FDA Considering 'Super Office' of Drug Safety

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This article has been reprinted with permission from RPM Report.

FDA Considering "Super Office" of Drug Safety within Drug Center

by Ramsey Baghdadi

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.

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 are a number of ways FDA could accomplish those goals. Presently, the Office of New Drugs and the Office of Surveilance & 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.

FDA could also add a new senior manager in the position of deputy director to a small cadre of senior advisors to current CDER Director Janet Woodcock; Bob Temple currently serves as Deputy Director for Clinical Science and Douglas Throckmorton is Deputy Director for Regulatory Programs within CDER.

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 MedWatch 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.


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