Reports that the Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), Janet Woodcock, is to retire next year were brandished around both the trade and mainstream media Thursday.
However in a memo sent to staff at the CDER yesterday, Woodcock said: “I want to assure you that I am not planning to retire as erroneously reported in the media today.”
“In fact, quite the opposite is true. I am becoming more deeply involved in many of the Center’s issues, including the proposed reorganizations of the Office of Pharmaceutical Quality and the Office of Generic Drugs.”
The press jumped on speculations as to who with might replace the regulatory powerhouse with Reuters reporting that no one has been groomed to takeover. Robert Meyer, a former medical reviewer at the FDA said: “No-one is seeing that luminous, next-generation leadership.”
Other reports speculated at potential heirs to the FDA throne, including Dr. Rachel Sherman, Associate Director of Medical Policy and Dr. Richard Moscicki, Deputy Center Director for Science Operations - both at the CDER - or Dr. Karen Midthun, Director of the Center for Biologics Evaluation and Research (CBER).
However, for Woodcock:“The inaccuracy of the media has unnecessarily raised concerns among Center staff, and even among my own family. My daughter emailed me this morning to ask if I’m retiring!
“I continue to be fully committed to the important work CDER does and to its staff who work so diligently to protect the health of the American public."
The CDER is responsible for reviewing and regulating new drug applications, including a number of biologic therapies transferred from the CBER in 2002.