CDER Director Praises Staff for Handling of Meningitis Outbreak and Product Recalls

Nov. 9, 2012

This just in from FDA....


This just in from FDA....

CDER Staff:
During this very busy time for CDER, I want to stop and take a moment to thank all of our staff who have been working around the clock on the meningitis outbreak and the associated recalls of compounded drugs and other drugs distributed by the New England Compounding Center (NECC) and Ameridose.
The outbreak investigation and the product recalls have greatly impacted so many of you in recent weeks. CDER staff members have been working literally day and night with CDC, the Office of Regulatory Affairs (ORA), the Office of Emergency Operations (OEO), the Office of the Commissioner (OC), and many others to coordinate a response to the meningitis outbreak. In addition to containing the crisis, many of our staff have been involved in communicating almost daily with health care providers and patients, media, state health departments, and hospitals across the country, to provide important public health updates.
In early October, we activated CDER’s Crisis Management Group (CMG) to assist with the coordination of our outbreak efforts among CDER staff, CDC, ORA, OEO, and OC. This is the first time since 2008 that we have activated the CMG and CDER’s Situation Room in response to a public health outbreak. (The 2008 investigation was conducted in response to the heparin contamination.)
This core group of FDA staff has led a sustained effort since October -- keeping us informed, on track, and organized. This is no easy task as many of you know. It takes an extraordinary amount of teamwork to confirm the facts, understand the significance of the facts, develop and convey messages in a timely manner, and do so in a way that instills confidence, without causing panic throughout the health care system and with patients.
In addition to the CMG, during this time we have tapped almost every office in CDER for information, assistance, or support in some way. These individuals have responded quickly and cheerfully to sometimes daunting and complex requests.
As we move into the next phases of the meningitis outbreak, we want to ensure that an outbreak like this is not repeated.  We know there is still a lot to be accomplished. A core group of CDER staff will continue to work the investigation, while others are assisting Congressional leaders on potentially new authorities. Other staff will continue to work closely with our sister agencies, while others will continue to communicate our progress to patients and health care providers.
The meningitis outbreak is a tragedy for public health, but it has been a striking example of the competency, dedication, and professionalism of CDER staff. I am proud to witness the level of unwavering commitment at every level of this organization. You serve as an inspiration to your colleagues and know that the American people are being well served by your tireless efforts. It is an honor to lead such an extraordinarily committed group.
Thank you.
Janet Woodcock

About the Author

pharmamanufacturing | pharmamanufacturing