FDA Chief of Generic Drugs Hits Exit After Only 8 Months

FDA Chief of Generic Drugs Hits Exit After Only 8 Months

March 14th, 2013 // 2:24 pm @

March 14, 2013

After just eight months at the FDA, Greg Geba is leaving his job as director of the Office of Generic Drugs over differences that emerged following a recent reorganization. His departure, which takes effect on Friday, comes at an inauspicious moment because the FDA, for the first time, recently began collecting user fees from generic drugmakers as part of a plan to speed approvals and fund added inspections.

Avoid FDA – Move to Kansas 🙂

Moreover, Geba arrived just two months before the Office of Generic Drugs was elevated to a so-called ‘super office,’ which meant the OGD became an umbrella for other offices and reports directly to Janet Woodcock, who is director of the Center for Drug Evaluation & Research. At the same time, the Office of Pharmaceutical Quality was created and became responsible for overseeing quality throughout the life cycle of a drug (back story).

“With the pending realignment of OGD’s CMC (Chemistry, Manufacturing, and Controls) CMC functions into the new Office of Pharmaceutical Quality, which Dr. Geba fully supports as part of the quality evolution in CDER, he nonetheless saw this movement as creating challenges for implementing his original and full vision for OGD’s remit,” Woodcock wrote in an e-mail to FDA staff. For now, she will assume his responsibilities.

We wrote Geba to ask if he was aware of the pending reorganization at the time he was hired and why his family had not already relocated; we will update you accordingly. His departure was first noted by Bob Pollock, a senior advisor at Lachman Consultants and a former acting deputy director at the OGD.

Not surprisingly, Woodcock’s e-mail closely tracks the language that Geba, who had been deputy chief medical officer for the US operations at Sanofi before arriving at FDA (see this and this), used in a memo to OGD staff earlier today. “The pending realignment of OGD’s CMC functions and movement of the chemistry divisions into the proposed new Office of Pharmaceutical Quality inevitably resets the scope of responsibilities and remit of our office,” he wrote.

“As I see it, two of the original reasons I came to OGD, to help pave the way for extension of generics across the entire therapeutic spectrum from solid oral dosage forms to complex drugs, from pills to inhalers to topical creams, and to address issues such as pill size, shape, color and the importance this may have for patients who use generics, would be challenged by resources needed for application to other extremely important efforts of the chemistry group in moving to OPQ,” he continued.

“This move, which I entirely support, will further enhance the quality of generic drugs in a proposed new office that is dedicated to a critical new mission, in which the CMC review of generic drugs is consolidated with that of new drugs. This change, coupled with pressing needs to co-locate with my family where we all would be best able to meet our aspirations as individuals – in school and in work – has put into new perspective considerations for relocating to the Washington, DC, area,” he explained.

As he prepares to walk out the door, Geba boasted that OGD has issued nearly 600 complete response letters and approved nearly 200 Abbreviated New Drug Applications since the user fee collections began last October. And he claims the backlog of pending applications that numbered 2,762 last September 30, 2012, has dropped to 2,166 as of last week, but was accomplished with “only a modest increase in staff.” He added that OGD remains “significantly understaffed,” though, and more than 100 people are expected to be hired in the next several months.

Here is the complete Geba note:

From: Geba, Gregory
Sent: Wednesday, March 13, 2013 1:15 PM
To: CDER-OGDALL
Subject: Transitions

March 13, 2013

Dear Colleagues in OGD,

I am writing to you today to inform you that, after much deliberation, effective end of business on March 15th, I will resign my post as Director of the Office of Generic Drugs, an organization that I have been truly privileged to serve.

The pending realignment of OGD’s CMC functions and movement of the chemistry divisions into the proposed new Office of Pharmaceutical Quality inevitably resets the scope of responsibilities and remit of our office. As I see it, two of the original reasons I came to OGD, to help pave the way for extension of generics across the entire therapeutic spectrum from solid oral dosage forms to complex drugs, from pills to inhalers to topical creams, and to address issues such as pill size, shape, color and the importance this may have for patients who use generics, would be challenged by resources needed for application to other extremely important efforts of the chemistry group in moving to OPQ. This move, which I entirely support, will further enhance the quality of generic drugs in a proposed new office that is dedicated to a critical new mission, in which the CMC review of generic drugs is consolidated with that of new drugs.

This change, coupled with pressing needs to co-locate with my family where we all would be best able to meet our aspirations as individuals – in school and in work – has put into new perspective considerations for relocating to the Washington, DC, area.

I want to thank you all for the substantial efforts you have made in driving so much progress in the last five months, since GDUFA was implemented. I will summarize here what I think we all need to applaud.

Thanks to the focused efforts of a dedicated staff, the office has issued nearly 600 complete response letters and approved nearly 200 ANDAs since the GDUFA implementation date of October 1, 2012. I should note that these efforts, the energy required to do this, your dedication to this task, has resulted in a substantial decrease in the backlog. On 9.30.12 GDUFA backlog pending applications numbered 2762; last week, just 5 months after the GDUFA ‘start’ date, with only a modest increase in staff, that number was 2166.

It is known that the organization remains significantly understaffed given the inflow of new applications. However, we are poised to hire more than 100 associates to join the ranks of OGD in the next months and have already identified a large number of candidates, representing 75% of this number in early March. There is more work to be done to ensure that those hired arrive in Rockville before the end of the fiscal year, but this augurs very well for meeting GDUFA hiring goals for the first year and for double that number to be hired next year. Coupled with the assistance of outside consultants, we are examining the creation of a new project management group proposed to create cross-functional project managers who will monitor and orchestrate activities across all the divisions that contribute to the review and approval of generic drug applications. We believe that this will increase coordination of our reviews and reduce cycle times.

We continue to support important regulatory science initiatives this fiscal year with a very talented science staff, and are preparing a public meeting to discuss proposals for topics to be addressed in FY14. Senior members of OGD have reached out to the generic industry via the Generic Pharmaceutical Association and met with their leadership, as well as with other individuals representing generic pharmaceutical firms, to get their perspective and provide guidance to enhance quality of applications, quality of manufacturing and continued monitoring of clinical performance, with special attention to address complaints identified by clinicians and patients. We need to continue this outreach.

In addition, considerable effort has been made to develop the most effective structure for the new OGD, with the input of key members of OGD’s management group, OPS, OM and many others across our and the greater CDER organization. Once finalized, it is expected that this will lead, with continued focus of the organization, to greater efficiency and effectiveness of our reviews, as well as better decision making.

In closing, I wanted to thank you all for your dedication as true servants of the public, your special esprit de corps, and your ability to get things done despite the challenges. It has been an honor and privilege to have served with you in expanding availability of affordable, high quality generic drugs to the American public that we serve.

Best wishes,

Greg Geba

H/T: Pharmalot


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