After the issuance of MaPP 5200.3 back in September 2013 (see previous post here) relative to communication with industry, voices rang out in pain as the Generic industry felt as if its lifeline to information concerning the status of its applications were completely cut off. After a cacophony of complaints voiced by both GPhA and a number of firms in the Generic Industry, as well as at least one blogger, OGD has listened. Describing industry’s practices of constant contact with various OGD staff prior to and after GDUFA implementation, Dr. Uhl said “This practice was very resource intensive for us, and sometimes inadequately documented. It could also result in differential treatment of similarly situated applicants, giving rise to fairness and consistency issues.”
OGD recognizes that industry must have some information in order to run its business in an efficient and meaningful way and for making planning, manufacturing, and marketing decisions. In a recently issued (January 28, 2014) memo to the US Public Health Service (USPHS) Commissioned Corps Officers (CCO) assigned to OGD, the program will initiate a rather labor-intensive program to develop a complete inventory of all of each firm’s original applications (not supplements) to provide a one-time snapshot of all of where each firm’s applications are in the OGD review queue.
Why is OGD taking on this resource-intensive and special initiative and why are they using only the CCO to complete this task? Dr. Uhl notes in the memo “[T]he inventory and update goes above and beyond our negotiated GDUFA commitments. It represents an extra effort to improve transparency, and help stakeholders cope with some of the uncertainty and disruption created by GDUFA implementation.” Being a former CCO myself, it is recognized that CCOs are on duty 24/7 and are not subject to overtime rules. CCOs are often called upon for special assignments, disaster relief efforts, or other national health emergencies. Clearly FDA recognizes that “GDUFA is an important public health priority” as the approval of generic drugs has saved consumers and the government $1.3 trillion over the last decade. It appears OGD did not want to disrupt the normal day-to-day work load or output or utilize overtime pay for civil servants (which would cut into GDUFA funds used for normal review activities) by adding this additional function to routine activities as that could adversely impact their ability to meet their GDUFA review goals. Thus, they have called on the CC Officers to tackle this project after normal working hours requesting that each CCO “perform an additional 8 hours of additional duty each week to support the effort”.
Each firm of record will likely get an official correspondence from OGD in some written form when the project is completed that will give a snapshot of where their application is in the review queue. OGD is hoping that this will help provide some transparency for industry. While this is going to be a one-time effort and may not be as granular as industry might like, after meeting with GPhA and listening to the industry as a whole, this is a very good first step. This does indicate that OGD has recognized industry’s frustration relative to the need for information and they are taking this extraordinary effort to help improve communications and transparency.
OGD has scheduled this project to begin February 1, 2014 and anticipates it should be completed by the end of the month with firms being notified shortly after the work is finalized.
It is also clear that OGD is working on additional initiatives to improve communications. Apparently, Dr. Uhl has heard the industry and, where possible, new initiatives to improve transparency and communication will be incorporated into the OGDs work plan.
GDUFA is a complicated animal and OGD and industry are learning just how complex and difficult the transition to this new paradigm really is. OGD is committed to working with the industry while meeting its statutorily mandated GDUFA performance goals. This should be music to the ears of the generic drug industry, even if some of the notes have been sour, and it is nice to see that OGD is working efficiently and under the constraints of GDUFA to keep the song in tune. Will this be enough to appease industry? Hopefully, it will at least provide some breathing room as OGD gears up for the year 3 cohort of application subject to GDUFA metrics to be submitted beginning on October 1, 2014. Remember industry – this special initiative is over and above any GDUFA commitment the Agency has made! Let give OGD kudos for this.
