FDA update – April 4, 2011

FDAs “Super Office” of Drug Safety within CDER:

The agency is looking into the creation of a new position that would oversee FDA’s multiple drug safety initiatives. FDA is in the early stages of searching for a new head of a "super office" of drug safety within the Center for Drug Evaluation & Research. It’s yet unclear whether the position will oversee a newly constituted drug safety office or the agency is attempting to fill the Associate Director of Safety Policy & Communication position left vacant with the departure of Paul Seligman.

FDA has two aims behind the idea of a “super office”:

• Elevate the visibility of CDER’s safety functions.
• Provide the CDER Director with more support.

Presently, the Office of New Drugs and the Office of Surveillance & Epidemiology have equal status on the CDER organizational chart and through a memorandum of agreement, known as Equal Voice.

FDA could simply move OSE one step up in the organizational chart or add a new senior manager in the position of deputy director to a small unit of senior advisors to current CDER Office. The creation of an elevated office and/or senior position is becoming more of a necessity as the drug center’s safety efforts become larger and more diffuse:

• The active surveillance Sentinel Initiative
• The Med Watch voluntary reporting system
• The Safety First program aimed at applying PDUFA-like tracking management to drug safety measures.
• Risk Evaluation & Mitigation Strategies (REMS) programs associated with product approvals and evaluating the regular assessments of those programs

The Safe Use initiative aimed at improving adherence and reducing medical errors

CDER’s highest ranking drug safety official is Gerald Dal Pan, who currently heads up OSE. Although FDA is conducting a “national search,” Dal Pan could be elevated to the new position from within.

The agency has brought in experienced hands from previous reorganizations to aid with the drug safety position search and reorganization of the Office of the Commissioner, which is ongoing according to FDA. John Taylor current serves as the Acting Principal Deputy Commissioner following the departure of Joshua Sharfstein to lead the Maryland health department. That position may be eliminated as part of the reorganization.

Any questions on this new FDA office please email us at info@mdiconsultants.com and Ref: Super Office.