The FDA is restructuring its Center for Drug Evaluation and Research to do a better job of supply chain security and manufacturing oversight, says an FDA memo from CDER Director Janet Woodcock released this week (hat-tip Pharmalot).
Elevating the current CDER Office of Compliance to a “Super Office” opens up more resources and organizational focus to monitoring manufacturing quality and supply chain problems, the memo says, and creates new capacity under the new branch, housing four offices including the brand new Office of Drug Security, Integrity, and Recalls.
In the memo, Woodcock says the new ODSIR will be “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain. ODSIR staff will take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls.” As Pharmalot puts it, the gist of the new Super Office status means Compliance will conduct more of “its own nerve center operations.”
The shift also suggests the agency may be preparing to exercise greater authorities, perhaps including recall and subpoena powers it has asked Congress for in recent years. Deborah Autor, current director of the Office of Compliance, will serve as acting director of the new expanded Office.
In the end, this is a bureaucratic move, but it does signal responsiveness by the agency to the new global scope and structure of the drug supply, which Deputy Commissioner John Taylor has said demands a serious refit of the way FDA does oversight.
From a practical standpoint, the move makes nuts-and-bolts sense, creating technical capacities and pathways needed to begin to modernize the way the agency monitors drug-making. And as a gesture, it reaffirms FDA’s commitment to the public health and safety aspects of its mission, a concern some FDA scientists raised with the new Administration in 2009.
–Kate Petersen, PostScript blogger