The Office of Generic Drugs’ (OGD) elevation to a Super Office in the Center of Drug Evaluation and Research has come at a challenging time for the Generic Drug Program. The new Office structure is presented below and represents a dramatic organizational change to us old timers. But this is progress and represents the need to move the program in a different direction for today’s environment.
Office of Generic Drugs: Offices and Divisions
- Immediate Office
- Clinical Safety Surveillance Staff
- Program Management and Analysis Staff
- Communications Staff
- Office of Research and Standards
- Division of Therapeutic Performance
- Division of Quantitative Methods and Modeling
- Office of Bioequivalence
- Division of Bioequivalence 1
- Division of Bioequivalence 2
- Division of Bioequivalence 3
- Division of Clinical Review
- Office of Generic Drug Policy
- Division of Legal and Regulatory Support
- Division of Policy Development
- Office of Regulatory Operations
- Division of Policy Management
- Division of Labeling Review
- Division of Filing Review
- Division of Quality Management Systems
Key senior management positions have been formalized (see below), but Dr. Uhl remains in her acting Director’s position.
- Rob Lionberger will lead the Office of Research and Standards (ORS), which includes the Division of Therapeutic Performance and the Division of Quantitative Methods and Modeling.
- John Peters will lead the Office of Bioequivalence (OB), which includes the three Divisions of Bioequivalence and the Division of Clinical Review.
- Jason Woo will lead the Office of Regulatory Operations (ORO), which includes the Division of Filing Review, the Division of Labeling Review, the Division of Project Management, and the Division of Quality Management Systems.
- Keith Flanagan will remain as transition lead for the Office of Generic Drug Policy (OGDP), which includes the Division of Policy Development and the Division of Legal and Regulatory Support.
As industry learns to interact with the “new” OGD, both OGD and industry struggle with many challenges. The new organization will strengthen the Agency’s ability to deal with those challenges. But the wild card for success is in details such as:
- Will the crush of ANDA submissions continue?
- Will inspections begin to catch up with reviews?
- Will the OGD IT systems be updated to provide better support for communication with industry regarding the status of pending applications?
- Will risk-based review become a reality that will help OGD out of the huge backlog it faces?
- How fast will new reviewers come up to speed?
- What court challenges will OGD face relative to some of its decisions?
- Where will FDA come out on the generic drug labeling proposal?
These issues clearly represent only a few of the many “details” that will make or break the program and will shape, or at least set the tone for the negotiations for GDUFA II. All we can do from the outside is wait to see how OGD is able to handle these issues and offer our suggestions for improvement, comment on draft guidance document and policy issues, and work closely with our professional associations to enlist support of the entire generic industry.