The US Food and Drug Administration's (FDA) Director of the Office of Generic Drugs (OGD), Greg Geba, will resign effective 15 March 2013 over disagreements regarding his vision for the office, the agency wrote in an email to its internal staff.

Background

The departure comes just months after Geba took the position. In July 2012, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), announced the hiring of Geba from Sanofi, where he served as deputy chief medical officer. At the time of hiring, FDA said it was particularly pleased with Geba's track record, which included "more than 20 currently marketed drugs or devices across multiple therapeutic areas."

Regulatory Focus noted at the time that Geba was coming on board just as FDA was being tasked with implementing the terms of the Food and Drug Administration Safety and Innovation Act, a huge piece of legislation that for the first time ever allows FDA to collect drug user fees from generic pharmaceutical industry sponsors. That money is expected to help FDA conduct more inspections, clear a massive backlog of generic applications and make regulatory improvements.

But Geba's hiring also came just months before Woodcock announced changes within the Office of Generic Drugs, including its elevation to a so-called "super office," affording it greater operational authority and control over reorganized sub-agencies. Before the reorganization, OGD was a sub-office of the Office of Pharmaceutical Science (OPS).

During that same reorganization, Woodcock proposed the formation of a new Office of Pharmaceutical Quality to oversee drug quality throughout the product lifecycle. Woodcock said the office would, if created, assume some functions currently vested in OPS and the Office of Manufacturing and Product Quality.

"Quality is the underpinning of everything we do, and it is imperative that we have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety," said Woodcock. "We must be strategic and have systems in place to identify and respond to quality issues before they become problems. This is especially critical due to the global nature of drug manufacturing and the sourcing of raw materials outside of the US."

Departure

But those changes seem to have created tensions at FDA regarding the changes. Woodcock's 13 March 2013 email explains that, "With the pending realignment of OGD's CMC functions into the new Office of Pharmaceutical Quality (OPQ), 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."

Those challenges evidently were exacerbated by Geba's family, which had not yet relocated to the Washington, DC, region with Geba, Woodcock said.

In the interim, Woodcock said that she would be assuming the position of acting director of OGD while the agency starts its search for a new director.

Geba's entire letter to FDA staff may be found below:

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