Having heard about an important announcement made by OGD last week, I was fortunate enough to receive a copy of an internal email issued by Cook from the CDER trade press office. I read it once, and then reread it about 5 more times. “More changes at OGD” was the bottom line message, and then a question popped into my head. Is this message good news? If it results in more consistent actions coming out of OGD quicker, the answer is yes! When asked about the changes and how this will impact the review process, OGD responded: “With all the process improvements that we are implementing under GDUFA, we anticipate more regulatory actions. The Regulatory Project Managers are responsible for driving the actions to completion and assuring that the freight moves. The Quality Oversight Team ensures quality and consistency in our regulatory actions.”
My read on this is that two very experienced OGDers will be assuring quality and consistency of OGD’s regulatory actions. Based on my experience and knowledge of the individuals involved, these two OGDers (Bob West and Peter Rickman) have the background and gumption to get things done and will likely embrace their new roles. One of West’s previous roles was to corral ANDAs heading for final action and making sure that the applications got to the finish line and got approved or making sure a Complete Response Letter (CRL) letter for an ANDA that was lost in the shuffle got out in a timely manner. This role appears to have transitioned over the last two years to be the responsibility of the Regulatory Project Managers. Peter Rickman also was one person in OGD that always seemed to be able to remove roadblocks to getting thorny ANDA issues resolved, whether it be labeling, a regulatory problem or just getting a stalled ANDA back on track. This is a role now that another will fill. So we will have to see how the old roles and new roles complement each other as this new Quality Oversight Team gets established. Hopefully, the Regulatory Project Managers will pick up the torch under GDUFA and run with it! Keep your eyes open, industry!
Cook’s email also announced the following changes, as well, by saying: “With Bob and Peter leading this critical activity, their former positions as Deputy Director, Office of Regulatory Operations and Director, Division of Filing Review will be filled in an acting capacity by Carol Holquist and Johnny Young, respectively. Kwadwo “Kojo” Awuado will then take on the role of Acting Deputy Director for the Division of Filing Review (Johnny Young’s current role).”
As OGD moves forward into the GDUFA metric world this October, it is reassuring to see that OGD is looking to make moves that are designed to keep the freight moving, with an eye towards consistency and quality regulatory actions. Let’s hope this is one of the many initiatives that can help OGD accomplish their mission. I have included a complete copy of the email as I believe it is important to industry to understand that OGD knows it is in a battle – not a battle with industry, but rather a battle with an unexpected and surprisingly increased workload. As Cook says – “Read the goals letter” – well, I did and the assumption was for receipt of 750 ANDAs per year and, as we all know from previous posts, so far in FY 2014 OGD has received over 1500 ANDAs. How do you deal with this – it will take a village!
From: Uhl, Kathleen (CDER)
Sent: Thursday, August 07, 2014 4:22 PM
Subject: PLEASE READ – Creating a “Quality Oversight Team” in the OGD Office of Regulatory Operations Immediate Office
Dear OGD Staff,
With OGD becoming a Super Office and the ramp-up (e.g., hiring, training and streamlining of business processes) ahead of Year 3 of GDUFA, it should not come as a surprise to anyone that we are preparing for an increase in ANDA workload. As you know, GDUFA Year 3 ANDAs have GDUFA goal dates. In anticipation of this uptick in volume and productivity, we will be generating significantly more ANDA-related actions (e.g., refuse-to-receive (RTRs), approvals (AP), tentative approvals (TA), and completed responses (CR)). Job #1 for OGD, and specifically the Office of Regulatory Operations (ORO), will be to ensure timely and consistent ANDA actions across our ORO divisions and also in coordination with other OGD offices.
Delivering timely and consistent actions (RTRs, APs, TAs and CRs) that meet GDUFA goals is an area of such paramount importance that it warrants attention above the division level of the Division of Quality Management Systems (DQMS). As such, we are creating a Quality Oversight Team (QOT) within the ORO Immediate Office (IO). Both Bob West and Peter Rickman have continuously provided critical input and guidance in helping OGD meet our public health mission, and provided significant input in identifying this urgent need to increase and improve our capacity. Their leadership has been a major contribution to identifying this solution, and, as such, I have asked both of them to assume leadership of the QOT. They will start details in this new team as Associate Director of Review Quality (Bob West) and Associate Director of Submission Quality (Peter Rickman), effective Monday August 11, 2014. This move will leverage their in-depth knowledge and vast experience with OGD, the ANDA submission and review process, and the generic industry; thus ensuring that we are able to meet our GDUFA goals heading into Year 3. I appreciate their insights into helping us establish this team and agreeing to take on these new roles that will be pivotal to our success.
We also will be staffing up the Quality Oversight Team with several detail positions, possibly on a rotating basis. We anticipate announcing the QOT detail positions in the very near future. This team will have the responsibility for oversight of all ANDA-related actions, and more importantly will develop the initial quality program for ORO’s review actions. I encourage staff members to seriously consider applying for these details, once announced. The details will be an incredible opportunity to not only learn from Bob and Peter and their years of experience, but also to refine the review process to best position OGD to meet its GDUFA goals.
With Bob and Peter leading this critical activity, their former positions as Deputy Director, Office of Regulatory Operations and Director, Division of Filing Review will be filled in an acting capacity by Carol Holquist and Johnny Young, respectively. Kwadwo “Kojo” Awuado will then take on the role of Acting Deputy Director for the Division of Filing Review (Johnny Young’s current role). As I have mentioned at numerous All Hands meetings, the new leadership positions in OGD (for example, those positions for which someone is currently “acting”) will all be competed via formal vacancy announcements. I encourage OGD staff to consider applying for these positions as we seek to permanently fill the many leadership positions throughout the organization that are a direct result of the Super Office reorganization of OGD.
Thanks again to Bob and Peter for tackling this challenge; they are rising to the occasion at a challenging time for OGD. Their experience, judgment and knowledge are an extraordinary asset. I deeply appreciate their quiet, unselfish and steady leadership.
Lastly, a big “Thank you!” to all of OGD for your patience during the reorganization as well as your continued dedication to the OGD mission.