year.  That is about half of all hires for just OGD under the GDUFA program. It takes a long time to train reviewers and for that, I agree with Dr. Uhl that we should not expect any “immediate” impact on the generic drug review process, and the numbers bear this out.

This is not totally unexpected, given the magnitude of the implementation of GDUFA, the need to train and assimilate the new employees into the program, but along, with the anticipated decrease in submissions based on the imposition of the fees under GDUFA, the impatient generic industry is looking for more progress.  Remember, there are no metrics under GDUFA until the year three cohort of submissions.

In FY 2012, receipts of new ANDAs soared to the largest one year total of 1103.  ANDA approvals that year totaled 517.  OGD received 3645 Supplements in 2012 and approved 2997, or about 648 supplements more than it approved.  While there were a number of withdrawals of ANDAs and supplements, you cannot gain on the backlog by taking in more than you are putting out – It is like deficit spending, until your income exceeds your expenses you are falling further behind.

The gap in receipts and approvals for 2013 look much the same, except receipts of ANDAs are down and approvals look to be down proportionally.  Estimates based on the current figures show that total FY receipts of original ANDAs will be about 880 or around 225 less than in FY 2012, and approvals will be about 440 down over 60 from 2012.  In FY 2013, OGD is on pace to receive about 4100 supplements, but approve only about 3383,  representing a gap of 717 more than it approved.

The fast-paced and competitive generic industry has never been what one might call patient!  Judging by some firms’ reactions, the honeymoon may be coming to an end .  Firms are actively seeking new dedicated positions to keep close contact with OGD regarding the progress of submissions, and many have increased their presence in the firms’ Washington, DC offices.  This is a bad signal for OGD as they can expect to be called and prodded to release more information about the status of pending applications.  We have heard more “it is under review” responses from project managers recently without any additional information on where the application really is in the review process.  This is not something that industry is happy about.

OGD must gain control of the process and Complete Response Letters (CRLs) are one way OGD is attempting to handle the number of submissions.  While CRLs are a good idea, it does not help the hypercompetitive generic industry when attempting to resolve its deficiencies from the various disciplines.  Many firms would still rather get questions when a specific review is complete so they can begin work and respond to FDA on those issues, rather than wait until all reviews are complete and prepare a comprehensive complete response.  The practice of piecemeal response is very inefficient for OGD and has clearly contributed to the increase in the backlog.

At last month’s GPHA/FDA CMC workshop, OGD promised to concentrate on priority supplemental applications.  The OGD June Statistical report shows the backlog of supplements deceased by about 200 to 5783 after almost 10 straight months of increase, but the number of ANDAs in the backlog (all original applications pending before OGD) began to rise again.

The industry will be watching the progress of OGD very closely and hopefully (we all sincerely hope) that OGD begins to show progress, but like fingernails dragging on the blackboard, the lack of information flowing from OGD about applications appears to be hitting a sensitive nerve with industry.  Industry is expecting more transparency and movement under GDUFA.  They don’t see either yet.  OGD is being put to the test and, since industry is funding the effort with its money in form of GDUFA fees, it expects the test scores to improve.  How long their patience will hold out is anyone’s guess.