As a result of new regulatory responsibilities and evolving drug development activity in certain therapeutic areas, the U.S. Food and Drug Administration (FDA) is announcing a realignment within its Center for Drug Evaluation and Research’s (CDER), Office of New Drugs (OND), effective May 2, 2011.
The Office of Antimicrobial Products (OAP) is one of six Offices of Drug Evaluation (ODEs) that are part of the Office of New Drugs (OND) in CDER. Prior to the re-organization, OAP was comprised of three review divisions: the Division of Anti-Infective and Ophthalmology Products (DAIOP), the Division of Antiviral Products (DAVP), and the Division of Special Pathogen and Transplant Products (DSPTP).
The Agency has realigned review functions within OAP to enhance the logical groupings of applications managed by its review divisions and to achieve a more balanced workload across the divisions. A major focus of this reorganization is to consolidate oversight of all systemic non-antiviral antimicrobial products into one division. The oversight of these applications was previously split between two divisions in OAP. This consolidation will enhance the efficiency to the Agency’s efforts to address issues that are of particular concern in these therapeutic areas, including antibacterial resistance, clinical trial design and guidance to sponsors developing new antimicrobial drugs, and updating the susceptibility test interpretive criteria (i.e., "breakpoints") in product labeling.
The realignment has required reassignment of current INDs, NDAs and BLAs to newly organized divisions within OAP. However, since the majority of FDA staff members evaluating those applications are being concurrently reassigned to these divisions, FDA expects minimal impact of this realignment on the review of current applications. Applications already submitted to FDA will retain their current application numbers and due dates.Please see “Realignment of Current INDs, NDAs and BLAs”
Specific changes related to the OAP realignment are as follows:
DAIOP has been renamed the Division of Anti-Infective Products (DAIP). DAIP will oversee the regulation of all antimicrobials (including antibacterial, antifungal and antiparasitic products), with the exception of antivirals and certain topical antimicrobial products. Antimicrobial products and review staff reviewing antimicrobial products previously assigned to the DSPTP have been transferred to DAIP.
The Division of Special Pathogen and Transplant Products has been renamed the Division of Transplant and Ophthalmology Products (DTOP). DTOP will oversee the regulation of solid organ transplant and ophthalmology products. Ophthalmology products and review staff reviewing ophthalmology products previously assigned to DAIOP have been transferred to DTOP.
The Division of Antiviral Products (DAVP) will remain unchanged.
Both of these newly named and realigned divisions remain in OAP. The following is a listing of key officials and contact information for OAP that reflects the new realignment:
Edward Cox, M.D., M.P.H, Director
John Farley, M.D., M.P.H., Deputy Director
Katherine Schumann, Associate Director for Regulatory Affairs (Acting)
Barbara Styrt, M.D., Associate Director for Medical Countermeasures
Sumathi Nambiar, M.D., M.P.H., Director
Vacant, Deputy Director
Joseph Toerner, M.D., Deputy Director for Safety
Frances LeSane, Chief, Project Management Staff
Maureen Dillon Parker, Chief, Project Management Staff
Renata Albrecht, M.D., Director
Wiley Chambers, M.D., Deputy Director
Ozlem Belen, M.D., M.P.H., Deputy Director for Safety
Diana Willard, Chief, Project Management Staff
Judit Milstein, Chief, Project Management Staff
Debra Birnkrant, M.D., Director
Jeffery Murray, M.D., M.P.H., Deputy Director
Poonam Mishra, M.D., Deputy Director for Safety
Karen Winestock, Chief, Project Management Staff
Victoria Tyson, Chief, Project Management Staff