Office of Generic Drugs “Super Office” Becomes a Reality; New “Office of Generic Drug Policy” Will Handle Hatch-Waxman Issues

By Kurt R. Karst –      

In a recent memorandum to Center for Drug Evaluation and Research (“CDER”) staff (reprinted below, and a condensed version of which was posted on FDA’s website, here), CDER Director Janet Woodcock, M.D. announced that the Department of Health and Human Services approved the reorganization of FDA’s Office of Generic Drugs (“OGD”).  The proposed elevation of OGD into a “super office” was announced in September 2012 (and was even the topic of legislation introduced in March 2012 as we previously reported), just months after the enactment of the Generic Drug User Fee Amendments (“GDUFA”).  The reorganization of OGD is intended to, among other things, make it easier for the Office to meet “the evolving needs of generic drug review” and GDUFA performance goals.  Another recent announcement that FDA and the European Medicines Agency are launching a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals may also go a long way to help FDA meet its GDUFA goal of achieving parity of inspections for foreign and domestic manufacturing facilities.

The reorganization – actually, an almost total restructuring – of OGD as a result of GDUFA has been a hot topic of discussion and debate here on this blog (see our previous posts here and here) and in the generic drug industry in general.  At the Generic Pharmaceutical Association Fall Technical Conference, several presenters from OGD, including Acting OGD Director Kathleen “Cook” Uhl, M.D. and OGD Regulatory Counsel Keith Flanagan laid out in presentations the Office’s accomplishments and introduced the GDUFA Steering Committee – a committee composed of senior FDA personnel to oversee GDUFA implementation and to ensure alignment across CDER components. 

According to Dr. Woodcock, a new OGD-centric team has also been formed – the “OGD Transition Team” – to implement the new OGD super office and reporting structures.  The new OGD structure will consist of four offices (with various divisions): (1) the Office of Research and Standards; (2) the Office of Bioequivalence ; (3) the Office of Regulatory Operations; and (4) the Office of Generic Drug Policy. 

This last office – the Office of Generic Drug Policy – includes the Division of Legal and Regulatory Support and the Division of Policy Development, and it really caught our attention.  Why?  Because, as we understand it, one of the major focuses of this office will be handling and resolving Hatch-Waxman disputes.  Previously, disputes over issues like 180-day exclusivity eligibility and forfeiture were handled by a conglomeration of FDAers from various Agency components.  Bringing together a team of attorneys and regulatory professionals – which likely means that FDA/OGD will be on a hiring spree to bring on board some bright young attorneys – should be a welcome move for the generic drug industry.  Like the CDER Exclusivity Board, which focuses on 5-year new chemical entity exclusivity, 3-year new clinical trial exclusivity and exclusivity for biological products, but not on 180-day exclusivity (or orphan drug exclusivity), and that is intended to bring clarity and consistency to exclusivity decisions, a division or group within OGD to handle ANDA and 180-day exclusivity issues and disputes could bring greater clarity (and speed?) to FDA’s decisions and decision-making process.  It may also mean a change in how FDA does business to address disputes, and could result in some innovative thinking on how to better inform the generic drug industry about 180-day exclusivity forfeitures or whether another applicant’s eligibility for exclusivity will block approval. 

Janet Woodcock Memorandum to CDER Staff (December 2013)

CDER Staff:
 
In September 2012, with the historic passage of the Generic Drug User Fee Amendments of 2012 (GDUFA) and a heightened public focus on generic drugs, I announced plans to elevate the Office of Generic Drugs (OGD) to a “super office” – an office that houses subordinate offices within its organizational structure and which reports directly to me. This reorganization will strengthen OGD’s operations and allow the office to meet the evolving needs of generic drug review.
 
Today, I am excited to inform you that the OGD reorganization has been approved. Acting OGD Director Kathleen “Cook” Uhl, M.D. will continue in this role, leading our generic drug program, executing on our GDUFA performance obligations and enhancing our ability to ensure timely access to high-quality, safe, and effective generic drugs.
 
Generic drugs make up 84 percent of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. These individuals depend on FDA to ensure that generic drugs perform clinically in the same way as their brand name counterpart drugs. Transforming OGD into a super office is a critical and necessary step in recognizing the importance of generic drugs to public health and our national economy. As a super office, OGD will coordinate and manage the abbreviated new drug application (ANDA) review process, provide safety, surveillance, clinical, and bioequivalence reviews for generic products, as well as contain new offices to develop policy and regulatory science for generic drugs. It will also integrate all Risk Evaluation and Mitigation Strategy (REMS) and safety labeling issues with other CDER offices.
 
Under GDUFA, FDA made a commitment to achieve certain performance goals. I am pleased to announce that we met or exceeded all of our Year One GDUFA goals. For example, the user fee collection system is in full operation, first-year user fees have been collected, and we exceeded our first-year hiring goals.
 
Next Steps
 
An OGD Transition Team is implementing the new office and reporting structure. OGD will have a centralized administrative support function and centralized project management for both review and policy work. OGD will have its own governance structure which means it will set its own policy and strategic agenda, ratify its own budget, resolve any disputes, and perform as an executive team. The approved structure consists of the following:

• Office of Research and Standards (includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling)
• Office of Bioequivalence (includes three divisions of bioequivalence and a Division of Clinical Review, which includes the OGD Safety and Surveillance Team)
• Office of Generic Drug Policy (includes the Division of Legal and Regulatory Support and the Division of Policy Development)
• Office of Regulatory Operations (includes a Division of Project Management, a Division of Labeling Review, a Division of Filing Review, and a Division of Quality Management Systems)

The Transition Leads for the above offices are Robert Lionberger, Ph.D., John Peters, M.D., Keith Flanagan, J.D., and Jason Woo, M.D., respectively. The Transition Team also includes Cook, Kristin Hornberger (acting senior management officer) and Mary Dempsey (associate director for regulatory affairs). 
 
To keep OGD staff involved in the reorganization and informed of the implementation plans, the OGD Transition Team will hold several upcoming “lunch and learn” information sessions. These sessions will offer an opportunity to discuss the office’s future structure and its related functions with OGD staff. 
 
As a part of the Office of Pharmaceutical Quality (OPQ) proposal, OPQ is proposed to house the product quality-related groups, including CMC and Microbiology review functions, which had previously been in OGD to ensure efficiency and consistency of standards and actions across the Center and drug product lifecycle. As OGD is now a super office, approximately 200 CMC and Microbiology reviewers in OGD will remain in the Office of Pharmaceutical Science, and then move into the new OPQ when it is established. The impact of these proposed OPQ changes will be reviewed in advance and negotiated, as applicable, with the National Treasury Employees Union (NTEU) in accordance with the FDA NTEU Collective Bargaining Agreement.
 
The OGD reorganization is a part of our ongoing efforts to ensure that the generic drug industry is held to standards of high quality – and our ongoing efforts to expedite the availability of safe, effective, and high quality generic drugs to patients. It also underscores our commitment to maintaining the public’s confidence in an Agency that continues to meet the ever-changing needs of the American public health.
 
I want to thank Cook, the OGD Transition Team, and all those individuals who have worked so hard and so diligently to make this reorganization a reality. Congratulations on achieving this important milestone.
 
Janet Woodcock