And so It Begins! GDUFA Act II

In the Federal Register today, FDA announced a public meeting to be held on June 15, 2015 at the FDA’s White Oak campus.  The purpose of the meeting is to get the public’s input on the potential reauthorization of the Generic Drug User Fee Act (GDUFA).  GDUFA was a 5 year program which will expire at the end of FY 2017 (in government time – that is right around the corner).

FDA want input as to what has and what has not worked and is asking for suggestions as to how to change the essence of the GDUFA goals letter.  There has been lots of industry buzz about GDUFA I and clearly not all positive.  One of the biggest contentions relates to goal success being linked primarily to Complete Response Letters (CRL) rather than approvals.  Industry points to the Hatch-Waxman Act as evidence that the Agency should be assuring that applications move towards approval rather than solely basing goals on CRLs.  Industry point to the basic goal of Hatch-Waxman, to bring high quality generic products at an affordable price to the market at the earliest possible date as its mantra for how GDUFA must change in round II.  While this is a lofty goal, there does need to be some balance as it is difficult to provide a goal of approving an application in a certain fixed period of time based on the disparity in the quality of many applications. In addition, there may be new or challenging scientific issues not previously evaluated by the Agency in any application or an application may present unique issues related to the complexity of a particular product that must be vetted prior to approval.  There are also issues associated with the compliance of facilities from a cGMP standpoint that may delay the approval of an application while the issues are being worked through. None-the-less, industry is clearly looking to land the goals somewhere in the middle.   What that might look like we don’t know, but we certainly expect to see significant discussion on this issue.

Another area that will likely be on the table relates to communication.  The industry is looking for a better way to track the status of applications through the review and approval process.  Certain suggestions of increased access to perhaps a secure IT platform that will allow sponsors to view where their applications stand in the queue or at least some improvement in response time and information available to industry will be a key issue in the negotiations for GDUFA II.  The Agency is responding to these concerns now with the introduction of mid-cycle communication and advanced notice of pending approvals, but industry has not yet had sufficient experience with these new tools to judge their impact, but from what I hear industry may be asking for more.

Both sides have learned during the first half of the 5 year cycle and each side (FDA and industry) likely have wants and asks for the next 5-year cycle.  The first questions are how much will industry’s asks cost and what the generic industry will be willing to pay.  The next question is can FDA deliver on its promises.  So far in GDUFA I there are skeptics on both sides and the second half of the first 5 year cycle will bear out FDA’s  overall performance, which will also dictate whether the industry is  willing to plop down additional revenues.  With the potential of significant increase in government appropriations for the generic program not really in the cards, it seems almost a forgone conclusion that there will be a GDUFA II, but what it will look like is the substance of the occult.

So this first meeting public meeting will set the table for the next half decade of FDA’s generic drug program as negotiations will begin in earnest shortly after the Agency digests the public input.  To see the full Federal Register announcement click here.