In a passionate presentation before a packed GPhA audience that left some teary-eyed, Dr. Uhl the Acting Director of the Office of Generic Drugs (OGD), whose nickname we learned is “Cook”, outlined her strategy for achieving the demanding goals of GDUFA on time.
Reminding the listeners that OGD has met all GDUFA year-one goals, she noted that in order to meet future year goals, especially beginning in year three, depends on a concerted effort with OGD and Industry working together. There is no point in looking at how things were done in the past, she said; GDUFA requires creating a new approach to the review process for OGD, as well as a need for the Industry to improve the quality of its applications and the way it communicates with OGD, to paraphrase her remarks.
Dr. Uhl outlined the OGD accomplishments during the first year of GDUFA and acknowledged that the truly difficult objectives will come when the GDUFA metrics kick in in year three of the five year program. Cook also noted that there was no chance that the status quo would work and it was time to move forward, saying that is the only direction in her vocabulary. After telling the GPhA crowd what she and her team were willing to do she outlined FDA’s top 3 priorities, GDUFA, GDUFA and GDUFA, she then challenged the Industry to ask what they are willing to do to help this necessary partnership between FDA and Industry work. “OGD is not in this alone”, Uhl said; “I expect you to take an active part in making this program work.”
The only way GDUFA can work (as was stated by Cook and others during the three-day conference) is to improve the quality of the applications coming in, and reduce the number of review cycles to ANDA approval. FDA is in the throes of a much-needed revamp of the review and approval process and Industry must now step up to the plate and do its part.
After listening to her passionate and sincere presentation, it appears that Dr. Uhl may be the spark that the Agency has been looking for to ignite the program in the best way possible. Sure, feathers have been ruffled on both sides of the FDA – Industry aisle, but with the enormity of the “transformational change” (coined by a Mylan presenter at the meeting) in process, policy and program coupled with tight timelines for meeting congressionally-mandated goals and an overwhelming workload, perhaps if all that is ruffled are feathers, the recipe will avoid a “Cooked” goose for both FDA and Industry.