REMS Daily Archives
FDA Considering âSuper Officeâ of Drug Safety within Drug Center
Apr 5, 2011The 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.
At the moment, it’s 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.
But it seems clear FDA has two aims behind the idea of a “super office”: 1) elevate the visibility of CDER’s safety functions; and 2) provide the CDER Director with more support.
There a number of ways FDA could accomplish those goals. 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 org chart; however, that does not appear to be the direction the agency is headed in initially.
