FDAnews Drug Daily Bulletin


Nov. 8, 2005

The FDA proposed realignment of the Center for Drug Evaluation and Research (CDER) calls for the creation of a new office dedicated to the agency’s Critical Path Initiative, as well as a major restructuring of the center’s drug safety activities. The realignment plan, which the FDA hopes to fully implement over the next six months, builds upon last month’s announcement by CDER Director Steven Galson, who revealed the agency was planning major changes to CDER to better align staff functions with CDER goals and FDA public health mission.

Among the key proposals, according to a recent memo from Galson, is the formation of a new CDER office devoted solely to Critical Path. Launched in March 2004 as part of the FDA efforts to speed drug development, Critical Path has been touted as a top priority by agency officials but has been largely slowed by funding shortfalls and other hurdles.

The Center could greatly enhance the process to develop drugs more quickly, safely and effectively if staffed to provide sufficient assistance and advice to developers and to sustain public/private partnerships to improve drug development,” Galson memo states. “To date, the Center has not been staffed to support needed work on the Critical Path and has not been configured to provide organizational ‘ownership’ of these activities.

The new office, which would include the current Office of Clinical Pharmacology and Biopharmaceutics and the Office of Biostatistics, would help CDER prioritize its Critical Path efforts and spur more cooperation with other federal agencies, CDER Deputy Director Douglas Throckmorton said during a recent meeting of the agency Science Board. I am very confident [the new office] will make a difference in the effectiveness of the Critical Path program, Throckmorton added.

In addition to creating the new Critical Path office, the reorganization plan calls for the formation of a new advisory group, reporting to the Office of Medical Policy, to address Critical Path projects in the area of clinical trial design and analysis.

The second component of the CDER realignment is an overhaul of the center’s drug safety organizational structure. According to Galson, CDERcurrent structure ;perpetuates the misperception that ensuring drug safety is solely the responsibility of the current Office of Drug Safety (ODS). The realignment will address this misperception by emphasizing the center; multi-disciplinary approach to drug safety activities, Galson added.

The proposed organizational changes affecting drug safety include: appointing a new associate center director to focus on broad drug safety policy and safety communication; consolidating certain drug safety-related activities to report to the new associate center director, including the agency MedWatch program and Drug Safety Oversight Board; and elevating the status of the current ODS to report directly to the center director. The name of the ODS will be changed to more accurately reflect the range of activities it performs, Galson said.